VTX-2337 and Pegylated Liposomal Doxorubicin (PLD) in Patients With Recurrent or Persistent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01666444 |
Recruitment Status :
Completed
First Posted : August 16, 2012
Results First Posted : September 26, 2019
Last Update Posted : September 26, 2019
|
Sponsor:
Celgene
Collaborator:
Gynecologic Oncology Group
Information provided by (Responsible Party):
Celgene
- Study Details
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
Study Type | Interventional |
---|---|
Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Conditions |
Epithelial Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cancer |
Interventions |
Drug: pegylated liposomal doxorubicin (PLD) Drug: VTX-2337 Drug: Placebo |
Enrollment | 297 |
Participant Flow
Recruitment Details | Enrollment was initiated on 2012-Aug-13 and terminated on 2014-Apr-11. During this time, 297 patients were enrolled. |
Pre-assignment Details | Prior to enrollment and treatment assignment, a completed eligibility checklist was electronically checked for completeness and compliance with eligibility criteria. Prior to treatment assignment, patients were stratified by prior platinum free interval (<6 months or >6-12 months) and performance status (0 or 1). Treatments were double-blinded. |
Arm/Group Title | Pegylated Liposomal Doxorubicin (PLD) + Placebo | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) |
---|---|---|
Arm/Group Description | Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo | Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2 |
Period Title: Overall Study | ||
Started | 149 | 148 |
Completed | 147 | 147 |
Not Completed | 2 | 1 |
Reason Not Completed | ||
Did not initiate treatment | 2 | 1 |
Baseline Characteristics
Arm/Group Title | Pegylated Liposomal Doxorubicin (PLD) + Placebo | Pegylated Liposomal Doxorubicin (PLD)+VTX-2337 (VTX) | Total | |
---|---|---|---|---|
Arm/Group Description | Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus placebo | Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 plus VTX-2337 3.0 mg/m2 | Total of all reporting groups | |
Overall Number of Baseline Participants | 149 | 148 | 297 | |
Baseline Analysis Population Description |
All enrolled patients
|
|||
Age, Continuous
Median (Full Range) Unit of measure: Years |
||||
Number Analyzed | 149 participants | 148 participants | 297 participants | |
61.6
(29.7 to 91.1)
|
63.5
(39.6 to 84.8)
|
62.7
(29.7 to 91.1)
|
||
Age, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 149 participants | 148 participants | 297 participants |
<40 years |
4 2.7%
|
1 0.7%
|
5 1.7%
|
|
40-49 years |
22 14.8%
|
11 7.4%
|
33 11.1%
|
|
50-59 years |
39 26.2%
|
42 28.4%
|
81 27.3%
|
|
60-69 years |
50 33.6%
|
51 34.5%
|
101 34.0%
|
|
70-79 years |
31 20.8%
|
38 25.7%
|
69 23.2%
|
|
> 79 years |
3 2.0%
|
5 3.4%
|
8 2.7%
|
|
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 149 participants | 148 participants | 297 participants | |
Female |
149 100.0%
|
148 100.0%
|
297 100.0%
|
|
Male |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 149 participants | 148 participants | 297 participants | |
Hispanic or Latino |
4 2.7%
|
3 2.0%
|
7 2.4%
|
|
Not Hispanic or Latino |
143 96.0%
|
145 98.0%
|
288 97.0%
|
|
Unknown or Not Reported |
2 1.3%
|
0 0.0%
|
2 0.7%
|
|
Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 149 participants | 148 participants | 297 participants | |
American Indian or Alaska Native |
1 0.7%
|
1 0.7%
|
2 0.7%
|
|
Asian |
3 2.0%
|
3 2.0%
|
6 2.0%
|
|
Native Hawaiian or Other Pacific Islander |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Black or African American |
4 2.7%
|
6 4.1%
|
10 3.4%
|
|
White |
141 94.6%
|
137 92.6%
|
278 93.6%
|
|
More than one race |
0 0.0%
|
0 0.0%
|
0 0.0%
|
|
Unknown or Not Reported |
0 0.0%
|
1 0.7%
|
1 0.3%
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 149 participants | 148 participants | 297 participants | |
0 = Fully active, no restrictions |
104 69.8%
|
105 70.9%
|
209 70.4%
|
|
1=Restricted activity;ambulatory;can do light work |
45 30.2%
|
43 29.1%
|
88 29.6%
|
|
[1]
Measure Description:
ECOG performance status is used to describe a patient's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The scale ranges from 0 to 5: 0 = Fully active, no restrictions;
|
||||
Prior Platinum-Free Interval as per Case Report Forms
Measure Type: Count of Participants Unit of measure: Participants |
||||
Number Analyzed | 149 participants | 148 participants | 297 participants | |
<= 6 months |
79 53.0%
|
72 48.6%
|
151 50.8%
|
|
> 6 months |
70 47.0%
|
76 51.4%
|
146 49.2%
|
|
Prior Chemotherapy Regimens
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 149 participants | 148 participants | 297 participants |
1 |
81 54.4%
|
69 46.6%
|
150 50.5%
|
|
2 |
64 43.0%
|
74 50.0%
|
138 46.5%
|
|
3 |
4 2.7%
|
5 3.4%
|
9 3.0%
|
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Kristi Manjarrez |
Organization: | Vice President, Clinical Affairs |
Phone: | 206-689-2256 |
EMail: | kmanjarrez@ventirx.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Celgene |
ClinicalTrials.gov Identifier: | NCT01666444 |
Other Study ID Numbers: |
GOG-3003 |
First Submitted: | August 10, 2012 |
First Posted: | August 16, 2012 |
Results First Submitted: | March 5, 2017 |
Results First Posted: | September 26, 2019 |
Last Update Posted: | September 26, 2019 |