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Veliparib and Topotecan for Relapsed Ovarian Cancer With Negative or Unknown BRCA Status | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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

NCT01690598•Vejle Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

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
+7 more criteria

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.

Locations (1)

Department of Oncology, Vejle Hospital

Vejle, Denmark

Key Dates

Start Date

November 1, 2012

Primary Completion Date

January 1, 2015

Completion Date

February 1, 2015

Last Updated

June 10, 2015

Enrollment

ACTUAL participants

Conditions

Ovarian Cancer

Interventions

Veliparib

DRUG

Topotecan

DRUG

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RECRUITINGPHASE2

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Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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