An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination with Chemotherapy in Subjects with Solid Tumors
- Conditions
- CancerSolid tumors10027655
- Registration Number
- NL-OMON40491
- Lead Sponsor
- AbbVie b.v.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
A subject will be eligible for study participation if he/she meets the following criteria:
1. Subject must be >= 18 years of age.
2. Subject has histologically or cytologically confirmed solid malignancy that is metastatic or unresectable and for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
4. Subject is appropriate for treatment with veliparib monotherapy (should have tumor with defects in DNA repair mechanisms (i.e., BRCA mutated breast cancer or high grade ovarian cancer with or without BRCA mutation), or veliparib in combination with carboplatin/paclitaxel or in combination with FOLFIRI (all subjects with advanced solid tumors are eligible for combination treatment).
5. Subjects with known brain metastases must have clinically controlled neurologic symptoms.
6. Subject has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 - 1.
7. Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range as follows:
* Bone marrow: Absolute Neutrophil count (ANC) >= 1,500/µL; Platelets >= 100,000/mm3; (independent of platelet transfusions within 3 months prior to starting study drug); Hemoglobin >= 9.0 g/dL;
* Renal function: serum creatinine <= 2.0 mg/dL or calculated creatinine clearance >= 50 mL/min;
* Hepatic function and enzymes: AST and ALT <= 2.5 × the upper limit of normal (ULN) of institution's normal range; Bilirubin <= 1.5 × ULN. Subjects with liver metastases may have an AST and ALT of <= 5.0 × ULN.
* Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics
Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of and screening for
study-specific procedures.
A subject will not be eligible for study participation if he/she meets any of the following criteria:
1. If the subject has clinically significant and uncontrolled major medical condition(s) including but not limited to:
* Uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months;
* Uncontrolled nausea/vomiting/diarrhea;
* Active uncontrolled infection;
* Symptomatic congestive heart failure;
* Unstable angina pectoris or cardiac arrhythmia;
* Psychiatric illness/social situation that would limit compliance with study requirements;
* Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.
2. Subjects who have previously experienced a hypersensitivity reaction to either carboplatin or cremophor/paclitaxel should be excluded from enrollment in Arm B.
4. Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug:
* Chemotherapy, immunotherapy, radiotherapy
* Any investigational therapy, including targeted small molecule agents, with the following exceptions:
* Hormonal anticancer therapy must be stopped 7 days before starting C1D1,
* Hormones for hypothyroidism, estrogen replacement therapy (ERT), or agonists required to suppress serum testosterone or estrogen levels (e.g., LHRH, GnRH, etc.) for subjects with prostate, breast and ovarian cancer if on a stable dose for 21 days prior to the first dose of study drug.
* Subject may have received a veliparib regimen any time prior to C1D1.
5. Subject has received a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.
6. Subject who requires parenteral nutrition, tube feeding or has evidence of partial bowel obstruction or perforation within 28 days prior to study drug administration.
7. The subject has had another active malignancy within the past 3 years except for any cancer in situ that the Principal Investigator considers to be cured.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Efficacy:<br /><br>The efficacy endpoints are objective response rate (ORR),<br /><br>time-to-disease-progression (TTP),<br /><br>progression-free-survival (PFS), and overall survival (OS). Radiographic<br /><br>results will be evaluated<br /><br>through the application of response evaluation criteria in solid tumors<br /><br>(RECIST) 1.1.<br /><br>Safety:<br /><br>Adverse events, laboratory profiles, physical examinations, vital signs will be<br /><br>evaluated throughout the<br /><br>study. The Medical Dictionary for Regulatory Activities (MedDRA) will be used<br /><br>with adverse event<br /><br>reports. NCI CTCAE 4.0 criteria will be applied to adverse event reports and<br /><br>laboratory variable values.<br /><br>All subjects treated with veliparib will be included in the summaries.</p><br>
- Secondary Outcome Measures
Name Time Method <p>NA</p><br>