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BMN 673 (Talazoparib), an Oral PARP Inhibitor, in People With Deleterious BRCA1/2 Mutation-Associated Ovarian Cancer Who Have Had Prior PARP Inhibitor Treatment

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ClinicalTrials.gov Identifier: NCT02326844
Recruitment Status : Terminated (Study was closed by the Cancer Therapy Evaluation Program (CTEP))
First Posted : December 30, 2014
Results First Posted : May 24, 2017
Last Update Posted : August 27, 2018
Sponsor:
Information provided by (Responsible Party):
Jung-Min Lee, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ovarian Cancer
Intervention Drug: BMN 673 (talazoparib)
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ovarian Cancer Patients
Hide Arm/Group Description Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Ovarian Cancer Patients
Hide Arm/Group Description Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants
51.1  (3.45)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
3
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
3
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
  33.3%
White
2
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 3 participants
3
1.Primary Outcome
Title Objective Response (Complete Response (CR) + Partial Response (PR))
Hide Description Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Time Frame Every 2 cycles, an average of 64 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ovarian Cancer Patients
Hide Arm/Group Description:
Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events
Hide Description Here is the number participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events v4.0. For a detailed list of events, see the adverse event module.
Time Frame 15 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ovarian Cancer Patients
Hide Arm/Group Description:
Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
Overall Number of Participants Analyzed 3
Measure Type: Count of Participants
Unit of Measure: Participants
3
 100.0%
3.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is the time between study enrollment and off-treatment date.
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ovarian Cancer Patients
Hide Arm/Group Description:
Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
Overall Number of Participants Analyzed 3
Median (Full Range)
Unit of Measure: months
2
(1 to 3)
4.Secondary Outcome
Title Progression Free Survival (PFS) on BMN673 (Talazoparib) to PFS From First Poly (ADP-ribose) Polymerase Inhibitor (PARPPi) Exposure
Hide Description The median time to progression after receiving BMN673 will be compared informally to the time of progression for the same patients after receiving an initial PARPi exposure. Progression is at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more lesions is also considered progressions).
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not done because the study was prematurely closed by the Cancer Therapy Evaluation Program (CTEP) sponsor following the enrollment of 3 subjects. We were unable to analyze biomarker endpoints due to insufficient number of samples after premature closure of the study.
Arm/Group Title Ovarian Cancer Patients
Hide Arm/Group Description:
Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Other Pre-specified Outcome
Title Forkhead Box 03 (FOXO3a), p53-binding Protein 1 (53BP1) and RAD51 (i.e., Eukaryote Gene) Biomarkers
Hide Description Patients will undergo a mandatory biopsy at baseline and reverse phase protein microarray (RPPA)26 testing will be performed to determine the potential predictive biomarkers of subsequent poly (adenosine diphosphate [ADP]) ribose polymerase inhibitors (PARPi ) response.
Time Frame Baseline
Outcome Measure Data Not Reported
6.Other Pre-specified Outcome
Title Secondary Mutation of Breast Cancer 1 (BRCA1) and Breast Cancer 2 (BRCA2)
Hide Description Patients will undergo a mandatory biopsy at baseline and Next Generation Sequencing to elucidate the secondary mutations of BRCA1 and BRCA2 will be performed.
Time Frame Baseline
Outcome Measure Data Not Reported
Time Frame 15 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ovarian Cancer Patients
Hide Arm/Group Description Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
All-Cause Mortality
Ovarian Cancer Patients
Affected / at Risk (%)
Total   0/3 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ovarian Cancer Patients
Affected / at Risk (%) # Events
Total   1/3 (33.33%)    
Investigations   
Platelet Count Decreased  1  1/3 (33.33%)  5
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ovarian Cancer Patients
Affected / at Risk (%) # Events
Total   2/3 (66.67%)    
Blood and lymphatic system disorders   
Anemia  1  2/3 (66.67%)  6
Gastrointestinal disorders   
Constipation  1  1/3 (33.33%)  1
Nausea  1  1/3 (33.33%)  1
General disorders   
Fatigue  1  2/3 (66.67%)  2
Investigations   
Creatinine increased  1  1/3 (33.33%)  1
Lymphocyte count decreased  1  1/3 (33.33%)  2
Platelet count decreased  1  1/3 (33.33%)  5
White blood cell decreased  1  1/3 (33.33%)  4
Metabolism and nutrition disorders   
Hypophosphatemia  1  1/3 (33.33%)  1
Nervous system disorders   
Dizziness  1  1/3 (33.33%)  1
Renal and urinary disorders   
Urinary frequency  1  1/3 (33.33%)  1
Respiratory, thoracic and mediastinal disorders   
Hyperhidrosis  1  1/3 (33.33%)  1
Vascular disorders   
Vascular disorders - Other, bleeding gums  1  1/3 (33.33%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Dr. Jung-Min Lee
Organization: National Cancer Institute
Phone: 301-443-7735
Responsible Party: Jung-Min Lee, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT02326844     History of Changes
Other Study ID Numbers: 150050
15-C-0050
First Submitted: December 25, 2014
First Posted: December 30, 2014
Results First Submitted: January 12, 2017
Results First Posted: May 24, 2017
Last Update Posted: August 27, 2018