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Recruitment Status : Withdrawn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

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

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: BMS-817378 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : January 2009
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : November 2010

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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833 [ Time Frame: Days 1 and 15 ]
  4. 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 ]
  5. Describe preliminary evidence for anti-tumor activity of BMS-817378 [ Time Frame: Every 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb Identifier: NCT00792558     History of Changes
Other Study ID Numbers: CA195-001
First Posted: November 18, 2008    Key Record Dates
Last Update Posted: September 1, 2015
Last Verified: January 2009