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
- 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
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Pazopanib/Paclitaxel Pazopanib/Paclitaxel -
- Primary Outcome Measures
Name Time Method Evaluation of metabolic activity in vivo 84 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
Name Time Method Determination of changes in gene expression profiling 84 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
🇨ðŸ‡Zurich, Switzerland