Glioblastoma MultiformePhase 2NCT02047214
Safety & Efficacy Study of TPI 287 + Avastin in Adults With Glioblastoma That Progressed Following Prior Avastin Therapy
A Phase 2 study testing TPI 287 and Bevacizumab in people with Glioblastoma Multiforme, run by Cortice Biosciences, Inc. at 11 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide (TMZ) therapy and that has progressed following prior… 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?
- TPI 287 and Bevacizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2014to Dec 2015
- 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 proven GBM
- Disease progression following radiation \& TMZ
- 1st progression of GBM on bevacizumab-containing regimen or within 8 weeks of discontinuing bevacizumab. In either case, must have received a minimum of 8 weeks (4 infusions) of bevacizumab.
- Baseline MRI must be performed after subject signs informed consent form (ICF), within 17 days of Day 1, \& on steroid dosage that has been stable or decreasing for at least 5 days
- Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks have elapsed from date of surgery \& subject has recovered from surgery
- Life expectancy >12 weeks
Show all 20Show fewer
- Eighteen years old or older
- KPS equal to or greater than 70
- Recovered from toxic effects of prior therapy to < Grade 2 toxicity per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) prior to Day 1. Minimum duration required between prior therapy \& Day 1 is:
- At least 12 weeks from completion of radiation therapy except if there is unequivocal evidence for tumor recurrence in which case at least 4 weeks
- 4 weeks from prior cytotoxic therapy
- 4 weeks from prior experimental drug
- 6 weeks from nitrosoureas
- 3 weeks from procarbazine
- 1 week for non-cytotoxic agents (e.g., interferon, tamoxifen, \& cis-retinoic acid)
- 14 days from last dose of bevacizumab
- Adequate bone marrow function [absolute neutrophil count (ANC) > 1,500/mm3 \& platelet count of > 100,000/mm3], adequate liver function [alanine aminotransferase (ALT) \& aspartate aminotransferase (AST) <3 x upper limit normal (ULN), alkaline phosphatase <2 x ULN, \& total bilirubin <1.5 mg/dL], \& adequate renal function (BUN \& creatinine <1.5 x ULN)
- Minimum hemoglobin of 9 g/dL
- Males \& women of childbearing potential must agree to abstain from sex or use an adequate method of contraception for duration of study \& for 6 months after last dose of study drug
- Signed \& dated ICF prior to Screening evaluations
Who cannot join
- Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal dissemination, gliomatosis cerebri or infratentorial tumor
- Evidence or suspicion of disease metastatic to sites remote from supratentorial brain
- Prior treatment with anti-vascular endothelial growth factor (VEGF) drugs other than bevacizumab
- Prior treatment with tyrosine-kinase inhibitors targeting VEGF, platelet-derived growth factor, fibroblast growth factor, tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2 (TIE-2), or angiopoietin (or their receptors)
- Prior treatment with histone deacetylase inhibitors or mammalian target of rapamycin (mTOR) inhibitors
- Prior treatment with TPI 287
Show all 34Show fewer
- Treatment with Enzyme-Inducing Anti-Epileptic Drugs within 2 weeks prior to Day 1
- Treatment with drugs or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 3A4 or 2C8 within 2 weeks prior to Day 1
- Received more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, dose counts against total dose limit.
- Prior taxane, vincristine, or other microtubule inhibitor chemotherapies for treatment of GBM or other malignancy
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during course of study
- Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
- Any condition, including the presence of clinically significant laboratory abnormalities, which places subject at unacceptable risk if he/she were to participate in study or confounds the ability to interpret data from study, including:
- Active infection including known AIDS or Hepatitis C or with a fever ≥38.5°C within 3 days prior to study enrollment
- Diseases or conditions that obscure toxicity or dangerously alter drug metabolism
- Serious intercurrent medical illness (e.g., symptomatic congestive heart failure)
- Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent subject from providing informed consent
- Inadequately controlled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg)
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association Grade II or greater congestive heart failure
- History of myocardial infarction or unstable angina within 6 months prior to Day 1
- History of stroke or transient ischemic attack within 6 months prior to Day 1
- Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
- History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
- Evidence of bleeding diathesis or significant coagulopathy (in absence of therapeutic anticoagulation)
- Grade 2 or higher peripheral neuropathy per NCI CTCAE
- History of abdominal fistula or gastrointestinal perforation within 6 months prior to Day 1
- Serious, non-healing wound, active ulcer, or untreated bone fracture
- Proteinuria at Screening. Subjects with a urine dipstick protein ≥ 2+ at Screening will undergo a 24-hour urine collection and must demonstrate ≤ 1g of protein in 24 hours to be eligible.
