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.
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
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- 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
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.
Safety and toxicity assessed weekly during treatment
Secondary outcomes (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.
- First posted7 May 2003 (estimated)
- Study startDec 2002
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Afshin Dowlati, MD, Study chair, Case Comprehensive Cancer Center
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label, Multiple Dose, Dose Escalation Study OF GW786034 In Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT00060151
- Acronym / sponsor ID
- CDR0000299531
- Keywords
- unspecified adult solid tumor, protocol specific
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2002
- Study completion
- Jun 2009 (actual)
- First posted
- 7 May 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pazopanib hydrochloride | Drug | – |
Primary outcome
Safety and toxicity assessed weekly during treatment
1 secondary outcome
Disease response every 9 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2013.
- Results publication: PubMed 19509175Hurwitz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Afshin Dowlati, MD study chair
Case Comprehensive Cancer Center
2 sites in 1 country: see every site and its status.
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.