GW786034 in Treating Patients With Advanced Solid Tumors

September 19, 2013 updated by: Case Comprehensive Cancer Center

A Phase I, Open Label, Multiple Dose, Dose Escalation Study OF GW786034 In Patients With Solid Tumors

RATIONALE: GW786034 may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth and by stopping blood flow to the tumor.

PURPOSE: This phase I trial is studying the side effects and best dose of GW786034 in treating patients with advanced solid tumors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the safety and tolerability of GW786034 in patients with advanced solid tumors.
  • Determine the maximum tolerated dose of this drug in these patients.
  • Determine the pharmacokinetics of this drug in these patients.
  • Determine the clinical response in patients treated with this drug.
  • Evaluate the effect of this drug on biomarkers of angiogenesis activity in order to estimate activity and to determine the minimum biologically active dose in these patients.

OUTLINE: This is an open-label, nonrandomized, dose-escalation, multicenter study.

Patients receive oral GW786034 twice daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 2-6 patients receive escalating doses of GW786034 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 21 days.

PROJECTED ACCRUAL: Approximately 30-50 patients will be accrued for this study.

Study Type

Interventional

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
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke Comprehensive Cancer Center
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • Case Comprehensive Cancer Center

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Histologically confirmed advanced solid tumor
  • Refractory to standard therapy or for which no standard therapy exists

  • No untreated leptomeningeal or brain metastases

    • Previously treated brain metastases are allowed if currently asymptomatic and patient is off steroids and antiseizure medications for more than 3 months before study entry

PATIENT CHARACTERISTICS:

Age

  • 21 and over

Performance status

  • Karnofsky 70-100%

Life expectancy

  • At least 12 weeks

Hematopoietic

  • Absolute granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL

Hepatic

  • Bilirubin no greater than 1.5 mg/dL
  • AST and ALT no greater than 2 times upper limit of normal (ULN) (5 times ULN if tumor involvement)

Renal

  • Creatinine clearance at least 60 mL/min

Cardiovascular

  • No uncontrolled hypertension (systolic blood pressure greater than 160 mm Hg or diastolic blood pressure greater than 100 mm Hg on 2 consecutive measurements separated by 1 week)
  • No arterial or venous thrombosis (including cerebrovascular accident) within the past 3 months
  • No myocardial infarction within the past 3 months
  • No unstable angina within the past 3 months
  • No cardiac angiopathy or stenting within the past 3 months
  • No cardiac pacemaker

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 21 days after study treatment
  • Able to swallow and retain oral medication
  • Good venous access
  • No prior or concurrent gastrointestinal disease
  • No prior or concurrent condition known to interfere with the absorption, distribution, metabolism, or excretion of drugs
  • No known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to study drug
  • No other unstable, pre-existing major medical condition
  • No orthopedic pins or rods or other embedded metal that would preclude undergoing an MRI
  • No psychological, familial, sociological, or geographical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • More than 4 weeks since prior immunotherapy
  • Concurrent epoetin alfa allowed
  • No concurrent anticancer biologic therapy

Chemotherapy

  • More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
  • No concurrent anticancer cytotoxic chemotherapy

Endocrine therapy

  • See Disease Characteristics
  • More than 4 weeks since prior hormonal or steroid therapy (other than replacement)
  • No concurrent anticancer hormonal therapy (except for replacement)
  • No concurrent dexamethasone or prednisone

Radiotherapy

  • More than 4 weeks since prior radiotherapy
  • No concurrent anticancer radiotherapy

Surgery

  • More than 4 weeks since prior major surgery
  • No concurrent surgery for cancer

Other

  • Recovered from prior therapy
  • More than 4 weeks since prior investigational agents
  • More then 28 days since prior alteration of antihypertensive medications
  • Concurrent bisphosphonates allowed
  • No other concurrent anticancer therapy
  • No concurrent antidepressants (e.g., amitriptyline, fluoxetine, or fluvoxamine)
  • No concurrent oral hypoglycemics (e.g., glipizide, glyburide, rosiglitazone, or tolbutamide)

  • No concurrent therapeutic anticoagulation (e.g., warfarin at therapeutic doses)

    • Low-dose anticoagulation for prophylaxis allowed
  • No concurrent cyclosporine
  • No concurrent grapefruit juice
  • No concurrent amiodarone, mibefradil, phenobarbital, or pioglitazone
  • No concurrent Hypericum perforatum (St. John's Wort)
  • No concurrent rifabutin or diethyldithiocarbamate
  • No concurrent gestodene, mifepristone, or modafinil
  • No concurrent herbal supplements, vitamins, or non-traditional compounds

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
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and toxicity assessed weekly during treatment

Secondary Outcome Measures

Outcome Measure
Disease response every 9 weeks

Collaborators and Investigators

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

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2002

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

May 6, 2003

First Submitted That Met QC Criteria

May 6, 2003

First Posted (Estimate)

May 7, 2003

Study Record Updates

Last Update Posted (Estimate)

September 20, 2013

Last Update Submitted That Met QC Criteria

September 19, 2013

Last Verified

April 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000299531
  • CASE-CWRU-100231
  • GSK-VEG10003
  • GSK-RM2002/00345/02
  • CWRU-GLAX-1Y02
  • CWRU-1Y02
  • CASE-100231

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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