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Study of Rogaratinib (BAY1163877) vs Chemotherapy in Patients With FGFR (Fibroblast Growth Factor Receptor)-Positive Locally Advanced or Metastatic Urothelial Carcinoma (FORT-1)

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ClinicalTrials.gov Identifier: NCT03410693
Recruitment Status : Completed
First Posted : January 25, 2018
Results First Posted : December 29, 2021
Last Update Posted : September 28, 2022
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Carcinoma, Transitional Cell
Interventions Drug: Rogaratinib (BAY1163877)
Drug: Chemotherapy
Enrollment 175
Recruitment Details This study enrolled participants at 111centers in 28 countries from 31 MAY 2018 (first participant first visit) to 27 OCT 2020 (last participant last visit).
Pre-assignment Details A total of 718 participants signed the informed consent for prescreening, of which 256 participants completed the prescreening, while 462 participants discontinued the prescreening. The discontinuations were due to screening failure (322), other reasons (98), withdrawal by the participant (22), and death (20).
Arm/Group Title Rogaratinib (BAY1163877)_Overall Population Chemotherapy_Overall Population
Hide Arm/Group Description Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle. Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Period Title: Overall Study
Started 87 88
Started Treatment 86 82
Active Follow-up Performed 61 56
Entered Long Term Follow-up 56 69
Completed [1] 0 [2] 0 [2]
Not Completed 87 88
Reason Not Completed
Disc trt: Withdrawal by participant             6             4
Disc trt: Lost to follow up             0             1
Disc trt: radiological progression             58             50
Disc trt: Other             1             0
Study drug never administered             1             6
Discontinued (disc) treatment (trt): Death             6             4
Disc trt: Adverse Event (AE)             13             9
Disc trt: Physician decision             0             5
Disc trt: clinical progression             1             5
Disc trt:AE not asso. w/ clinical disease progress             1             4
[1]
Completed treatment, participants who discontinued treatment could enter follow-up.
[2]
Completed treatment
Arm/Group Title Rogaratinib (BAY1163877)_Overall Population Chemotherapy_Overall Population Total
Hide Arm/Group Description Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle. Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle). Total of all reporting groups
Overall Number of Baseline Participants 87 88 175
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 87 participants 88 participants 175 participants
67.7  (8.3) 66.4  (10.3) 67.0  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Female
75
  86.2%
70
  79.5%
145
  82.9%
Male
12
  13.8%
18
  20.5%
30
  17.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Hispanic or Latino
1
   1.1%
0
   0.0%
1
   0.6%
Not Hispanic or Latino
76
  87.4%
78
  88.6%
154
  88.0%
Unknown or Not Reported
10
  11.5%
10
  11.4%
20
  11.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
23
  26.4%
25
  28.4%
48
  27.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
1
   1.1%
0
   0.0%
1
   0.6%
White
55
  63.2%
55
  62.5%
110
  62.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
8
   9.2%
8
   9.1%
16
   9.1%
Cancer Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Location of primary cancer: bladder
56
  64.4%
45
  51.1%
101
  57.7%
Location of primary cancer: Ureter
17
  19.5%
14
  15.9%
31
  17.7%
Location of primary cancer: Renal pelvis
12
  13.8%
28
  31.8%
40
  22.9%
Location of primary cancer: Proximal urethra
2
   2.3%
1
   1.1%
3
   1.7%
Cancer stage at study entry   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Stage III B
1
   1.1%
3
   3.4%
4
   2.3%
Stage IV
5
   5.7%
12
  13.6%
17
   9.7%
Stage IV A
13
  14.9%
24
  27.3%
37
  21.1%
Stage IV B
67
  77.0%
48
  54.5%
115
  65.7%
Unknown
1
   1.1%
1
   1.1%
2
   1.1%
[1]
Measure Description: Higher value/letter correlates to advanced stages of the malignancy. IIIA: The tumor has grown into the perivesical tissue or has spread to the prostate, uterus, or vagina, but has not spread to the lymph nodes or other organs, or cancer has spread to a single regional lymph node; IIIB: the tumor has spread to 2 or more regional lymph nodes or the common iliac lymph nodes; IVA: The cancer has spread to the pelvic wall or the abdominal wall but not to other parts of the body, or has spread to lymph nodes located outside of the pelvis; IVB: the tumor has spread to other parts of the body.
