Phase 1b/2 Safety and Efficacy of APR-246 w/Azacitidine for tx of TP53 Mutant Myeloid Neoplasms
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ClinicalTrials.gov Identifier: NCT03072043 |
Recruitment Status :
Completed
First Posted : March 7, 2017
Results First Posted : February 25, 2021
Last Update Posted : January 24, 2022
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Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
Aprea Therapeutics
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
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Study Type | Interventional |
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Study Design | Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Conditions |
Myelodysplastic Syndrome Acute Myeloid Leukemia Myeloproliferative Neoplasm Chronic Myelomonocytic Leukemia |
Interventions |
Drug: APR-246 Drug: Azacitidine |
Enrollment | 55 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Phase 1b Dose Level 1 | Phase 1B Dose Level 2 | Phase 1B Dose Level 3 / Phase 2 MTD |
---|---|---|---|
Arm/Group Description | Participants treated at level 1: APR-246 50mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2 | Participants treated at dose level 2: APR-246 75mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2 | Participants treated at dose level 3/Phase 2 MTD : APR-246 100 mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2 |
Period Title: Overall Study | |||
Started | 3 | 3 | 49 |
Completed | 3 | 3 | 40 |
Not Completed | 0 | 0 | 9 |
Reason Not Completed | |||
Death | 0 | 0 | 3 |
Adverse Event | 0 | 0 | 2 |
Withdrawal by Subject | 0 | 0 | 4 |
Baseline Characteristics
Arm/Group Title | Phase 1B Dose Level 1 | Phase 1B Dos Level 2 | Phase 1B Dose Level 3/ MTD | Total | |
---|---|---|---|---|---|
Arm/Group Description | Participants treated at level 1: APR-246 50mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2 | Participants treated at dose level 2: APR-246 75mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2 | Participants treated at dose level 3/MTD : APR-246 100 mg/kg lean body weight (LBW) + Azacitidine 75mg/m^2 | Total of all reporting groups | |
Overall Number of Baseline Participants | 3 | 3 | 49 | 55 | |
Baseline Analysis Population Description |
[Not Specified]
|
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 3 participants | 3 participants | 49 participants | 55 participants | |
<=18 years |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Between 18 and 65 years |
1 33.3%
|
1 33.3%
|
20 40.8%
|
22 40.0%
|
|
>=65 years |
2 66.7%
|
2 66.7%
|
29 59.2%
|
33 60.0%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 3 participants | 3 participants | 49 participants | 55 participants | |
Female |
2 66.7%
|
3 100.0%
|
24 49.0%
|
29 52.7%
|
|
Male |
1 33.3%
|
0 0.0%
|
25 51.0%
|
26 47.3%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 3 participants | 3 participants | 49 participants | 55 participants | |
Hispanic or Latino |
0 0.0%
|
2 66.7%
|
2 4.1%
|
4 7.3%
|
|
Not Hispanic or Latino |
3 100.0%
|
1 33.3%
|
45 91.8%
|
49 89.1%
|
|
Unknown or Not Reported |
0 0.0%
|
0 0.0%
|
2 4.1%
|
2 3.6%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
|||||
Number Analyzed | 3 participants | 3 participants | 49 participants | 55 participants | |
American Indian or Alaska Native |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Asian |
0 0.0%
|
0 0.0%
|
2 4.1%
|
2 3.6%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
0 0.0%
|
0 0.0%
|
2 4.1%
|
2 3.6%
|
|
White |
2 66.7%
|
3 100.0%
|
42 85.7%
|
47 85.5%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
1 33.3%
|
0 0.0%
|
3 6.1%
|
4 7.3%
|
|
Region of Enrollment
Measure Type: Number Unit of measure: Participants |
|||||
United States | Number Analyzed | 3 participants | 3 participants | 49 participants | 55 participants |
3 | 3 | 49 | 55 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | David Sallman, MD |
Organization: | Moffitt Cancer Center |
Phone: | 813-745-6841 |
EMail: | David.Sallman@moffitt.org |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT03072043 |
Other Study ID Numbers: |
MCC-18973 |
First Submitted: | March 2, 2017 |
First Posted: | March 7, 2017 |
Results First Submitted: | November 13, 2020 |
Results First Posted: | February 25, 2021 |
Last Update Posted: | January 24, 2022 |