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
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|ClinicalTrials.gov Identifier: NCT01666418|
Recruitment Status : Unknown
Verified December 2014 by University of Zurich.
Recruitment status was: Active, not recruiting
First Posted : August 16, 2012
Last Update Posted : December 3, 2014
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.
Evaluation of metabolic activity in vivo
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
|Condition or disease||Intervention/treatment||Phase|
|Melanoma||Drug: Pazopanib/Paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||October 2014|
|Estimated Study Completion Date :||May 2015|
- Evaluation of metabolic activity in vivo [ Time Frame: 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).
- Determination of changes in gene expression profiling [ Time Frame: 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
- Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS) [ Time Frame: 112 days ]
- 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) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01666418
|University Hospital Zurich, Division of Dermatology|
|Principal Investigator:||Reinhard Dummer, Professor MD||University Hospital Zurich, Division of Dermatology|