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Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced Cancers
This study has been withdrawn prior to recruitment.
First Received: November 17, 2008   Last Updated: November 12, 2009   History of Changes
Sponsor: Bristol-Myers Squibb
Information provided by: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00792558
  Purpose

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 I

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety Study
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:

MedlinePlus related topics: Cancer
U.S. FDA Resources

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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT00792558

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

Additional Information:
BMS Clinical Trials Disclosure  This link exits the ClinicalTrials.gov site
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bristol-Myers Squibb ( Study Director )
Study ID Numbers: CA195-001
Study First Received: November 17, 2008
Last Updated: November 12, 2009
ClinicalTrials.gov Identifier: NCT00792558     History of Changes
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration;   Singapore: Ministry of Health

ClinicalTrials.gov processed this record on February 08, 2010



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