Know Cancer

forgot password

Phase 2
18 Years
Open (Enrolling)

Thank you

Trial Information

Inclusion Criteria

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of metabolic activity in vivo

Outcome Description:

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).

Outcome Time Frame:

84 days ( Baseline, Day 10, Day 70)

Safety Issue:


Principal Investigator

Reinhard Dummer, Professor MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospital Zurich, Division of Dermatology


Switzerland: Swissmedic

Study ID:




Start Date:

August 2012

Completion Date:

December 2013

Related Keywords:

  • Melanoma
  • Melanoma