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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00792558
Recruitment Status : Withdrawn
First Posted : November 18, 2008
Last Update Posted : September 1, 2015
Information provided by:
Bristol-Myers Squibb

November 17, 2008
November 18, 2008
September 1, 2015
January 2009
November 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00792558 on Archive Site
  • 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 ]
  • 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 ]
  • Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833 [ Time Frame: 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 ]
  • Describe preliminary evidence for anti-tumor activity of BMS-817378 [ Time Frame: Every 6 weeks ]
Same as current
Not Provided
Not Provided
Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers
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
Not Provided
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Advanced Solid Tumors
Drug: BMS-817378
Capsule, Oral, Dose escalation to a MTD from a starting dose of 25 mg, once daily, until disease progression/subject discontinuation
Experimental: Single Arm
Intervention: Drug: BMS-817378
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2010
November 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Australia,   Singapore
Not Provided
Not Provided
Not Provided
Study Director, Bristol-Myers Squibb
Bristol-Myers Squibb
Not Provided
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Bristol-Myers Squibb
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP