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

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00792558
First received: November 17, 2008
Last updated: August 31, 2015
Last verified: January 2009

November 17, 2008
August 31, 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 ClinicalTrials.gov 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
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Singapore
 
 
NCT00792558
CA195-001
Not Provided
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