NCT01666418

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 16, 2012

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

October 16, 2018

Status Verified

October 1, 2018

Enrollment Period

2.2 years

First QC Date

August 8, 2012

Last Update Submit

October 11, 2018

Conditions

Melanoma

Outcome Measures

Primary Outcomes (1)

  • Evaluation of metabolic activity in vivo

    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).

    84 days ( Baseline, Day 10, Day 70)

Secondary Outcomes (3)

  • Determination of changes in gene expression profiling

    84 days ( Baseline, Day 10, Day 70)

  • Evaluation of the antitumor activity of the combination in terms of progression free survival (PFS)

    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)

    84 days ( Baseline, Day 10, Day 70)

Study Arms (1)

Pazopanib/Paclitaxel

OTHER
Drug: Pazopanib/Paclitaxel

Interventions

Pazopanib/PaclitaxelDRUG
Pazopanib/Paclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Division of Dermatology

Zurich, Switzerland

Location

MeSH Terms

Conditions

Melanoma

Interventions

pazopanibPaclitaxel

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Reinhard Dummer, Professor MD

    University Hospital Zurich, Division of Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 16, 2012

Study Start

August 1, 2012

Primary Completion

October 1, 2014

Study Completion

May 1, 2015

Last Updated

October 16, 2018

Record last verified: 2018-10

Locations

CH(1)