PIK3CA and/or RAS activating mutations   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Absent
65
  74.7%
69
  78.4%
134
  76.6%
Present
10
  11.5%
10
  11.4%
20
  11.4%
Unknown
12
  13.8%
9
  10.2%
21
  12.0%
[1]
Measure Description: PIK3CA: Phosphoinositide 3 kinase, catalytic subunit alpha isoform RAS: Rat sarcoma
FGFR expression from Targos   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 87 participants 88 participants 175 participants
Negative
13
  14.9%
14
  15.9%
27
  15.4%
Positive
69
  79.3%
69
  78.4%
138
  78.9%
Not assessed
5
   5.7%
5
   5.7%
10
   5.7%
[1]
Measure Description: FGFR: Fibroblast growth factor receptor
1.Primary Outcome
Title Objective Response Rate (ORR) - Central Assessment
Hide Description ORR is defined as the percentage of participants with complete response (CR) or partial response (PR). participants for whom overall best response is not CR or PR, as well as participants without any post-baseline tumor assessment will be considered non-responders.
Time Frame From start of treatment up to end of active follow-up, approximately 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rogaratinib (BAY1163877)_Overall Population Chemotherapy_Overall Population Rogaratinib_WT Population Chemotherapy_WT Population
Hide Arm/Group Description:
Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Rogaratinib arm, wild type population
Chemotherapy group, wild type population
Overall Number of Participants Analyzed 87 88 62 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
19.5
(11.8 to 29.4)
21.6
(13.5 to 31.6)
19.4
(10.4 to 31.4)
23.8
(14.0 to 36.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rogaratinib (BAY1163877)_Overall Population, Chemotherapy_Overall Population
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.6991
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter ORR difference (R-C)
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-14.0 to 9.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rogaratinib_WT Population, Chemotherapy_WT Population
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.7944
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter ORR difference (R - C)
Estimated Value -4.5
Confidence Interval (2-Sided) 95%
-18.9 to 9.9
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Disease-control Rate (DCR) - Central Assessment
Hide Description DCR was defined as the percentage of participants whose overall best response was not a progressive disease (i.e., CR, PR, stable disease [SD] or Non CR/Non PD).
Time Frame From start of treatment till end of active follow-up, approximately 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rogaratinib (BAY1163877)_Overall Population Chemotherapy_Overall Population Rogaratinib_WT Population Chemotherapy_WT Population
Hide Arm/Group Description:
Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Rogaratinib arm, Wild type population
Chemotherapy group, Wild type population
Overall Number of Participants Analyzed 87 88 62 63
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
50.6
(39.6 to 61.5)
55.7
(44.7 to 66.3)
53.2
(40.1 to 66.0)
63.5
(50.4 to 75.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rogaratinib (BAY1163877)_Overall Population, Chemotherapy_Overall Population
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.7962
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter DCR difference (R-C)
Estimated Value -5.1
Confidence Interval (2-Sided) 95%
-19.9 to 9.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rogaratinib_WT Population, Chemotherapy_WT Population
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =0.9109
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter DCR difference (R-C)
Estimated Value -10.3
Confidence Interval (2-Sided) 95%
-27.5 to 6.9
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Progression-free Survival (PFS) - Central Assessment
Hide Description Progression free survival (PFS) was defined as the time (days) from randomization to date of first observed disease progression (radiological or clinical assessment or both) or death due to any cause (if death occurred before progression was documented).