- Known hypersensitivity to any inactive ingredient of bevacizumab
- Known hypersensitivity to any inactive ingredient of TPI 287
- Pregnancy (positive pregnancy test) or lactation
- Inability to comply with protocol or study procedures
- Previously or currently enrolled in Protocol No. TPI-287-17
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35249
University of Virginia Health System
Charlottesville, Virginia, 22908
Northwestern Medical Faculty Foundation
Chicago, Illinois, 60611
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601
Memorial Hermann Hospital
Houston, Texas, 77030
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Rochester Medical Center
Rochester, New York, 14642
Swedish Neuroscience Institute
Seattle, Washington, 98122
Washington University, School of Medicine
St Louis, Missouri, 63110
H Lee Moffitt Cancer Center and Research Institute, Inc.
Tampa, Florida, 33612
About this study
Official title: Phase 2 Dose-Escalation Study of TPI 287 in Combination With Bevacizumab in Adults With Recurrent or Progressive Glioblastoma Following a Bevacizumab-Containing Regimen
The purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide (TMZ) therapy and that has progressed following prior bevacizumab therapy.
Read the detailed description
This multi-center trial is a phase 2, dose-escalation study of the safety, tolerability (MTD), and efficacy of TPI 287 in combination with bevacizumab in subjects who have GBM that has progressed following prior radiation and TMZ therapy and that has progressed following prior bevacizumab therapy.
All subjects will be administered TPI 287 as an intravenous (IV) infusion (target duration of 1 hour) once every 3 weeks (Days 1 and 22 of a 42-day cycle) and bevacizumab as a 30 to 90 minute IV infusion once every 2 weeks (Days 1, 15, and 29 of the 42-day cycle). The subsequent cycle will start 3 weeks after the last TPI 287 infusion and 2 weeks after the last bevacizumab infusion, maintaining the once every 3 week and once every 2 week schedule, respectively.
The dose of TPI 287 will be escalated in sequential dose cohorts of 3 to 6 subjects, while the dose of bevacizumab remains constant (10 mg/kg). The initial cohort of 3 subjects will be treated at a TPI 287 dose of 140 mg/m2 (dose level 0). The next dose level will be 160 mg/m2 (dose level 1). Subsequent dose levels will be increased in increments of 10 mg/m2 (i.e., dose level 2 = 170 mg/m2, dose level 3 = 180 mg/m2, etc.). If dose de-escalation below the starting dose level is required, dose levels of 130 and 120 mg/m2 will be used. Twelve (12) to 18 subjects are planned for enrollment during the dose escalation phase, depending on the number of subjects that experience dose limiting toxicities (DLTs).
Once the MTD is identified, 6 additional subjects will be enrolled at the MTD (for a total of 12) to better characterize the toxicity profile at this level.
Dose modifications and delays will be required as described in the protocol. Subjects may continue on treatment unless they meet one or more of the discontinuation criteria outlined in the protocol. Subjects who are discontinued prior to completing Cycle 1 for any reason other than toxicity will be replaced.
Adverse events (AEs) and concomitant medications will be monitored throughout the study. Subjects will be given a diary to record any AEs or concomitant medications taken between visits. Additional safety evaluations will include physical examination (including neurologic examination), Karnofsky performance status (KPS), weight (body surface area, BSA), vital signs, hematology, serum chemistry, and urinalysis.
Efficacy evaluations will include magnetic resonance imaging [MRI, including both pre and post-gadolinium T1-weighted scans and T2/fluid attenuated inversion recovery (FLAIR) images], corticosteroid usage, and neurologic status (as measured by neurologic exam and KPS).
- Conditions
- Glioblastoma Multiforme
- Being tested
- TPI 287, Bevacizumab
- Keywords
- Glioblastoma multiforme, Glioblastoma, Radiotherapy, Temozolomide, TPI 287, Taxoid, Avastin, Bevacizumab
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPI 287Drug
Also called TPI-287, NBT 287
TPI 287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class. TPI 287 is an Investigational Drug.
