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Recurrent MelanomaPhase 2NCT00861913

Pazopanib Hydrochloride in Treating Patients With Metastatic Melanoma That Cannot be Removed by Surgery

A Phase 2 study testing Laboratory Biomarker Analysis, Pazopanib Hydrochloride and Pharmacological Study in people with Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, run by National Cancer Institute (NCI) at 4 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

This phase II trial is studying the side effects of pazopanib hydrochloride and to see how well it works in treating patients with metastatic melanoma that cannot be removed by surgery. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Laboratory Biomarker Analysis, Pazopanib Hydrochloride and Pharmacological Study
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
4 sitesUnited States
Study dates
3 Apr 2009to 16 Jan 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Histologically confirmed unresectable malignant melanoma
  • Radiographic or clinical evidence of metastatic disease
  • Measurable disease with ≥ 1 lesion whose longest diameter can be measured as ≥ 2.0 cm by CT or MRI scans or ≥ 1.0 cm by spiral CT scan
  • Disease that is measurable by physical examination only is not allowed
  • No known intraluminal metastatic lesion(s) with suspected bleeding
  • No brain metastases by MRI or CT scan
Show all 54Show fewer
  • ECOG performance status 0-2
  • Life expectancy > 12 weeks
  • WBC ≥ 3,000/μL
  • Hemoglobin ≥ 9 g/dL
  • Absolute neutrophil count ≥ 1,500/μL
  • Platelets ≥ 100,000/μL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • AST and ALT ≤ 2.5 times ULN
  • Creatinine ≤ 1.5 times ULN
  • Serum troponin normal
  • Urine protein ≤ 1+ (≤ 30 mg/dL) on 2 consecutive dipstick or other urine assessments taken ≥ 1 week apart
  • QTc interval < 480 msec
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant ECG abnormalities (e.g., frequent ventricular ectopy, evidence of ongoing myocardial ischemia)
  • No serious nonhealing wound, ulcer, or bone fracture
  • No history of abdominal fistula, gastrointestinal perforation, active diverticulitis, intra-abdominal abscess, or gastrointestinal tract bleeding within the past 28 days
  • No history of myocardial infarction, cardiac arrhythmia within the past 6 months
  • No NYHA class III-IV heart failure
  • Patients with a history of class II heart failure and who are asymptomatic on treatment may be eligible
  • No history of bleeding disorder, including hemophilia, disseminated intravascular coagulation, or any other abnormality of coagulation potentially predisposing patients to bleeding
  • No uncontrolled infection
  • No evidence of active bleeding or bleeding diathesis
  • No hemoptysis within 6 weeks of first dose of study drug
  • No active peptic ulcer disease
  • No inflammatory bowel disease
  • No ulcerative colitis or other gastrointestinal conditions with increased risk of perforation
  • No history of cerebrovascular accident, including transient ischemic attack, pulmonary embolism, or untreated deep venous thrombosis within the past 6 months
  • Patients with recent deep vein thrombosis who have been treated with therapeutic anticoagulating agents within the past 6 weeks are eligible
  • No known endobronchial lesions or involvement of large pulmonary vessels by tumor
  • No current active hepatic or biliary disease, except Gilbert syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease
  • No uncontrolled hypertension (i.e., systolic blood pressure [BP] > 140 mm Hg and diastolic BP > 90 mm Hg)
  • No condition that impairs ability to swallow and retain pazopanib hydrochloride (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for IV alimentation, prior surgical procedures affecting absorption, or active peptic ulcer disease)
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to pazopanib hydrochloride or other agents used in the study
  • No uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would or might reasonably be expected to limit compliance with study requirements
  • No admission for unstable angina, cardiac angioplasty, or stenting within the past 6 months
  • More than 6 weeks since prior major surgery
  • More than 4 weeks since prior and no concurrent radiotherapy
  • At least 14 days or 5 half-lives and no concurrent CYP interactive medications
  • No prior radiotherapy to ≥ 25% of bone marrow
  • No prior therapy with a VEGFR tyrosine-kinase inhibitor
  • No concurrent antiretroviral therapy for HIV-positive patients
  • No concurrent medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of pazopanib hydrochloride
  • No concurrent chemotherapy
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
  • No concurrent medications that are associated with a risk of QTc prolongation and/or Torsades de Pointes

Who cannot join

None listed.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Mayo Clinic

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: Phase II Trial of Pazopanib (GW786034) in Pre-Treated and Untreated Metastatic Melanoma Patients

This phase II trial is studying the side effects of pazopanib hydrochloride and to see how well it works in treating patients with metastatic melanoma that cannot be removed by surgery. Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To assess the anti-tumor activity and safety profile of single agent Pazopanib (pazopanib hydrochloride).

