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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00730262
Other study ID # TLN-4601-201
Secondary ID
Status Terminated
Phase Phase 2
First received August 6, 2008
Last updated December 29, 2009
Start date August 2008
Est. completion date June 2010

Study information

Verified date December 2009
Source Thallion Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Terminated
Enrollment 40
Est. completion date June 2010
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TLN-4601
14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period

Locations

Country Name City State
Canada Hôpital Notre-Dame du CHUM Montreal Quebec
Canada Royal Victoria Hospital Montreal Quebec
Canada Ottawa Health Research Institute Ottawa Ontario
Canada L'Hotel-Dieu de Quebec Quebec
Canada Centre Hospitalier Universitaire de Sherbrooke Sherbrooke Quebec
Canada The Pencer Brain Tumor Center, Princess Margaret Hospital Toronto Ontario
United States Duke University Durham North Carolina
United States Sloan-Kettering Institute for Cancer Research New York New York

Sponsors (1)

Lead Sponsor Collaborator
Thallion Pharmaceuticals

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
Secondary To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
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