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

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ClinicalTrials.gov Identifier: NCT00605618
Recruitment Status : Completed
First Posted : January 31, 2008
Last Update Posted : January 25, 2011
Sponsor:
Information provided by:
Bristol-Myers Squibb

Brief Summary:

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 or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: BMS-777607 Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors
Study Start Date : March 2008
Primary Completion Date : March 2009
Study Completion Date : March 2009

Arm Intervention/treatment
Experimental: Single Arm 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



Primary Outcome Measures :
  1. 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 ]
  2. Tumor assessments [ Time Frame: will be conducted every 6 weeks. All assessments will continue for at least 24 months ]

Secondary Outcome Measures :
  1. Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669 [ Time Frame: will be assessed once weekly for the first 3 weeks ]
  2. 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 ]
  3. Effects on electrocardiogram (ECG), PR interval [ Time Frame: will be assessed at base line, at week 3 and at end of treatment ]
  4. 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 ]


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
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

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 ClinicalTrials.gov identifier (NCT number): NCT00605618


Locations
Australia, New South Wales
Local Institution
Camperdown, New South Wales, Australia, 2050
Local Institution
Kogarah, New South Wales, Australia, 2217
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00605618     History of Changes
Other Study ID Numbers: CA192-002
First Posted: January 31, 2008    Key Record Dates
Last Update Posted: January 25, 2011
Last Verified: August 2009