SECONDARY OBJECTIVES:

  1. To assess the impact of Pazopanib on circulating levels of vascular endothelial growth factor (VEGF).

II. To examine the association between tumor response and B-Raf and N-Ras mutations.

III. To examine pre/post-treatment expression levels of VEGF, vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, and Ki67.

IV. To correlate baseline and changes in p-ERK levels in the tumor with response.

  1. To determine pazopanib steady-state trough plasma concentrations (Css,min) and the relationships between Css,min and the PD effects and toxicities of pazopanib.

VI. To examine the associations of common polymorphisms in CYP1A2, CYP2C8, UGT1A1, ABCB1, and ABCG2 with the PK and PD of pazopanib.

VII. To Assess Progression Free Survival. VIII. To Assess Overall Survival.

OUTLINE: This is a multicenter study.

Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo tumor tissue biopsy at baseline and blood sample collection at baseline and on days 14, 28, and 42 for research studies. Tumor tissue samples are analyzed by DNA sequencing, ELISA, western blotting, and immunoperoxidase staining. Blood samples are analyzed for pharmacodynamics, pharmacokinetics, and pharmacogenetics by high-performance liquid chromatography with tandem mass spectrometry.

After completion of study treatment, patients are followed periodically for up to 5 years.

Being tested
Laboratory Biomarker Analysis, Pazopanib Hydrochloride, Pharmacological Study
Medical subject headings
Melanoma

What participants receive

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

  • Laboratory Biomarker AnalysisOther

    Correlative studies

  • Pazopanib HydrochlorideDrug

    Also called GW786034B, Votrient

    Given orally

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT00861913
Study groupRoleWhat they receive
Treatment (pazopanib hydrochloride)ExperimentalPatients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Receives: Other: Laboratory Biomarker Analysis; Drug: Pazopanib Hydrochloride; Other: Pharmacological Study

What is being measured

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

  1. Tumor Response Rate

    Tumor response rate is defined as the number of eligible patients whose disease status meets the Response Evaluation Criteria In Solid Tumors (RECIST) criteria for compete response (CR) or partial response (PR) divided by the number of evaluable patients. A ninety percent confidence interval for the true response proportion will be calculated assuming that the number of confirmed tumor responses follows a binomial distribution and using the Duffy-Santner approach.

    Complete Response (CR): Disappearance of all target lesions.

    Partial Response (PR): At least a 30% decrease in the sum of the largest dimension (LD) of target lesions taking as reference the baseline sum LD.

    Measured: Up to 5 years

  2. Toxicity

    Toxicity is defined as any grade 3 or higher adverse event as assessed using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0 and at least possibly related to treatment. The maximum grade for each type of toxicity will be recorded for each patient. We report the number of patients experiencing a grade 3 or higher adverse event at least possibly related to treatment.

    Measured: Up to 5 years

Secondary outcomes (3)

  1. Overall Survival

    Overall survival time is defined as the time from registration to the time of death due to any cause. Estimated using the method of Kaplan-Meier.

    Measured: From registration to death due to any cause, assessed up to 5 years

  2. Progression Free Survival

    Progression free survival is defined as the time from registration to the time of progression or death, whichever occurs first. Estimated using the method of Kaplan-Meier.

    Measured: From registration to documentation of disease progression, assessed up to 5 years

  3. Duration of Response

    The date at which the objective status is first noted to be either a Complete Response (CR) or Partial Response (PR) to the date progression is documented, assessed up to 5 years.

    Measured: From time of documented response to the date progression is documented, assessed up to 5 years.

Timeline

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

  1. First posted16 Mar 2009 (estimated)
  2. Study start3 Apr 2009
  3. Primary completion14 Sep 2010
  4. Study completion16 Jan 2014

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00861913
Sponsor's protocol ID
NCI-2009-01163
Other IDs
NCI-2009-01163, CDR0000637188, MAYO-MC0875, MC0875, 8218, N01CM62205, P30CA015083
Status last verified
Sep 2018
First submitted
13 Mar 2009
Last updated
16 Oct 2018

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Laboratory Biomarker Analysis, Pazopanib Hydrochloride and Pharmacological Study in people with Recurrent Melanoma and Stage IV Cutaneous Melanoma AJCC v6 and v7, run by National Cancer Institute (NCI) at 4 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?

The sponsor lists 54 inclusion and 0 exclusion criteria. 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 16 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Tumor Response Rate (time frame: Up to 5 years). The study lists 2 primary outcomes in all. 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 NCT00861913.

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 16 Oct 2018.

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