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GW786034 in Treating Patients With Advanced Solid Tumors

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00060151
First Posted: May 7, 2003
Last Update Posted: September 20, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: pazopanib hydrochloride Phase 1

Study Type: Interventional
Study Design: Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I, Open Label, Multiple Dose, Dose Escalation Study OF GW786034 In Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Safety and toxicity assessed weekly during treatment

Secondary Outcome Measures:
  • Disease response every 9 weeks

Study Start Date: December 2002
Study Completion Date: June 2009
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060151


Locations
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00060151     History of Changes
Other Study ID Numbers: CDR0000299531
CASE-CWRU-100231
GSK-VEG10003
GSK-RM2002/00345/02
CWRU-GLAX-1Y02
CWRU-1Y02
CASE-100231
First Submitted: May 6, 2003
First Posted: May 7, 2003
Last Update Posted: September 20, 2013
Last Verified: April 2006

Keywords provided by National Cancer Institute (NCI):
unspecified adult solid tumor, protocol specific