BMS-599626 in Patients With Advanced Solid Malignancies

February 27, 2010 updated by: Bristol-Myers Squibb

Phase I Study of BMS-599626 in Patients With Advanced Solid Malignancies, Including Malignancies That Express HER2 at the Maximum Tolerated Dose and/or Recommended Phase II Dose

The purpose of this trial is to identify the highest oral dose of BMS-599626, a drug that is directed against EGFR and HER2 proteins, that can be given safely on a daily schedule of 21 days with a 7 day rest period in patients with cancer who no longer benefit from other commonly used treatments. The study will also test for other proteins that may be affected by BMS-599626; and the level of study drug in the blood will be studied.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States
        • Local Institution
      • Tucson, Arizona, United States
        • Local Institution
    • California
      • Los Angeles, California, United States
        • Local Institution

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of metastatic cancer that has progressed on currently available therapies;
  • At least 3 month life expectancy;
  • Primary cancer must be solid (non-hematologic);
  • Adequate bone marrow, liver & kidney function;
  • Negative pregnancy test.

Exclusion Criteria:

  • Serious, uncontrolled medical disorder;
  • Individuals not willing or able to use an acceptable method to avoid pregnancy for the entire study period and for at least 3 months after the study;
  • Pregnant or breastfeeding women;
  • Patients with known brain metastasis;
  • Uncontrolled or significant cardiovascular disease;
  • Anticancer therapy within 2-6 weeks prior to study drug (depending on the therapy)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Phase 1 MTD Study
Drug: panHer
Tablets, Oral, A modified Fibonocci dose escalation system initiated at 100mg and escalating up to 880mg maximum dose (rounded down to 20mg increments based on smallest tablet size); -2 40mg -33%; -1 60mg -40%; 1 100mg --; 2 200mg 100%; 3 320mg 67%; 4 480mg 50%; 5 660mg 40%; 6 880mg 33.3%, Daily, Until DLT or study MTD is reached.
Other Names:
  • BMS-599626

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Det. the max tolerated dose,biologically active doses & recommended phase 2 dose of BMS-599626 when adm. as a daily oral dose to pts with HER2 expressing-metastatic solid tumors who have progressed on or following standard therapy

Secondary Outcome Measures

Outcome Measure
Evaluate the effect of BMS-599626 on biomarkers & predictive markers of HER1/2 in skin metabolic act. through PET imaging & preliminary evidence of anti-tumor act.,determine the effect of gastric acid modifying agents on systemic exposure of BMS-599626

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

November 5, 2004

First Submitted That Met QC Criteria

November 5, 2004

First Posted (Estimate)

November 8, 2004

Study Record Updates

Last Update Posted (Estimate)

March 2, 2010

Last Update Submitted That Met QC Criteria

February 27, 2010

Last Verified

October 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA181-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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