Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma

August 4, 2010 updated by: Thallion Pharmaceuticals

A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma

The objective of this study is to assess the efficacy and safety of TLN-232 used to treat patients with metastatic melanoma that recur/progress after receiving first line systemic therapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada
        • Juravinski Cancer Centre
      • Toronto, Ontario, Canada
        • Princess Margaret Hospital
    • Quebec
      • Montreal, Quebec, Canada
        • Hopital Notre-Dame du CHUM
  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
        • Fox Chase Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically confirmed stage IV (M1a, M1b, and M1c) unresectable metastatic melanoma (cutaneous, mucosal or acral lentiginous)
  • First progression after treatment by one first line systemic therapy for metastatic melanoma (immunotherapy or targeted therapy or chemotherapy or any combination of them)
  • Measurable recurrent/progressive disease by radiological scan ≤ 21 days prior to Day 1, Cycle 1
  • Age ≥ 18 years
  • ECOG ≤ 2

  • Normal organ and marrow function as defined below:

    • Leukocytes ≥2.5 x 109/L
    • Absolute neutrophil count ≥1.5 x 109/L
    • Platelets ≥100 x 109/L
    • Hemoglobin ≥100 g/L (10g/dL)
    • Total bilirubin ≤1.5 X institutional ULN
    • AST(SGOT)/ALT(SGPT) ≤2.5 X institutional ULN
    • Creatinine ≤1.5 X institutional ULN

Exclusion Criteria:

  • Patients with a life expectancy ≤ 16 weeks
  • Patients with ocular melanoma
  • Patients with symptomatic and/or unstable brain metastasis during the last 3 months (90 days) prior to Day 1, Cycle 1
  • Patients with a history of allergic reactions or hypersensitivity to somatostatin analogues
  • Patients with a documented history of HIV, active hepatitis B or C infection
  • Female patients who are pregnant or lactating
  • Patients who are receiving hormonal therapy (with the exception of hormone replacement therapy and hormonal contraceptives), systemic steroids, immunosuppressive therapy or coumadin (low molecular weight heparin is permitted)
  • Patients with grade ≥2 peripheral neuropathy (CTCAE criteria)
  • Patients in whom a proper central line cannot be established

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single-Arm
Drug: TLN-232
21 day continuous IV administration of TLN-232 followed by a 7-day recovery period
Other Names:
  • Formerly CAP-232

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To assess the efficacy of TLN-232 in patients with recurrent metastatic melanoma measured by overall response rate at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1).
Time Frame: Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Complete response, partial response or stable disease at 16 weeks from date of initial infusion of TLN-232 (Day 1, Cycle 1)

Secondary Outcome Measures

Outcome Measure
Time Frame
To examine the safety and tolerability of TLN-232 in patients with recurrent metastatic melanoma
Time Frame: Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1)
Maximum 13 months from date of initial infusion of TLN-232 (Day 1, Cycle 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Thallion Pharmaceuticals

Investigators

  • Principal Investigator: David Hogg, MD, Princess Margaret Hospital, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

August 13, 2008

First Submitted That Met QC Criteria

August 13, 2008

First Posted (Estimate)

August 14, 2008

Study Record Updates

Last Update Posted (Estimate)

August 5, 2010

Last Update Submitted That Met QC Criteria

August 4, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLN-232-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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