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Ph Ib/BGJ398/Cervix and Other Solid Tumors

NCT02312804 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2015-02-16

No results posted yet for this study

Summary

This study will be conducted using 3+3 design and includes, a dose escalation part to define the MTDfRP2D for the combination of BGJ398 and carboplatin/paclitaxel, and a dose expansion part to treat another 12 patients (only cervix cancer) to further evaluate safety of this combination. Safety, tolerability and MTD will be determined in the dose escalation part of the study. The dose expansion will additionally investigate preliminary anti-tumor efficacy in cervical cancer. The dosing cycle is 21 days.

Conditions

Interventions

DRUG

BGJ398

BGJ398 will be administered orally once daily on each day of the 21 day cycle.

DRUG

Carboplatin

Carboplatin will be administered in combination with paclitaxel intravenously on the first day of each 21-day cycle.

DRUG

Paclitaxel

Paclitaxel will be administered in combination with carboplatin intravenously on the first day of each 21-day cycle.

Sponsors & Collaborators

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Steven Weitman, MD · Clinical Investigator

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-01-31
Completion
2015-01-31

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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 NCT02312804 on ClinicalTrials.gov