BRCA germline mutational and Platinum-Resistant or Partially Platinum-Sensitive Recurrent Epithelial Ovarian Cancer. MedDRA version: 14.0 Level: LLT Classification code 10033130 Term: Ovarian cancer NOS System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Veliparib (ABT888)
Pharmaceutical Form: Capsule
INN or Proposed INN: ABT-888
Concentration unit: mg milligram(s)
Concentration type: range
Concentration number: 10-100
Sponsors
Vejle Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Stage I-IV. 2. Patients with known germline BRCA1/2 mutations 3. Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment. 4. Platinum resistance or partially platinum sensitive disease - Relapsed within six months of prior first line/later lines of platinum-based therapy or - Relapsed within six to twelve months of prior first line/later lines of platinum-based therapy 5. Age = 18 years. 6. Performance status 0-2. 7. Measurable disease by RECIST 1.1 or evaluable by CA125 GCIG criteria 8. Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to enrollment): WBC = 3.0 x 10^9/l or neutrophils (ANC) = 1.5 x 10^9/l Platelet count = 100 x 10^9/l Hemoglobin = 9.7 g/dl (6 mmol/L) Serum bilirubin = 1.5 x ULN Serum transaminases = 2.5 x ULN Serum creatinine = 1.5 x ULN 9. Written informed consent. 10. Tissue available for BRCAness analysis Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 33 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Prior treatment with a PARP inhibitor. 2. Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy) 3. Patients who have received (or are planning to receive) treatment with any other investigational agent, or who have participated in another clinical trial within 28 days prior to entering this trial. 4. Pregnant or breast-feeding women. For fertile women a negative pregnancy test at screening is mandatory. 5. Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment 6. Other present or previous malignancy except curatively treated cervical cancer stage I, non-melanotic skin cancer or other cancer with minimal risk of relapse. Curatively treated prior breast cancer is allowed, if no relapse is suspected at time of inclusion. 7. CNS metastasis. 8. History of any chronic medical or psychiatric condition or laboratory abnormality that is not medically controlled or in the opinion of the Investigator may increase the risks associated with study drug administration (e.g. diabetes, cardiac diseases, hypertension, renal or liver disease). 9. Allergy to the ingredients of the study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Phase I: To determine: • Maximum-tolerated dose (MTD) • Dose-limiting toxicities (DLT) • Recommended phase II dose Phase II: To investigate the response rate in platinum-resistant and partially platinum sensitive ovarian cancer patients with known BRCA mutations treated with veliparib monotherapy.;Secondary Objective: To investigate the clinical safety and toxicity as assessed by NCI CTCAE v4.0 Furthermore, to investigate the PFS and OS in BRCA1/2 positive ovarian cancer patients treated with veliparib. ;Primary end point(s): - Toxicity - Response rates;Timepoint(s) of evaluation of this end point: Every three treatment cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression Free Survival (PFS) • Overall survival (OS) • Toxicity;Timepoint(s) of evaluation of this end point: Every three treatment cycles | — |
Countries
Denmark
Outcome results
None listed