Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00605618

Purpose

Part A: The purpose of this study is to find the maximum tolerated dose of BMS-777607 in subjects with advanced or metastatic solid tumors

Part B: The purpose of this study is to describe the preliminary activity of BMS-77607 in subjects with advanced or metastatic gastroesophageal cancer, hormone refractory prostate cancer, head and neck squamous cell carcinoma, and type I papillary renal cell carcinoma

Condition	Intervention	Phase
Advanced Solid Tumors	Drug: BMS-777607	Phase I Phase II

MedlinePlus related topics: Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase I/II Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Safety and efficacy assessment including vitals signs, physical assessments, and blood tests [ Time Frame: will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months ] [ Designated as safety issue: Yes ]
Tumor assessments [ Time Frame: will be conducted every 6 weeks. All assessments will continue for at least 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669 [ Time Frame: will be assessed once weekly for the first 3 weeks ] [ Designated as safety issue: No ]
The effects of BMS-777607 on blood pressure (BP), heart rate (HR) [ Time Frame: will be assessed once weekly for the first 3 weeks then every 3 weeks ] [ Designated as safety issue: No ]
Effects on electrocardiogram (ECG), PR interval [ Time Frame: will be assessed at base line, at week 3 and at end of treatment ] [ Designated as safety issue: No ]
Effects on left ventricular function [ Time Frame: will be assessed at baseline and every 3 weeks for 1st 6 weeks then once every 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	March 2008
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: Experimental	Drug: BMS-777607 Suspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 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:

Part A:

Subjects with advanced or metastatic solid tumors who have either progressed on standard therapy or for whom standard therapy is not known

Part B:

Subjects with advanced or metastatic gastroesophageal cancer, HRPrC, HNSCC, or PRCC who have either progressed on standard therapy, or for whom standard therapy is not known. Eighteen (18) subjects each with gastroesophageal cancer, HRPrC, and HNSCC will be treated. Subjects with PRCC (up to 18) will be enrolled as feasible
Tumor paraffin tissue block or 6-10 unstained slides from the tumor tissue block must be provided
Subjects with HRPrC must have either measurable disease or rising PSA levels (≥3 consecutive rising levels with at least 1 week interval and with PSA level ≥5 mg/ml). All other subjects must have measurable disease as assessed by CT or MRI

Exclusion Criteria:

Know brain metastases
Uncontrolled or significant cardiovascular disease
Retinal atrophy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605618

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Locations

United States, New York
Local Institution	Not yet recruiting
New York, New York, United States, 10021
Contact: Site 003
United States, Texas
Local Institution	Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 004
Australia, New South Wales
Local Institution	Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Site 001
Local Institution	Recruiting
Sydney, New South Wales, Australia, 2050
Contact: Site 002
Australia, Western Australia
Local Institution	Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Contact: Site 005

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More 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

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CA192-002
Study First Received:	January 18, 2008
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00605618
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on January 14, 2009