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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

Phase 2
Completed
Conditions
Melanoma
Interventions
Drug: Pazopanib/Paclitaxel
Registration Number
NCT01666418
Lead Sponsor
University of Zurich
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
19
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Pazopanib/PaclitaxelPazopanib/Paclitaxel-
Primary Outcome Measures
NameTimeMethod
Evaluation of metabolic activity in vivo84 days ( Baseline, Day 10, Day 70)

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).

Secondary Outcome Measures
NameTimeMethod
Determination of changes in gene expression profiling84 days ( Baseline, Day 10, Day 70)

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

Changes in S100 and LDH during therapy at the same time points as FDG-PET/CT (a combined serum measurement of S100 and LDH)84 days ( Baseline, Day 10, Day 70)
Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS)112 days

Trial Locations

Locations (1)

University Hospital Zurich, Division of Dermatology

🇨🇭

Zurich, Switzerland

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