Glioblastoma MultiformePhase 2NCT00730262
Efficacy Study of TLN-4601 in Patients With Recurring Glioblastoma Multiforme
A Phase 2 study testing TLN-4601 in people with Glioblastoma Multiforme, run by Thallion Pharmaceuticals at 8 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- TLN-4601
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesin 2 countries
- Study dates
- Aug 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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 locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Canada6 sites
Hôpital Notre-Dame du CHUM
Montreal, Quebec
Royal Victoria Hospital
Montreal, Quebec
Ottawa Health Research Institute
Ottawa, Ontario
L'Hotel-Dieu de Quebec
Québec, Quebec
Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke, Quebec
The Pencer Brain Tumor Center, Princess Margaret Hospital
Toronto, Ontario
United States2 sites
Duke University
Durham, North Carolina
Sloan-Kettering Institute for Cancer Research
New York, New York
About this study
Official title: A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme
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.
- Conditions
- Glioblastoma Multiforme
- Being tested
- TLN-4601
- Keywords
- Glioblastoma Multiforme (GBM), Phase II, Brain Cancer
- Medical subject headings
- Glioblastoma, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLN-4601Drug
Also called Formerly ECO-4601
14 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period
| Study group | Role | What they receive |
|---|---|---|
| Single-Arm | Experimental | Not described Receives: Drug: TLN-4601 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6-month progression free survival from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
Secondary outcomes (1)
To examine the safety and tolerability of TLN-4601 in patients with recurrent GBM
Measured: Maximum 13 months from date of initial infusion of TLN-4601 (Day 1, Cycle 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionApr 2010 (estimated)
- Study completionJun 2010 (estimated)
Why it stopped: Lack of efficacy
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thallion Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Warren Mason, MD, Principal investigator, The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00730262
- Sponsor's protocol ID
- TLN-4601-201
- Status last verified
- Dec 2009
- First submitted
- 6 Aug 2008
- Last updated
- 30 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of TLN-4601 in Patients With Glioblastoma Multiforme
- ClinicalTrials.gov ID
- NCT00730262
- Acronym / sponsor ID
- TLN-4601-201
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma Multiforme (GBM), Phase II, Brain Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of efficacy
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Thallion PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2008
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-Arm | Experimental | Drug: TLN-4601 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLN-4601Also: Formerly ECO-460114 day continuous IV administration of TLN-4601 at 480 mg/m2/day followed by a 7-day recovery period | Drug | Single-Arm |
Primary outcome
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)
1 secondary outcome
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)
Results and safety
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Warren Mason, MD principal investigator
The Pencer Brain Tumor Center, Princess Margaret Hospital, Toronto
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TLN-4601 in people with Glioblastoma Multiforme, run by Thallion Pharmaceuticals at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of efficacy). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2009.