Time Frame From start of treatment till end of active follow-up, approximately 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rogaratinib (BAY1163877)_Overall Population Chemotherapy_Overall Population Rogaratinib_WT Population Chemotherapy_WT Population
Hide Arm/Group Description:
Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Rogaratinib arm, Wild type population
Chemotherapy group, Wild type population
Overall Number of Participants Analyzed 87 88 62 63
Median (95% Confidence Interval)
Unit of Measure: months
2.7
(1.6 to 4.6)
3.2
(2.7 to 4.4)
2.8
(2.6 to 5.1)
4.0
(2.8 to 6.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Rogaratinib (BAY1163877)_Overall Population, Chemotherapy_Overall Population
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value = 0.8672
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.226
Confidence Interval (2-Sided) 95%
0.853 to 1.762
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Rogaratinib_WT Population, Chemotherapy_WT Population
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9171
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.341
Confidence Interval (2-Sided) 95%
0.880 to 2.043
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Duration of Response (DOR) - Central Assessment
Hide Description DOR (for patients with PR and CR only) was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression (including symptomatic deterioration) or death, whichever was earlier
Time Frame From start of treatment till end of active follow-up, approximately 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rogaratinib (BAY1163877)_Overall Population Chemotherapy_Overall Population Rogaratinib_WT Population Chemotherapy_WT Population
Hide Arm/Group Description:
Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Rogaratinib arm, Wild type population
Chemotherapy group, Wild type population
Overall Number of Participants Analyzed 87 88 62 63
Median (95% Confidence Interval)
Unit of Measure: months
4.9
(2.2 to 7.0)
5.8
(3.5 to 7.7)
5.1
(1.5 to 9.2)
7.0
(2.7 to 8.4)
5.Secondary Outcome
Title Number of Participants With Treatment Emergent Adverse Events
Hide Description A treatment-emergent event was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment
Time Frame From start of treatment up to 30 days after the last administration of study treatment, approximately 29 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Rogaratinib (BAY1163877) Chemotherapy
Hide Arm/Group Description:
Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle.
Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
Overall Number of Participants Analyzed 86 82
Measure Type: Count of Participants
Unit of Measure: Participants
Any TEAE
86
 100.0%
82
 100.0%
Any drug related TEAE
81
  94.2%
76
  92.7%
Time Frame Approximately 29 months
Adverse Event Reporting Description A treatment-emergent adverse event reported in this study was defined as any event arising or worsening after the start of study drug administration until 30 days after the last administration of study treatment.
 
Arm/Group Title Rogaratinib (BAY1163877) Chemotherapy
Hide Arm/Group Description Participants who were randomized to this group following a 1:1 ratio received rogaratinib 600 mg orally twice a day (b.i.d.) continuously, during a 21-day treatment cycle. Participants who were randomized to this group following a 1:1 ratio received chemotherapy (docetaxel, paclitaxel or vinflunine) at the discretion of the investigator, as intravenous (i.v.) infusion once every three weeks (on day 1 of a 21-day cycle).
All-Cause Mortality
Rogaratinib (BAY1163877) Chemotherapy
Affected / at Risk (%) Affected / at Risk (%)
Total   47/86 (54.65%)      45/82 (54.88%)    
Hide Serious Adverse Events
Rogaratinib (BAY1163877) Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/86 (45.35%)      33/82 (40.24%)    
Blood and lymphatic system disorders     
Anaemia * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Febrile neutropenia * 1  0/86 (0.00%)  0 4/82 (4.88%)  4
Neutropenia * 1  0/86 (0.00%)  0 4/82 (4.88%)  6
Thrombocytopenia * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Cardiac disorders     
Acute myocardial infarction * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Cardiopulmonary failure * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  3/86 (3.49%)  3 0/82 (0.00%)  0
Colitis ischaemic * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Diarrhoea * 1  0/86 (0.00%)  0 2/82 (2.44%)  2
