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Clinical Trial Finder

Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT00730262
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Thallion Pharmaceuticals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Warren Mason, MD
Principal Investigator Affiliation The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma Multiforme
Arms & Interventions

Arms

Experimental: Single-Arm

Interventions

Drug: - TLN-4601

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

New York, New York

Status

Address

Sloan-Kettering Institute for Cancer Research

New York, New York,

Duke University, Durham, North Carolina

Status

Address

Duke University

Durham, North Carolina,

International Sites

Ottawa Health Research Institute, Ottawa, Ontario, Canada

Status

Address

Ottawa Health Research Institute

Ottawa, Ontario,

Toronto, Ontario, Canada

Status

Address

The Pencer Brain Tumor Center, Princess Margaret Hospital

Toronto, Ontario,

Hôpital Notre-Dame du CHUM, Montreal, Quebec, Canada

Status

Address

Hôpital Notre-Dame du CHUM

Montreal, Quebec,

Royal Victoria Hospital, Montreal, Quebec, Canada

Status

Address

Royal Victoria Hospital

Montreal, Quebec,

Sherbrooke, Quebec, Canada

Status

Address

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec,

L'Hotel-Dieu de Quebec, Quebec, Canada

Status

Address

L'Hotel-Dieu de Quebec

Quebec, ,

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