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Completed

NCT Number: NCT00605618

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

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

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BMS-777607

Drug

Suspension/Tablet, Oral, Dose escalation to an MTD from a starting dose of 10 mg, once daily, until disease progression/subject discontinuation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 31, 2008
Registry last updated
Jan 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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