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

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

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:

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 ]

Enrollment:	8
Study Start Date:	March 2008
Study Completion Date:	March 2009
Primary Completion Date:	March 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

Locations

Australia, New South Wales
Local Institution
Kogarah, New South Wales, Australia, 2217
Local Institution
Sydney, New South Wales, Australia, 2050

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

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:	CA192-002
Study First Received:	January 18, 2008
Last Updated:	September 2, 2009
ClinicalTrials.gov Identifier:	NCT00605618 History of Changes
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

ClinicalTrials.gov processed this record on September 10, 2009