Inguinal hernia * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Intestinal obstruction * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Intussusception * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Nausea * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Pancreatitis * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Small intestinal obstruction * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Volvulus * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Vomiting * 1  1/86 (1.16%)  1 1/82 (1.22%)  1
General disorders     
Asthenia * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Condition aggravated * 1  2/86 (2.33%)  2 0/82 (0.00%)  0
Death * 1  4/86 (4.65%)  4 2/82 (2.44%)  2
Mucosal inflammation * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Oedema peripheral * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Pain * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Pyrexia * 1  1/86 (1.16%)  1 1/82 (1.22%)  1
General physical health deterioration * 1  4/86 (4.65%)  6 1/82 (1.22%)  1
Multiple organ dysfunction syndrome * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Hepatobiliary disorders     
Cholecystitis * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Cholelithiasis * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Hepatic failure * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Infections and infestations     
Bronchitis * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Cellulitis * 1  1/86 (1.16%)  1 2/82 (2.44%)  2
Pneumonia * 1  0/86 (0.00%)  0 2/82 (2.44%)  2
Relapsing fever * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Sepsis * 1  0/86 (0.00%)  0 3/82 (3.66%)  3
Urinary tract infection * 1  1/86 (1.16%)  1 4/82 (4.88%)  4
Wound infection * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Urosepsis * 1  1/86 (1.16%)  1 2/82 (2.44%)  2
Groin infection * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Klebsiella infection * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Respiratory tract infection * 1  0/86 (0.00%)  0 1/82 (1.22%)  2
Device related infection * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Pneumocystis jirovecii pneumonia * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Escherichia pyelonephritis * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Injury, poisoning and procedural complications     
Fall * 1  1/86 (1.16%)  1 1/82 (1.22%)  1
Femoral neck fracture * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Hip fracture * 1  1/86 (1.16%)  2 0/82 (0.00%)  0
Periprosthetic fracture * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Investigations     
Aspartate aminotransferase increased * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Biopsy liver * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Blood creatinine increased * 1  2/86 (2.33%)  7 0/82 (0.00%)  0
Lipase increased * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Metabolism and nutrition disorders     
Dehydration * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Hypercalcaemia * 1  1/86 (1.16%)  2 0/82 (0.00%)  0
Hypomagnesaemia * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Decreased appetite * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Musculoskeletal and connective tissue disorders     
Back pain * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Musculoskeletal pain * 1  1/86 (1.16%)  2 0/82 (0.00%)  0
Osteonecrosis * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Pain in extremity * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Nervous system disorders     
Epilepsy * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Hepatic encephalopathy * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Neurotoxicity * 1  0/86 (0.00%)  0 1/82 (1.22%)  2
Peripheral sensory neuropathy * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Renal and urinary disorders     
Anuria * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Haematuria * 1  1/86 (1.16%)  1 3/82 (3.66%)  4
Hydronephrosis * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Nephritis * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Oliguria * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Haemorrhage urinary tract * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Postrenal failure * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Urinary tract obstruction * 1  1/86 (1.16%)  1 1/82 (1.22%)  1
Acute kidney injury * 1  3/86 (3.49%)  4 2/82 (2.44%)  2
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 1  3/86 (3.49%)  4 0/82 (0.00%)  0
Emphysema * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Interstitial lung disease * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
Pleural effusion * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Pneumonitis * 1  0/86 (0.00%)  0 1/82 (1.22%)  2
Pulmonary embolism * 1  0/86 (0.00%)  0 1/82 (1.22%)  1
Surgical and medical procedures     
Ureteral stent insertion * 1  1/86 (1.16%)  1 0/82 (0.00%)  0
1
Term from vocabulary, MedDRA 23.1
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Rogaratinib (BAY1163877) Chemotherapy
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   85/86 (98.84%)      77/82 (93.90%)    
Blood and lymphatic system disorders     
Anaemia * 1  11/86 (12.79%)  17 28/82 (34.15%)  66
Neutropenia * 1  3/86 (3.49%)  6 19/82 (23.17%)  30
Eye disorders     
Dry eye * 1  5/86 (5.81%)  5 3/82 (3.66%)  3
Detachment of retinal pigment epithelium * 1  7/86 (8.14%)  16 0/82 (0.00%)  0
Subretinal fluid * 1  7/86 (8.14%)  8 0/82 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain * 1  15/86 (17.44%)  18 13/82 (15.85%)  27
Constipation * 1  25/86 (29.07%)  31 29/82 (35.37%)  54
Diarrhoea * 1  48/86 (55.81%)  92 18/82 (21.95%)  19
Dry mouth * 1  10/86 (11.63%)  15 2/82 (2.44%)  2
Mouth ulceration * 1  5/86 (5.81%)  7 3/82 (3.66%)  3
Nausea * 1  27/86 (31.40%)  38 20/82 (24.39%)  38
Stomatitis * 1  10/86 (11.63%)  15 10/82 (12.20%)  14
Vomiting * 1  15/86 (17.44%)  19 18/82 (21.95%)  26
General disorders     
Asthenia * 1  25/86 (29.07%)  52 19/82 (23.17%)  40
Fatigue * 1  21/86 (24.42%)  32 28/82 (34.15%)  41
Mucosal inflammation * 1  7/86 (8.14%)  20 8/82 (9.76%)  12
Oedema peripheral * 1  8/86 (9.30%)  9 10/82 (12.20%)  13
Pyrexia * 1  12/86 (13.95%)  15 10/82 (12.20%)  14
Infections and infestations     
Conjunctivitis * 1  5/86 (5.81%)  8 3/82 (3.66%)  3
Influenza * 1  5/86 (5.81%)  5 0/82 (0.00%)  0
Paronychia * 1  7/86 (8.14%)  8 0/82 (0.00%)  0
Urinary tract infection * 1  12/86 (13.95%)  12 8/82 (9.76%)  13
Investigations     
Alanine aminotransferase increased * 1  13/86 (15.12%)  22 2/82 (2.44%)  4
Aspartate aminotransferase increased * 1  10/86 (11.63%)  16 2/82 (2.44%)  3
Blood creatinine increased * 1  11/86 (12.79%)  18 3/82 (3.66%)  6
Gamma-glutamyltransferase increased * 1  5/86 (5.81%)  6 0/82 (0.00%)  0
Lipase increased * 1  9/86 (10.47%)  25 3/82 (3.66%)  11
Neutrophil count decreased * 1  0/86 (0.00%)  0 14/82 (17.07%)  22
Weight decreased * 1  10/86 (11.63%)  11 6/82 (7.32%)  7
White blood cell count decreased * 1  0/86 (0.00%)  0 5/82 (6.10%)  5
Blood alkaline phosphatase increased * 1  12/86 (13.95%)  14 2/82 (2.44%)  3
Calcium phosphate product increased * 1  8/86 (9.30%)  10 0/82 (0.00%)  0
Metabolism and nutrition disorders     
Hyperkalaemia * 1  8/86 (9.30%)  11 6/82 (7.32%)  14
Hyperphosphataemia * 1  39/86 (45.35%)  79 0/82 (0.00%)  0
Hyponatraemia * 1  6/86 (6.98%)  9 5/82 (6.10%)  7
Decreased appetite * 1  36/86 (41.86%)  55 21/82 (25.61%)  25
Musculoskeletal and connective tissue disorders     
Arthralgia * 1  9/86 (10.47%)  12 7/82 (8.54%)  7
Back pain * 1  8/86 (9.30%)  8 8/82 (9.76%)  9
Myalgia * 1  5/86 (5.81%)  6 10/82 (12.20%)  12
Pain in extremity * 1  7/86 (8.14%)  10 4/82 (4.88%)  4
Nervous system disorders     
Dysgeusia * 1  13/86 (15.12%)  14 5/82 (6.10%)  6
Headache * 1  6/86 (6.98%)  7 4/82 (4.88%)  5
Neuropathy peripheral * 1  3/86 (3.49%)  4 10/82 (12.20%)  12
Peripheral sensory neuropathy * 1  1/86 (1.16%)  1 10/82 (12.20%)  14
Psychiatric disorders     
Insomnia * 1  5/86 (5.81%)  5 4/82 (4.88%)  4
Renal and urinary disorders     
Haematuria * 1  9/86 (10.47%)  13 6/82 (7.32%)  8
Respiratory, thoracic and mediastinal disorders     
Cough * 1  4/86 (4.65%)  6 6/82 (7.32%)  7
Dyspnoea * 1  3/86 (3.49%)  3 5/82 (6.10%)  6
Epistaxis * 1  10/86 (11.63%)  10 1/82 (1.22%)  1
Skin and subcutaneous tissue disorders     
Alopecia * 1  20/86 (23.26%)  23 24/82 (29.27%)  26
Dry skin * 1  7/86 (8.14%)  9 2/82 (2.44%)  2
Nail discolouration * 1  6/86 (6.98%)  8 0/82 (0.00%)  0
Palmar-plantar erythrodysaesthesia syndrome * 1  7/86 (8.14%)  10 0/82 (0.00%)  0
Rash * 1  7/86 (8.14%)  9 3/82 (3.66%)  5
Onychomadesis * 1  7/86 (8.14%)  8 0/82 (0.00%)  0
Nail toxicity * 1  7/86 (8.14%)  12 0/82 (0.00%)  0
Vascular disorders     
Hypotension * 1  6/86 (6.98%)  6 1/82 (1.22%)  1
1
Term from vocabulary, MedDRA 23.1
*
Indicates events were collected by non-systematic assessment
[Not Specified]
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
 
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Therapeutic Area Head
Organization: Bayer
Phone: (+) 1-888-8422937
EMail: clinical-trials-contact@bayer.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT03410693    
Other Study ID Numbers: 17403
2016-004340-11 ( EudraCT Number )
First Submitted: January 19, 2018
First Posted: January 25, 2018
Results First Submitted: October 13, 2021
Results First Posted: December 29, 2021
Last Update Posted: September 28, 2022