NCT01472783

Brief Summary

The main purpose of this study is to investigate the effect of veliparib in ovarian cancer patients with known BRCA 1/2 mutations who do no longer respond to conventional chemotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2011

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 16, 2011

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

4.2 years

First QC Date

November 2, 2011

Last Update Submit

November 15, 2016

Conditions

Recurrent, Epithelial Ovarian Cancer

Keywords

BRCA1 mutationBRCA2 mutationOvarian cancerPARP inhibitor

Outcome Measures

Primary Outcomes (2)

  • Phase I: Maximum tolerated dose, dose limiting toxicity, recommended phase II dose.

    6 months

  • Phase II: Response rate

    Every 3 months

Secondary Outcomes (2)

  • Progression free survival

    Every 3 months

  • Overall survival

    Every 3 months

Study Arms (1)

Veliparib

EXPERIMENTAL
Drug: Veliparib

Interventions

VeliparibDRUG

Veliparib (tablet) 300 mg twice daily on days 1-28 of 28 days cycles until progression, unacceptable toxicity or patient refusal.

Veliparib

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed epithelial, primary fallopian or primary peritoneal cancer. Stages I-IV.
  • Patients with known germline BRCA1/2 mutations
  • 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 to 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 evaluable by CA125 GCIG criteria
  • Adequate bone marrow function, liver function, renal function and coagulation parameters (within 7 days prior to randomization):
  • 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
  • Written informed consent.
  • Tissue available for BRCAness analysis.

You may not qualify if:

  • Previous treatment with a PARP inhibitor.
  • 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 regimen, or who have participated in another clinical trial within 28 days prior to entering this trial.
  • Pregnant or breast-feeding patients. 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.
  • CNS metastasis.
  • 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).
  • Allergy to the ingredients of the study medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Oncology, Vejle Hospital

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

RecurrenceCarcinoma, Ovarian EpithelialOvarian Neoplasms

Interventions

veliparib

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Anders Jakobsen, DMSc

    Vejle Hospital, Vejle, Denmark

    STUDY CHAIR

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

November 2, 2011

First Posted

November 16, 2011

Study Start

November 1, 2011

Primary Completion

January 1, 2016

Study Completion

August 1, 2016

Last Updated

November 16, 2016

Record last verified: 2016-11

Locations

DK(1)