Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers

August 31, 2015 updated by: Bristol-Myers Squibb

A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors

The purpose of this study is to find the maximum tolerated dose of BMS-817378 in subjects with advanced cancers

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Local Institution
  • Singapore
      • Singapore, Singapore, 169610
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of advanced non-hematologic malignancy. Dose expansion cohort restricted to subjects with advanced or metastatic gastroesophageal cancer, squamous cell cancers of the head and neck, and castration resistant prostate cancer
  • ECOG status 0-1

Exclusion Criteria:

  • WOCBP unwilling/unable to use acceptable contraception methods, and women pregnant or breast feeding
  • Symptomatic brain metastasis
  • Uncontrolled or significant cardiovascular disease
  • History of thromboembolic events or bleeding diathesis in past 6 months
  • Conditions requiring prophylactic anticoagulation or chronic anti-platelet therapy
  • Serious non-healing wounds, ulcers or bone fractures in past 3 months
  • Hemorrhage or bleeding event >= CTCAE grade 3 in past 4 weeks
  • Proteinuria >= 2+ on dipstick or >= 1gm/24 hours
  • Concurrent chemotherapy, hormonal therapy, immunotherapy, radiation therapy or therapy with any other investigational product
  • Concurrent herbal, alternative, food supplements, or strong CYP 3A4 inhibitors or inducers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single Arm
Drug: BMS-817378
Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers
Time Frame: Within the first 21 days after first dose of BMS-817378
Within the first 21 days after first dose of BMS-817378

Secondary Outcome Measures

Outcome Measure
Time Frame
Assess safety and tolerability of multiple doses of BMS-817378 administered orally on a once daily schedule in subjects with advanced or metastatic solid tumors
Time Frame: All time points while subject is on study
All time points while subject is on study
Assess the safety and tolerability of co-administration of a CYP substrate cocktail and BMS-817378 given at or below the MTD (dose expansion cohort)
Time Frame: Day 22 +/-2
Day 22 +/-2
Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833
Time Frame: Days 1 and 15
Days 1 and 15
Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction
Time Frame: All time points while subject is on study
All time points while subject is on study
Describe preliminary evidence for anti-tumor activity of BMS-817378
Time Frame: Every 6 weeks
Every 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

November 1, 2010

Study Completion (Anticipated)

November 1, 2010

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (Estimate)

November 18, 2008

Study Record Updates

Last Update Posted (Estimate)

September 1, 2015

Last Update Submitted That Met QC Criteria

August 31, 2015

Last Verified

January 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • CA195-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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