Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status

Ovarian Cancer Clinical Trial

Official title:

Veliparib (ABT888) and Topotecan (Hycamtin®) for Patients With Platinum-Resistant or Partially Platinum-Sensitive Relapse of Epithelial Ovarian Cancer With Negative or Unknown BRCA Status

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01690598
• Other study ID #: VeTo
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 17, 2012
• Last updated: June 9, 2015
• Start date: November 2012
• Est. completion date: February 2015

Study information

• Verified date: June 2015
• Source: Vejle Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the effect of combined topotecan and veliparib (ABT888) treatment in relapsed ovarian cancer with tumor progression and negative or unknown BRCA mutation status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.

2. Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.

3. 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-twelve months of prior first line/later lines of platinum-based therapy

4. Age = 18 years.

5. Performance status 0-2.

6. Measurable disease by RECIST 1.1 or CA125 GCIG criteria

7. 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 109/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

8. Written informed consent.

9. Tissue available for BRCAness analysis/BRCA mutation analysis.

Exclusion Criteria:

1. Prior treatment with a PARP inhibitor.

2. Patients with BRCA1/2 germline mutation.

3. Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)

4. 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.

5. Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening is mandatory.

6. Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment

7. Other present or previous malignancy except curatively treated cervical cancer stage I, non-melanotic skin cancer or other cancer with minimal risk of relapse. Previous breast cancer is allowed, if disease free follow-up at least five years prior to enrollment.

8. CNS metastasis.

9. History of any chronic medical or psychiatric condition or laboratory abnormality, which 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).

10. Allergy to the ingredients of the study medication.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Drug:
• Veliparib
Veliparib (tablet) twice daily on days 1-3, 7-9, and 14-16 in a 28 days cycle. In phase I the starting dose is 30 mg x 2.
• Topotecan
2 mg/m² iv over 30 minutes on days 2, 8, and 15 in cycles of 28 days. Topotecan is dosed at a maximum body surface area of 2 m².

Locations

Country	Name	City	State
Denmark	Department of Oncology, Vejle Hospital	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Vejle Hospital	Abbott

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib		1 month	Yes
Primary	Phase II: To investigate response rates (based on either CA125 GCIG or RECIST criteria) of combination topotecan and veliparib (ABT888) in relapsed ovarian cancer with negative or unknown BRCA status		Every three months, up to 3 years	No
Secondary	Progression free survival of ovarian cancer patients treated with topotecan and veliparib		Every three months up to three years	No
Secondary	Overall survival of ovarian cancer patients treated with topotecan and veliparib		Every three months, up to three years	No