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Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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ClinicalTrials.gov Identifier: NCT01540565
Recruitment Status : Completed
First Posted : February 29, 2012
Results First Posted : March 19, 2019
Last Update Posted : July 23, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions BRCA1 Mutation Carrier
BRCA2 Mutation Carrier
Ovarian Epithelial Tumor
Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Other: Laboratory Biomarker Analysis
Drug: Veliparib
Enrollment 52
Recruitment Details Study opened to patient entry April 2012 and closed to accrual November 2012.
Pre-assignment Details  
Arm/Group Title Treatment (Veliparib)
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Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

Period Title: Overall Study
Started 52
Completed 50
Not Completed 2
Reason Not Completed
Ineligible             2
Arm/Group Title Treatment (Veliparib)
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Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
20-29 years
0
   0.0%
30-39 years
2
   4.0%
40-49 years
15
  30.0%
50-59 years
14
  28.0%
60-69 years
15
  30.0%
70-79 years
2
   4.0%
>=80 years
2
   4.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
50
 100.0%
Male
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   4.0%
White
44
  88.0%
More than one race
0
   0.0%
Unknown or Not Reported
3
   6.0%
Cell Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Serous
41
  82.0%
Other
9
  18.0%
1.Primary Outcome
Title Proportion of Patients With Complete and Partial Tumor Response
Hide Description Patients with complete and partial tumor response by RECIST V1.1 (per response evaluation criteria in Solid Tumors Criteria (RECIST V1.1) for target lesions and assessed by MRI (CT scan): Complete Response (CR), disappearance of all target lesions (confirmed at >= 4 weeks); Partial Response (PR) >= 30% decrease in the sum of the longest diameter of target lesions (confirmed at >= 4 weeks); Overall Response = CR + PR.
Time Frame CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Repeat at other times if clinically indicated.Responses require confirmation at >= 4 wks from first documentation.
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Hide Analysis Population Description
Eligible and evaluable
Arm/Group Title Treatment (Veliparib)
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Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of patients
0.26
(0.146 to 0.403)
2.Primary Outcome
Title Proportion of Patients With Adverse Events as Assessed by CTCAE v4.0
Hide Description Patients with grade 3 or greater Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported.
Time Frame After every cycle while on study therapy. Followed for late adverse events up to 30 days after completing therapy.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable
Arm/Group Title Treatment (Veliparib)
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Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of patients
0.32
(0.195 to 0.467)
3.Secondary Outcome
Title Duration of PFS
Hide Description The time from randomization until disease progression, death, or date of last contact. Endpoints are progression or death. Patients who are not observed with an endpoint are censored. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (and >= 5 mm increase of target lesions), or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame CT scan/MRI if used to follow lesion for measurable disease every other cycle for the first 6 months, then every 3 months until progression. Patients who begin subsequent therapy without progression will be monitored for PFS for 5 years.
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Hide Analysis Population Description
Eligible and evaluable
Arm/Group Title Treatment (Veliparib)
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Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

Overall Number of Participants Analyzed 50
Median (90% Confidence Interval)
Unit of Measure: months
8.18
(5.45 to 9.63)
4.Secondary Outcome
Title Duration of OS
Hide Description Overall survival
Time Frame Every cycle while patient is receiving protocol therapy. Patients will be monitored for survival after going off therapy for a 5 year period, every 3 months for the first 2 years, then every 6 months for the last 3 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable
Arm/Group Title Treatment (Veliparib)
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Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

Overall Number of Participants Analyzed 50
Median (Inter-Quartile Range)
Unit of Measure: Months
NA [1] 
(13.4 to NA)
[1]
The sample size was not sufficient for the calculation of the median. The first quartile of 13.4 months was calculated, but the data was not adequate for the computation of the median or the third quartile.
5.Secondary Outcome
Title The Proportion of Patients Who Survive Progression-free for at Least 6 Months
Hide Description This outcome captures whether or not the patient survived progression-free for at least 6 months, and is displayed as a proportion.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and evaluable
Arm/Group Title Treatment (Veliparib)
Hide Arm/Group Description:

Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Proportion of patients
0.54
(0.393 to 0.682)
6.Other Pre-specified Outcome
Title SNPs With DNA Repair Genes, Tumor Response, PFS, OS, and Patient Demographics (e.g. Age, Race, Tumor Grade)
Hide Description If the clinical trial goes to the second stage and there is sufficient variability in the SNPs, then patients can be categorized by the nature of their SNPs and assessed for prognostic value through survival analysis (e.g. log-rank tests and Cox proportional hazards modeling). If the variability in SNPs is relatively low, assessment of prognostic value can be conducted with odds ratios of patients responding or surviving progression-free for at least 6 months. These techniques will use exact methods such as Fisher’s exact test.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Treatment (Veliparib)
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Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
7.Other Pre-specified Outcome
Title BRCA Mutation in Primary Tumor Tissue
Hide Description BRCA mutational status will be tabulated against the germline mutation to see what proportion of patients have a mutation reversal within the tumor and whether such reversals can explain resistance to the regimen under study.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Treatment (Veliparib)
Hide Arm/Group Description:

Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame Adverse events are collected from study enrollment until 30 days after the last treatment, up to 5 years from enrollment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Veliparib)
Hide Arm/Group Description

Patients receive veliparib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis: Correlative studies

Veliparib: Given PO

All-Cause Mortality
Treatment (Veliparib)
Affected / at Risk (%)
Total   21/50 (42.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Veliparib)
Affected / at Risk (%)
Total   10/50 (20.00%) 
Gastrointestinal disorders   
Small Intestinal Obstruction * 1  3/50 (6.00%) 
Abdominal Pain * 1  1/50 (2.00%) 
Nausea * 1  1/50 (2.00%) 
Ascites * 1  1/50 (2.00%) 
Hepatobiliary disorders   
Hepatobiliary Disorders - Other * 1  1/50 (2.00%) 
Investigations   
Alanine Aminotransferase Increased * 1  1/50 (2.00%) 
Metabolism and nutrition disorders   
Dehydration * 1  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Pleural Effusion * 1  1/50 (2.00%) 
Adult Respiratory Distress Syndrome * 1  1/50 (2.00%) 
Vascular disorders   
Thromboembolic Event * 1  1/50 (2.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Veliparib)
Affected / at Risk (%)
Total   48/50 (96.00%) 
Blood and lymphatic system disorders   
Anemia * 1  29/50 (58.00%) 
Cardiac disorders   
Palpitations * 1  1/50 (2.00%) 
Heart Failure * 1  1/50 (2.00%) 
Paroxysmal Atrial Tachycardia * 1  1/50 (2.00%) 
Sinus Tachycardia * 1  1/50 (2.00%) 
Ear and labyrinth disorders   
Vertigo * 1  3/50 (6.00%) 
Tinnitus * 1  4/50 (8.00%) 
Hearing Impaired * 1  1/50 (2.00%) 
Eye disorders   
Watering Eyes * 1  2/50 (4.00%) 
Conjunctivitis * 1  1/50 (2.00%) 
Blurred Vision * 1  3/50 (6.00%) 
Gastrointestinal disorders   
Dyspepsia * 1  4/50 (8.00%) 
Dry Mouth * 1  4/50 (8.00%) 
Colonic Perforation * 1  1/50 (2.00%) 
Colonic Fistula * 1  1/50 (2.00%) 
Constipation * 1  20/50 (40.00%) 
Diarrhea * 1  16/50 (32.00%) 
Vomiting * 1  33/50 (66.00%) 
Bloating * 1  8/50 (16.00%) 
Stomach Pain * 1  4/50 (8.00%) 
Small Intestinal Obstruction * 1  2/50 (4.00%) 
Abdominal Pain * 1  15/50 (30.00%) 
Periodontal Disease * 1  1/50 (2.00%) 
Rectal Hemorrhage * 1  1/50 (2.00%) 
Mucositis Oral * 1  3/50 (6.00%) 
Abdominal Distension * 1  2/50 (4.00%) 
Nausea * 1  45/50 (90.00%) 
Gastroesophageal Reflux Disease * 1  4/50 (8.00%) 
Hemorrhoids * 1  2/50 (4.00%) 
Flatulence * 1  4/50 (8.00%) 
Gastritis * 1  2/50 (4.00%) 
General disorders   
Pain * 1  5/50 (10.00%) 
Malaise * 1  4/50 (8.00%) 
Flu Like Symptoms * 1  6/50 (12.00%) 
Edema Trunk * 1  2/50 (4.00%) 
Non-Cardiac Chest Pain * 1  4/50 (8.00%) 
Edema Limbs * 1  2/50 (4.00%) 
Fatigue * 1  35/50 (70.00%) 
Fever * 1  2/50 (4.00%) 
Chills * 1  2/50 (4.00%) 
Infections and infestations   
Sepsis * 1  1/50 (2.00%) 
Urinary Tract Infection * 1  5/50 (10.00%) 
Enterocolitis Infectious * 1  1/50 (2.00%) 
Injury, poisoning and procedural complications   
Gastrointestinal Anastomotic Leak * 1  1/50 (2.00%) 
Fracture * 1  1/50 (2.00%) 
Fall * 1  2/50 (4.00%) 
Ankle Fracture * 1  1/50 (2.00%) 
Investigations   
Weight Loss * 1  2/50 (4.00%) 
Weight Gain * 1  4/50 (8.00%) 
Platelet Count Decreased * 1  10/50 (20.00%) 
Lymphocyte Count Decreased * 1  8/50 (16.00%) 
Creatinine Increased * 1  3/50 (6.00%) 
Neutrophil Count Decreased * 1  18/50 (36.00%) 
Blood Bilirubin Increased * 1  3/50 (6.00%) 
White Blood Cell Decreased * 1  25/50 (50.00%) 
Aspartate Aminotransferase Increased * 1  8/50 (16.00%) 
Alkaline Phosphatase Increased * 1  9/50 (18.00%) 
Alanine Aminotransferase Increased * 1  9/50 (18.00%) 
