The primary objective of this study is to determine the objective response rate (complete and partial response) for patients who receive LY573636 after one prior systemic treatment for unresectable or metastatic melanoma.

Official Title

A Phase 2 Study of LY573636 Administered as an Intravenous Infusion on Day 1 of a 21-Day Cycle as Second-Line Treatment in Patients With Unresectable or Metastatic Melanoma

Conditions

Malignant Melanoma

Study Type

Interventional

Study Design

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study

Further Details

Primary Outcome Measures:

  • Objective response rate (complete response and partial response). CT-scans will be performed before the first dose and then after every other cycle of treatment.

Secondary Outcome Measures:

  • Progression-free survival
  • Clinical response rate (complete response plus partial response plus stable disease)
  • Pharmacokinetics
  • Overall survival time
  • Duration of overall objective response
  • Duration of stable disease
  • Safety
  • Health-related Quality of Life
  • Assessments will be completed at every 21-day cycle during active treatment and every 60-days during the post-treatment follow-up period.

Study Start

November 2006; Expected completion: February 2008

Eligibility & Criteria

  • Ages Eligible for Study: 18 Years and above
  • Genders Eligible for Study: Both

Inclusion Criteria:

  • Diagnosis of malignant melanoma that is unresectable or metastatic (Stage III or IV)
  • Have received 1 previous systemic treatment regimen for unresectable or metastatic melanoma. An immunotherapy or antibody-based regimen (including vaccination-based treatments) is not counted as a prior treatment regimen for determining study eligibility, unless it was combined with a chemotherapeutic or targeted anti-cancer drug.
  • Have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, immunotherapy, or other investigational therapy for at least 30 days

Exclusion Criteria:

  • Serious pre-existing medical conditions
  • Have received two or more previous treatment regimens for unresectable or metastatic melanoma
  • Have a second primary cancer (unless disease-free to more than 2 years)
  • Active treatment with Warfarin (Coumadin)
  • Primary ocular or mucosal melanoma

Total Enrolment

50

Contact Details

Australian Locations:

  • Coffs Harbour, New South Wales, 2450, Australia; Recruiting
  • Waratah, New South Wales, 2298, Australia; Recruiting
  • Wollongong, New South Wales, 2500, Australia; Recruiting
  • Adelaide, South Australia, 5000, Australia; Recruiting
  • Ashford, South Australia, 5035, Australia; Recruiting
  • Box Hill, Victoria, 3128, Australia; Not yet recruiting
  • Nedlands, Western Australia, 6009, Australia; Recruiting

See Lilly Clinical Trials Registry for more information.