- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01666418
Pilot Study Investigating the Metabolic Activity and Transcriptional Profiling in Vivo in Tumor Biopsies in Melanoma Patients During Treatment With Pazopanib Alone and in Combination With Paclitaxel
This is an open, monocentric, pilot study to determine the metabolic activity (glucose-uptake) in vivo during monotherapy with pazopanib in comparison to combination therapy with pazopanib plus paclitaxel and to investigate the transcriptional profile of cutaneous melanoma metastasis before and during the therapy (pazopanib vs. pazopanib plus paclitaxel) in subjects with unresectable Stage III or Stage IV melanoma who have not received prior cytotoxic chemotherapy.
Primary Objective:
Evaluation of metabolic activity in vivo
Secondary Objective:
Determination of changes in gene expression profiling Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS). Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)
- Trial with medicinal product
Study Overview
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Zurich, Switzerland
- University Hospital Zurich, Division of Dermatology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
- Age ≥ 18 years
- Diagnosis of histologically or cytologically confirmed melanoma stage III or IV.
- Fresh tumor tissue must be provided for all subjects for biomarker analysis before (within 14 days prior to treatment start) and during (on day 10 of the pazopanib monotherapy and the last day of the treatment with pazopanib, day 70) treatment with investigational product (asservation in RNAlater, for kryo asservation, and for cell cultures)
- Assessable metastases (skin or superficial lymph nodes with a minimal diameter 1 cm)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ system function
Exclusion criteria:
- Prior malignancy.
- Central nervous system (CNS) metastases
- Corrected QT interval (QTc) > 480 msecs using Bazett's formula.
History of any one or more of the following cardiovascular conditions within the past 6 months:
- Cardiac angioplasty or stenting;
- Myocardial infarction;
- Unstable angina;
- Coronary artery bypass graft surgery;
- Symptomatic peripheral vascular disease;
- Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA).
- Poorly controlled hypertension
- History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
- Presence of uncontrolled infection
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding
- Evidence of active bleeding or bleeding diathesis
- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
- Prior exposure to the study drug pazopanib
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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OTHER: Pazopanib/Paclitaxel
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of metabolic activity in vivo
Time Frame: 84 days ( Baseline, Day 10, Day 70)
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The primary efficacy objective is to evaluate the metabolic activity in vivo through standardising the uptake value (SUV) in the FDG-PET/CT in comparison of the SUV between baseline, after pazopanib alone (day 10) and after pazopanib plus paclitaxel (day 70).
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84 days ( Baseline, Day 10, Day 70)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of changes in gene expression profiling
Time Frame: 84 days ( Baseline, Day 10, Day 70)
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Determination of changes in gene expression profiling on exon level in all patients with (sub)-cutaneous or superficial lymph node metastases (of melanoma) during pazopanib and pazopanib plus paclitaxel therapy in comparison to pretreatment profile
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84 days ( Baseline, Day 10, Day 70)
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Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS)
Time Frame: 112 days
|
112 days
|
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Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)
Time Frame: 84 days ( Baseline, Day 10, Day 70)
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84 days ( Baseline, Day 10, Day 70)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Melanoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- SZ10ON01
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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