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Carboplatin/Taxol/Ridaforolimus in Endometrial, Ovarian and Solids

NCT01256268 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2017-08-30

No results posted yet for this study

Summary

The purpose of this study is to:

* Test the safety of a new investigational drug called MK-8669 (ridaforolimus)
* Determine the maximum tolerated dose of MK-8669
* Determine the effectiveness of the maximum tolerated dose of MK-8669

Conditions

Interventions

DRUG

Ridaforolimus

Phase 1A: Ridaforolimus 20-40 mg will be administered daily for 5 days per week (days 2-5, days 8-12, days 15-19) in the first cycle of therapy and for further cycles on days 1-5, days 8-12, days 15-19 throughout the remainder of therapy. On the day of coadministration of ridaforolimus with paclitaxel 175mg/m\^2 IV and carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle, ridaforolimus will be dosed at the time of initiation of paclitaxel infusion. Phase 1B: as outlined in Treatment Arms.

DRUG

Paclitaxel

Phase 1A: Paclitaxel 175mg/m2 IV. Phase 1B: As outlined in Treatment Arms.

DRUG

carboplatin

Phase 1A: Carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle. Phase 1B: As outlined in Treatment Arms.

Sponsors & Collaborators

Principal Investigators

  • Robert Wenham, M.D. · H. Lee Moffitt Cancer Center and Research Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-13
Primary Completion
2016-02-03
Completion
2017-08-03

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT01256268 on ClinicalTrials.gov