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

NCT00605618 | Completed Phase 1

• 1 other identifier: CA192-002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (2)

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

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

• Tumor assessments

  will be conducted every 6 weeks. All assessments will continue for at least 24 months

Secondary Outcomes (4)

• Pharmacokinetics (PK) of BMS-777607 and its N-oxide metabolite, BMS-797669

  will be assessed once weekly for the first 3 weeks

• The effects of BMS-777607 on blood pressure (BP), heart rate (HR)

  will be assessed once weekly for the first 3 weeks then every 3 weeks

• Effects on electrocardiogram (ECG), PR interval

  will be assessed at base line, at week 3 and at end of treatment

• Effects on left ventricular function

  will be assessed at baseline and every 3 weeks for 1st 6 weeks then once every 6 months

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: BMS-777607

Interventions

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

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Know brain metastases
• Uncontrolled or significant cardiovascular disease
• Retinal atrophy

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (2)

Local Institution

Camperdown, New South Wales, 2050, Australia

Location

Local Institution

Kogarah, New South Wales, 2217, Australia

Location

Related Links

• Investigator Inquiry form

MeSH Terms

Interventions

N-(4-(2-amino-3-chloropyridin-4-yloxy)-3-fluorophenyl)-4-ethoxy-1-(4-fluorophenyl)-2-oxo-1,2-dihydropyridine-3-carboxamide

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 18, 2008
• First Posted: January 31, 2008
• Study Start: March 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: January 25, 2011

Record last verified: 2009-08

Locations

AU (2)