Activated Partial Thromboplastin Time Prolonged * 1  1/50 (2.00%) 
Metabolism and nutrition disorders   
Hypophosphatemia * 1  5/50 (10.00%) 
Hyponatremia * 1  11/50 (22.00%) 
Hypomagnesemia * 1  15/50 (30.00%) 
Hypokalemia * 1  10/50 (20.00%) 
Hypoglycemia * 1  1/50 (2.00%) 
Hypocalcemia * 1  10/50 (20.00%) 
Hypoalbuminemia * 1  7/50 (14.00%) 
Hyperuricemia * 1  1/50 (2.00%) 
Hypermagnesemia * 1  1/50 (2.00%) 
Hyperkalemia * 1  2/50 (4.00%) 
Hyperglycemia * 1  10/50 (20.00%) 
Hypercalcemia * 1  1/50 (2.00%) 
Glucose Intolerance * 1  1/50 (2.00%) 
Dehydration * 1  1/50 (2.00%) 
Anorexia * 1  12/50 (24.00%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  3/50 (6.00%) 
Myalgia * 1  6/50 (12.00%) 
Muscle Weakness Upper Limb * 1  1/50 (2.00%) 
Muscle Weakness Lower Limb * 1  1/50 (2.00%) 
Generalized Muscle Weakness * 1  4/50 (8.00%) 
Chest Wall Pain * 1  1/50 (2.00%) 
Bone Pain * 1  4/50 (8.00%) 
Back Pain * 1  5/50 (10.00%) 
Arthralgia * 1  5/50 (10.00%) 
Nervous system disorders   
Tremor * 1  1/50 (2.00%) 
Somnolence * 1  1/50 (2.00%) 
Peripheral Sensory Neuropathy * 1  14/50 (28.00%) 
Paresthesia * 1  1/50 (2.00%) 
Memory Impairment * 1  3/50 (6.00%) 
Movements Involuntary * 1  2/50 (4.00%) 
Headache * 1  14/50 (28.00%) 
Dysgeusia * 1  5/50 (10.00%) 
Syncope * 1  1/50 (2.00%) 
Dizziness * 1  13/50 (26.00%) 
Depressed Level Of Consciousness * 1  1/50 (2.00%) 
Concentration Impairment * 1  1/50 (2.00%) 
Cognitive Disturbance * 1  1/50 (2.00%) 
Psychiatric disorders   
Restlessness * 1  1/50 (2.00%) 
Insomnia * 1  13/50 (26.00%) 
Depression * 1  7/50 (14.00%) 
Confusion * 1  1/50 (2.00%) 
Anxiety * 1  12/50 (24.00%) 
Agitation * 1  2/50 (4.00%) 
Renal and urinary disorders   
Urinary Incontinence * 1  1/50 (2.00%) 
Urinary Frequency * 1  1/50 (2.00%) 
Proteinuria * 1  2/50 (4.00%) 
Chronic Kidney Disease * 1  1/50 (2.00%) 
Reproductive system and breast disorders   
Pelvic Pain * 1  2/50 (4.00%) 
Vaginal Discharge * 1  1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders   
Sore Throat * 1  2/50 (4.00%) 
Pulmonary Edema * 1  1/50 (2.00%) 
Postnasal Drip * 1  2/50 (4.00%) 
Pleural Effusion * 1  3/50 (6.00%) 
Nasal Congestion * 1  3/50 (6.00%) 
Pharyngeal Stenosis * 1  1/50 (2.00%) 
Hypoxia * 1  1/50 (2.00%) 
Hoarseness * 1  1/50 (2.00%) 
Epistaxis * 1  2/50 (4.00%) 
Dyspnea * 1  1/50 (2.00%) 
Cough * 1  5/50 (10.00%) 
Atelectasis * 1  1/50 (2.00%) 
Allergic Rhinitis * 1  2/50 (4.00%) 
Skin and subcutaneous tissue disorders   
Skin Hyperpigmentation * 1  1/50 (2.00%) 
Rash Acneiform * 1  1/50 (2.00%) 
Pruritus * 1  1/50 (2.00%) 
Rash Maculo-Papular * 1  6/50 (12.00%) 
Nail Discoloration * 1  1/50 (2.00%) 
Dry Skin * 1  1/50 (2.00%) 
Alopecia * 1  5/50 (10.00%) 
Vascular disorders   
Lymphedema * 1  1/50 (2.00%) 
Hypotension * 1  1/50 (2.00%) 
Hypertension * 1  6/50 (12.00%) 
Hot Flashes * 1  6/50 (12.00%) 
Flushing * 1  1/50 (2.00%) 
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
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: Christopher Purdy on behalf of Mike Sill
Organization: NRG Oncology
Phone: (716)845-1300 ext 2296
EMail: purdyc@nrgoncology.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01540565     History of Changes
Other Study ID Numbers: NCI-2012-00684
NCI-2012-00684 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S12-02446
GOG-0280
CDR0000726699
GOG-0280 ( Other Identifier: NRG Oncology )
GOG-0280 ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: February 22, 2012
First Posted: February 29, 2012
Results First Submitted: January 23, 2019
Results First Posted: March 19, 2019
Last Update Posted: July 23, 2019