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Dose-finding Study in Platinum-Resistant Ovarian Cancer

NCT01653912 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-04-02

Study results available
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Summary

* Dose-finding study of GSK2110183 administered in combination with carboplatin and paclitaxel to any subject with recurrent ovarian cancer.
* Safety and efficacy study of GSK2110183 administered in combination with carboplatin and paclitaxel to subjects with platinum-resistant ovarian cancer.

Conditions

  • Recurrent Platinum-resistant Ovarian Cancer

Interventions

DRUG

GSK2110183 in combination with carboplatin and paclitaxel

Phase I is a dose escalation evaluation of increasing doses of GSK2110183 administered on a continuous daily schedule in combination with carboplatin AUC 5 and paclitaxel 175mg/m2 given every three weeks for a maximum 6 cycles. The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. Treatment with the three drug regimen will continue for a maximum of 6 x 21 day cycles followed by continuous GSK2110183 at the single agent MTD. Subjects may continue on study drug until progression, death or unacceptable toxicity.

Sponsors & Collaborators

  • Accenture

    lead INDUSTRY

Principal Investigators

  • Richard A Brigandi, MD, PhD, FAAP · GlaxoSmithKline

  • Anne L Hamilton · Royal Women's Hospital

  • Sarah P Blagden · Imperial College Healthcare NHS Trust

  • Linda Mileshkin · Peter MacCallum Cancer Centre, Australia

  • Shirley S Wong · Western Hospital

  • Andrew Dean · Sir Charles Gairdner Hospital

  • Marcia Hall · Mount Vernon Cancer Center

  • Bhawana Awasthy, MD · Syneos Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-11-30
Primary Completion
2015-07-31
Completion
2015-11-30

Countries

  • Australia
  • Russia
  • United Kingdom

Study Locations

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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 NCT01653912 on ClinicalTrials.gov