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

This study has been terminated.
(License termination.)
Sponsor:
Information provided by:
Thallion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00735332
First received: August 13, 2008
Last updated: August 4, 2010
Last verified: August 2010

August 13, 2008
August 4, 2010
August 2008
December 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00735332 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of TLN-232 in Patients With Recurring Metastatic Melanoma
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.

Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Melanoma
Drug: TLN-232
21 day continuous IV administration of TLN-232 followed by a 7-day recovery period
Other Name: Formerly CAP-232
Experimental: Single-Arm
Intervention: Drug: TLN-232
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
49
October 2010
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00735332
TLN-232-202
No
Didier Reymond, MD / Executive Vice-President Clinical Development, Thallion Pharmaceuticals Inc.
Thallion Pharmaceuticals
Not Provided
Principal Investigator: David Hogg, MD Princess Margaret Hospital, Toronto
Thallion Pharmaceuticals
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP