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BNC105P Combination Study in Partially Platinum Sensitive Ovarian Cancer Patients

NCT01624493 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2015-12-23

No results posted yet for this study

Summary

This phase I/II trial will determine the recommended dose and activity of BNC105P for patients with partially platinum sensitive ovarian cancer in first or second relapse.

Conditions

Interventions

DRUG

Carboplatin

Carboplatin AUC4 on day 1 of 21-day cycle, for a maximum of 6 cycles.

DRUG

Gemcitabine

Gemcitabine escalations 800 and 1000 mg/m2 (as determined in phase I) on days 1 and 8 of a 21 day cycle, for a maximum of 6 cycles.

DRUG

Carboplatin

Carboplatin AUC 4 on day 1 of a 21 day cycle, for a maximum of 6 cycles.

DRUG

Gemcitabine

Gemcitabine 800 or 1000 mg/m2 (as determined in phase I) on days 1 and day 8 of 21-day cycle, for a maximum of 6 cycles.

DRUG

BNC105P

BNC105P as determined in phase I, on days 2 and 9 of a 21 day cycle for a maximum of 6 cycles, followed by single agent maintenance BNC105P 16 mg/m2 for a maximum of 6 additional cycles.

Sponsors & Collaborators

  • University of Sydney

    collaborator OTHER

  • Australia New Zealand Gynaecological Oncology Group

    collaborator OTHER

  • Bionomics Limited

    collaborator INDUSTRY

  • Hoosier Cancer Research Network

    lead OTHER

Principal Investigators

  • Danny Rischin, Professor · University of Sydney

  • Daniela Matei, M.D. · Hoosier Cancer Research Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-07-31
Completion
2014-10-31

Countries

  • United States
  • Australia
  • New Zealand

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01624493 on ClinicalTrials.gov