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Unspecified Adult Solid Tumor, Protocol SpecificPhase 1NCT00060151

GW786034 in Treating Patients With Advanced Solid Tumors

A Phase 1 study testing pazopanib hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 21 years and older
What is being tested?
pazopanib hydrochloride
How many people
Not given
Where
2 sitesUnited States
Study dates
Dec 2002to Jun 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Case Comprehensive Cancer Center

    Cleveland, Ohio, 44106-5065

  • Duke Comprehensive Cancer Center

    Durham, North Carolina, 27710

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
pazopanib hydrochloride
Keywords
unspecified adult solid tumor, protocol specific

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • pazopanib hydrochlorideDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and toxicity assessed weekly during treatment

Secondary outcomes (1)
  1. Disease response every 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2003 (estimated)
  2. Study startDec 2002
  3. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Masking
None (open label)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00060151
Sponsor's protocol ID
CDR0000299531
Other IDs
CASE-CWRU-100231, GSK-VEG10003, GSK-RM2002/00345/02, CWRU-GLAX-1Y02, CWRU-1Y02, CASE-100231
Status last verified
Apr 2006
First submitted
6 May 2003
Last updated
20 Sep 2013
Results posted
No

Publications

  • Hurwitz HI, Dowlati A, Saini S, Savage S, Suttle AB, Gibson DM, Hodge JP, Merkle EM, Pandite L. Phase I trial of pazopanib in patients with advanced cancer. Clin Cancer Res. 2009 Jun 15;15(12):4220-7. doi: 10.1158/1078-0432.CCR-08-2740. Epub 2009 Jun 9.

    PubMed 19509175

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pazopanib hydrochloride in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Case Comprehensive Cancer Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and toxicity assessed weekly during treatment. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00060151, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2013.

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