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A Phase I/II Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Advanced Solid Tumors

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Trial Information

A Phase I/II Multiple Ascending Dose Study of BMS-777607 in Subjects With Advanced or Metastatic Solid Tumors


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and efficacy assessment including vitals signs, physical assessments, and blood tests

Outcome Time Frame:

will be conducted weekly for the first 3 weeks then every 3 weeks. All assessments will continue for at least 24 months

Safety Issue:

Yes

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CA192-002

NCT ID:

NCT00605618

Start Date:

March 2008

Completion Date:

March 2009

Related Keywords:

  • Advanced Solid Tumors
  • Neoplasms

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