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

This study has been withdrawn prior to enrollment.
Information provided by:
Bristol-Myers Squibb Identifier:
First received: November 17, 2008
Last updated: November 12, 2009
Last verified: January 2009

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

Condition Intervention Phase
Advanced Solid Tumors
Drug: BMS-817378
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors

Resource links provided by NLM:

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833 [ Time Frame: Days 1 and 15 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Describe preliminary evidence for anti-tumor activity of BMS-817378 [ Time Frame: Every 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: January 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT00792558

Australia, South Australia
Local Institution
Adelaide, South Australia, Australia, 5000
Australia, Western Australia
Local Institution
Nedlands, Western Australia, Australia, 6009
Local Institution
Singapore, Singapore, 169610
Sponsors and Collaborators
Bristol-Myers Squibb
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00792558     History of Changes
Other Study ID Numbers: CA195-001
Study First Received: November 17, 2008
Last Updated: November 12, 2009
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Singapore: Ministry of Health processed this record on April 16, 2014