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

NCT01690598 | Completed Phase 1 DMC

• 1 other identifier: VeTo
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ovarian Cancer

Keywords

Epithelial ovarian cancer; BRCA mutation; Platinum resistant; Platinum sensitive; Relapsed ovarian cancer

Outcome Measures

Primary Outcomes (2)

• Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib

  1 month

• 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

Secondary Outcomes (2)

• Progression free survival of ovarian cancer patients treated with topotecan and veliparib

  Every three months up to three years

• Overall survival of ovarian cancer patients treated with topotecan and veliparib

  Every three months, up to three years

Study Arms (1)

Veliparib and Topotecan

EXPERIMENTAL

Drug: Veliparib; Drug: Topotecan

Interventions

Veliparib DRUG

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.

Veliparib and Topotecan

Topotecan DRUG

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.

Veliparib and Topotecan

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer.
• Verified progression by either RECIST criteria and/or GCIG CA125 criteria after previous first line chemotherapy or progression after later lines of cytotoxic treatment.
• 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
• Age ≥ 18 years.
• Performance status 0-2.
• Measurable disease by RECIST 1.1 or CA125 GCIG criteria
• 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

You may not qualify if:

• Prior treatment with a PARP inhibitor.
• Patients with BRCA1/2 germline mutation.
• Platinum-refractory disease (disease that progressed or was stable during prior platinum therapy)
• 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.
• Pregnant or breast-feeding. For fertile women a negative pregnancy test at screening is mandatory.
• Fertile patients not willing to use acceptable and safe methods of contraception during and for 6 months after treatment
• 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.
• CNS metastasis.
• 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).
• Allergy to the ingredients of the study medication.

Sponsors & Collaborators

• Vejle Hospital: lead
• Abbott: collaborator

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, DK-7100, Denmark

Location

Related Publications (1)

• Hjortkjaer M, Kanstrup H, Jakobsen A, Steffensen KD. Veliparib and topotecan for patients with platinum-resistant or partially platinum-sensitive relapse of epithelial ovarian cancer with BRCA negative or unknown BRCA status. Cancer Treat Res Commun. 2018;14:7-12. doi: 10.1016/j.ctarc.2017.09.001. Epub 2017 Sep 27. No abstract available.

  PMID: 30104007 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

veliparib; Topotecan

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Anders Jakobsen, MD, DMSc

  Vejle Hospital

  STUDY CHAIR

• Hanne Kanstrup, MD

  Vejle Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2012
• First Posted: September 24, 2012
• Study Start: November 1, 2012
• Primary Completion: January 1, 2015
• Study Completion: February 1, 2015
• Last Updated: June 10, 2015

Record last verified: 2015-06

Locations

DK (1)