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

Advanced Solid Tumors Clinical Trial

Official title:

A Phase I Ascending Multiple-Dose Study of BMS-817378 in Subjects With Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00792558
• Other study ID #: CA195-001
• Status: Withdrawn
• Phase: Phase 1
• First received: November 17, 2008
• Last updated: August 31, 2015
• Start date: January 2009
• Est. completion date: November 2010

Study information

• Verified date: January 2009
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Department of Health and Ageing Therapeutic Goods AdministrationSingapore: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

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

Locations

Country	Name	City	State
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Nedlands	Western Australia
Singapore	Local Institution	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Australia,  Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To establish the MTD of BMS-817378 when administered orally on a daily schedule in subjects with advanced cancers		Within the first 21 days after first dose of BMS-817378	Yes
Secondary	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		All time points while subject is on study	Yes
Secondary	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)		Day 22 +/-2	Yes
Secondary	Characterize the pharmacokinetics of BMS-817378 and its active moiety, BMS-794833		Days 1 and 15	No
Secondary	Assess the effects of BMS-817378 and BMS-794833 on blood pressure, heart rate, ECG intervals, and left ventricular ejection fraction		All time points while subject is on study	Yes
Secondary	Describe preliminary evidence for anti-tumor activity of BMS-817378		Every 6 weeks	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm