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

This study has been terminated.
(License termination.)
Information provided by:
Thallion Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: August 13, 2008
Last updated: August 4, 2010
Last verified: August 2010

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.

Condition Intervention Phase
Drug: TLN-232
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase IIa Study of TLN-232 as Second-line Therapy for Patients With Metastatic Melanoma

Resource links provided by NLM:

Further study details as provided by Thallion Pharmaceuticals:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 49
Study Start Date: August 2008
Estimated Study Completion Date: October 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single-Arm Drug: TLN-232
21 day continuous IV administration of TLN-232 followed by a 7-day recovery period
Other Name: Formerly CAP-232


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00735332

United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States
Canada, Ontario
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Canada, Quebec
Hôpital Notre-Dame du CHUM
Montreal, Quebec, Canada
Sponsors and Collaborators
Thallion Pharmaceuticals
Principal Investigator: David Hogg, MD Princess Margaret Hospital, Toronto
  More Information

No publications provided

Responsible Party: Didier Reymond, MD / Executive Vice-President Clinical Development, Thallion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT00735332     History of Changes
Other Study ID Numbers: TLN-232-202
Study First Received: August 13, 2008
Last Updated: August 4, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Thallion Pharmaceuticals:
Metastatic Melanoma
Phase II
Skin Cancer

Additional relevant MeSH terms:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 17, 2014