Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme
This study has been terminated.
(Lack of efficacy)
Sponsor:
Thallion Pharmaceuticals
Information provided by:
Thallion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00730262
First received: August 6, 2008
Last updated: December 29, 2009
Last verified: December 2009
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Purpose
The objective of this study is to assess the efficacy and safety of TLN-4601 used to treat patients with Glioblastoma Multiforme(GBM) that recur/progress after receiving first line systemic therapy post surgery/radiotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme |
Drug: TLN-4601 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme |
Resource links provided by NLM:
Further study details as provided by Thallion Pharmaceuticals:
Primary Outcome Measures:
- To assess the efficacy of TLN-4601 in patients with recurrent glioblastoma multiforme (GBM) as measured by 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1). [ Time Frame: 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM [ Time Frame: Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1) ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Single-Arm |
Drug: TLN-4601
14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period
Other Name: Formerly ECO-4601
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically confirmed Glioblastoma Multiforme (GBM)
- Prior treatment with radiation and one first line systemic therapy (including temozolomide or other chemotherapy, immunotherapy, targeted therapy or combination therapies), followed by measurable and unequivocal evidence of tumor progression or recurrence
- Age ≥ 18 years
- ECOG ≤ 2
Normal organ and marrow function as defined below:
- leukocytes ≥3 x 109/L
- absolute neutrophil count ≥1.5 x 109/L
- platelets ≥100 x 109/L
- hemoglobin ≥90 g/L
- total bilirubin ≤2.5 X institutional upper limit of normal
- AST(SGOT)/ALT(SGPT) ≤2.5 X institutional upper limit of normal
- creatinine ≤1.0 X institutional upper limit of normal
Exclusion Criteria:
- Patients with a life expectancy < 12 weeks
- Patients with a documented history of HIV, active hepatitis B or C infections
- Female patients who are pregnant or lactating
- Patients in whom a proper central line (Portacath-like device) cannot be established
- Patients with a known hypersensitivity to farnesylated dibenzodiazepinone or polysorbate 80
- Patients with uncontrolled hypotension
- Patients with concomitant therapy of therapeutic coumadin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730262
Locations
| United States, New York | |
| Sloan-Kettering Institute for Cancer Research | |
| New York, New York, United States | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States | |
| Canada, Ontario | |
| Ottawa Health Research Institute | |
| Ottawa, Ontario, Canada | |
| The Pencer Brain Tumor Center, Princess Margaret Hospital | |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| Hôpital Notre-Dame du CHUM | |
| Montreal, Quebec, Canada | |
| Royal Victoria Hospital | |
| Montreal, Quebec, Canada | |
| Centre Hospitalier Universitaire de Sherbrooke | |
| Sherbrooke, Quebec, Canada | |
| Canada | |
| L'Hotel-Dieu de Quebec | |
| Quebec, Canada | |
Sponsors and Collaborators
Thallion Pharmaceuticals
Investigators
| Principal Investigator: | Warren Mason, MD | The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto |
More Information
No publications provided
| Responsible Party: | Didier Reymond, MD / Vice-President Medical and Clinical Affairs, Thallion Pharmaceuticals Inc. |
| ClinicalTrials.gov Identifier: | NCT00730262 History of Changes |
| Other Study ID Numbers: | TLN-4601-201 |
| Study First Received: | August 6, 2008 |
| Last Updated: | December 29, 2009 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada Canada: Ethics Review Committee |
Keywords provided by Thallion Pharmaceuticals:
|
Glioblastoma Multiforme (GBM) Phase II Brain Cancer |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors |
Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on May 19, 2013