BevacizumabDrug
Also called Avastin
Avastin (bevacizumab) is an FDA approved drug indicated for multiple cancers, including as a single agent for GBM for adult patients with progressive disease following prior therapy. Single agent effectiveness is based on improvement in objective response rate; no data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab.
| Study group | Role | What they receive |
|---|---|---|
| TPI 287 + bevacizumab | Experimental | All subjects will be administered TPI 287 as an IV infusion (1-hour target duration) once every 3 weeks (Days 1 and 22) and bevacizumab as a 30 to 90 minute IV infusion once every 2 weeks (Days 1, 15, and 29) of a 42-day cycle. The dose of TPI 287 will be escalated in sequential dose cohorts of 3 to 6 subjects, while the dose of bevacizumab remains constant (10 mg/kg). The planned dose escalation levels are 140, 160, 170, and 180 mg/m2; subsequent dose levels will be increased in increments of 10 mg/m2. If dose de-escalation below the starting dose level of 140 mg/m2 is required, dose levels of 130 and 120 mg/m2 will be used. Once the MTD is identified, 6 additional subjects will be enrolled at the MTD to better characterize the toxicity profile at this level. Subjects may continue on treatment unless they meet one or more of the discontinuation criteria outlined in the protocol. Receives: Drug: TPI 287; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab as measured by AEs, physical/neurologic exam, KPS, weight, vital signs, hematology, serum chemistry, & urinalysis
Measured: Continuously over study treatment through 4 weeks after last dose of study drug
MTD of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab
The MTD will be defined as the highest dose level achieved at which no more than 1 out of 6 subjects experienced a DLT that initiated within 42 days of receiving the first dose of study drug.
Measured: Within 42 days of receiving the first dose of study drug
Secondary outcomes (1)
Efficacy of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab as measured by median progression free survival (PFS), overall response rate, & PFS rate at 4 & 6 months (PFS4 & PFS6)
The Response Assessment in Neuro-Oncology (RANO) working group recommendations for updated response criteria for high-grade gliomas (Wen et al. 2010) will be used to determine response for this trial.
Measured: Baseline & on Day 1 of each 42-day treatment cycle starting with Cycle 2, and/or as clinically indicated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Why it stopped: Due to lack of clinical benefit in the 17 subjects enrolled in the trial to date
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
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cortice Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel A. Goldlust, M.D., Principal investigator, John Theurer Cancer Center at Hackensack University Medical CenterLouis B. Nabors, III, M.D., Principal investigator, University of Alabama at BirminghamSigmund Hsu, M.D., Principal investigator, Memorial Hermann HospitalNimish Mohile, M.D., Principal investigator, University of RochesterSolmaz Sahebjam, M.D., Principal investigator, H Lee Moffitt Cancer Center and Research Institute, Inc.Tara L. Benkers, M.D., Principal investigator, Swedish Neuroscience InstitutePriya Kumthekar, M.D., Principal investigator, Northwestern UniversityJian Campian, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047214
- Sponsor's protocol ID
- TPI-287-18
- Status last verified
- Jan 2018
- First submitted
- 24 Jan 2014
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Dose-Escalation Study of TPI 287 in Combination With Bevacizumab in Adults With Recurrent or Progressive Glioblastoma Following a Bevacizumab-Containing Regimen
- ClinicalTrials.gov ID
- NCT02047214
- Acronym / sponsor ID
- TPI-287-18
- Conditions
- Glioblastoma Multiforme
- Keywords
- Glioblastoma multiforme, Glioblastoma, Radiotherapy, Temozolomide, TPI 287, Taxoid, Avastin, Bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to lack of clinical benefit in the 17 subjects enrolled in the trial to date
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Cortice Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Jan 2014 (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 purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide (TMZ) therapy and that has progressed following prior bevacizumab therapy.
Detailed description
This multi-center trial is a phase 2, dose-escalation study of the safety, tolerability (MTD), and efficacy of TPI 287 in combination with bevacizumab in subjects who have GBM that has progressed following prior radiation and TMZ therapy and that has progressed following prior bevacizumab therapy.
All subjects will be administered TPI 287 as an intravenous (IV) infusion (target duration of 1 hour) once every 3 weeks (Days 1 and 22 of a 42-day cycle) and bevacizumab as a 30 to 90 minute IV infusion once every 2 weeks (Days 1, 15, and 29 of the 42-day cycle). The subsequent cycle will start 3 weeks after the last TPI 287 infusion and 2 weeks after the last bevacizumab infusion, maintaining the once every 3 week and once every 2 week schedule, respectively.
The dose of TPI 287 will be escalated in sequential dose cohorts of 3 to 6 subjects, while the dose of bevacizumab remains constant (10 mg/kg). The initial cohort of 3 subjects will be treated at a TPI 287 dose of 140 mg/m2 (dose level 0). The next dose level will be 160 mg/m2 (dose level 1). Subsequent dose levels will be increased in increments of 10 mg/m2 (i.e., dose level 2 = 170 mg/m2, dose level 3 = 180 mg/m2, etc.). If dose de-escalation below the starting dose level is required, dose levels of 130 and 120 mg/m2 will be used. Twelve (12) to 18 subjects are planned for enrollment during the dose escalation phase, depending on the number of subjects that experience dose limiting toxicities (DLTs).
