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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Vejle Hospital
Sponsor:
Collaborator:
Abbott
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01690598
First received: September 17, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Ovarian Cancer
Drug: Veliparib
Drug: Topotecan
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Phase I: Maximum tolerated dose, dose limiting toxicity and thus recommend phase II dose of veliparib [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Every three months, up to 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free survival of ovarian cancer patients treated with topotecan and veliparib [ Time Frame: Every three months up to three years ] [ Designated as safety issue: No ]
  • Overall survival of ovarian cancer patients treated with topotecan and veliparib [ Time Frame: Every three months, up to three years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: November 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Veliparib and Topotecan 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.
Drug: 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690598

Contacts
Contact: Anders Jakobsen, MD, DMSc anders.jakobsen@rsyd.dk
Contact: Hanne Kanstrup, MD hanne.kanstrup@rsyd.dk

Locations
Denmark
Department of Oncology, Vejle Hospital Recruiting
Vejle, Denmark, DK-7100
Contact: Anders Jakobsen, DMSc         
Principal Investigator: Hanne Kanstrup, MD         
Sub-Investigator: Karina D Steffensen, MD, PhD         
Sub-Investigator: Parvin Adimi, MD         
Sponsors and Collaborators
Vejle Hospital
Abbott
Investigators
Study Chair: Anders Jakobsen, MD, DMSc Vejle Hospital
Principal Investigator: Hanne Kanstrup, MD Vejle Hospital
  More Information

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01690598     History of Changes
Other Study ID Numbers: VeTo
Study First Received: September 17, 2012
Last Updated: December 6, 2013
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by Vejle Hospital:
Epithelial ovarian cancer
BRCA mutation
Platinum resistant
Platinum sensitive
Relapsed ovarian cancer

Additional relevant MeSH terms:
Ovarian Neoplasms
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Histologic Type
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 18, 2014