Once the MTD is identified, 6 additional subjects will be enrolled at the MTD (for a total of 12) to better characterize the toxicity profile at this level.
Dose modifications and delays will be required as described in the protocol. Subjects may continue on treatment unless they meet one or more of the discontinuation criteria outlined in the protocol. Subjects who are discontinued prior to completing Cycle 1 for any reason other than toxicity will be replaced.
Adverse events (AEs) and concomitant medications will be monitored throughout the study. Subjects will be given a diary to record any AEs or concomitant medications taken between visits. Additional safety evaluations will include physical examination (including neurologic examination), Karnofsky performance status (KPS), weight (body surface area, BSA), vital signs, hematology, serum chemistry, and urinalysis.
Efficacy evaluations will include magnetic resonance imaging [MRI, including both pre and post-gadolinium T1-weighted scans and T2/fluid attenuated inversion recovery (FLAIR) images], corticosteroid usage, and neurologic status (as measured by neurologic exam and KPS).
Study design
- Primary purpose
- Treatment
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TPI 287 + bevacizumab | Experimental | Drug: TPI 287, Drug: BevacizumabAll subjects will be administered TPI 287 as an IV infusion (1-hour target duration) once every 3 weeks (Days 1 and 22) and bevacizumab as a 30 to 90 minute IV infusion once every 2 weeks (Days 1, 15, and 29) of a 42-day cycle. The dose of TPI 287 will be escalated in sequential dose cohorts of 3 to 6 subjects, while the dose of bevacizumab remains constant (10 mg/kg). The planned dose escalation levels are 140, 160, 170, and 180 mg/m2; subsequent dose levels will be increased in increments of 10 mg/m2. If dose de-escalation below the starting dose level of 140 mg/m2 is required, dose levels of 130 and 120 mg/m2 will be used. Once the MTD is identified, 6 additional subjects will be enrolled at the MTD to better characterize the toxicity profile at this level. Subjects may continue on treatment unless they meet one or more of the discontinuation criteria outlined in the protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically proven GBM
- Disease progression following radiation \& TMZ
- 1st progression of GBM on bevacizumab-containing regimen or within 8 weeks of discontinuing bevacizumab. In either case, must have received a minimum of 8 weeks (4 infusions) of bevacizumab.
- Baseline MRI must be performed after subject signs informed consent form (ICF), within 17 days of Day 1, \& on steroid dosage that has been stable or decreasing for at least 5 days
- Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks have elapsed from date of surgery \& subject has recovered from surgery
Key exclusion criteria (34 listed)
- Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal dissemination, gliomatosis cerebri or infratentorial tumor
- Evidence or suspicion of disease metastatic to sites remote from supratentorial brain
- Prior treatment with anti-vascular endothelial growth factor (VEGF) drugs other than bevacizumab
- Prior treatment with tyrosine-kinase inhibitors targeting VEGF, platelet-derived growth factor, fibroblast growth factor, tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2 (TIE-2), or angiopoietin (or their receptors)
- Prior treatment with histone deacetylase inhibitors or mammalian target of rapamycin (mTOR) inhibitors
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 |
|---|---|---|
| TPI 287Also: TPI-287, NBT 287TPI 287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class. TPI 287 is an Investigational Drug. | Drug | TPI 287 + bevacizumab |
| BevacizumabAlso: AvastinAvastin (bevacizumab) is an FDA approved drug indicated for multiple cancers, including as a single agent for GBM for adult patients with progressive disease following prior therapy. Single agent effectiveness is based on improvement in objective response rate; no data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab. | Drug | TPI 287 + bevacizumab |
Primary outcome
Safety of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab as measured by AEs, physical/neurologic exam, KPS, weight, vital signs, hematology, serum chemistry, & urinalysis
Time frame: Continuously over study treatment through 4 weeks after last dose of study drug
MTD of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab
Time frame: Within 42 days of receiving the first dose of study drug
The MTD will be defined as the highest dose level achieved at which no more than 1 out of 6 subjects experienced a DLT that initiated within 42 days of receiving the first dose of study drug.
1 secondary outcome
Efficacy of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab as measured by median progression free survival (PFS), overall response rate, & PFS rate at 4 & 6 months (PFS4 & PFS6)
Time frame: Baseline & on Day 1 of each 42-day treatment cycle starting with Cycle 2, and/or as clinically indicated
Results and safety
The study was stopped early (reason given: Due to lack of clinical benefit in the 17 subjects enrolled in the trial to date). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
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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.
Samuel A. Goldlust, M.D. principal investigator
John Theurer Cancer Center at Hackensack University Medical Center
Louis B. Nabors, III, M.D. principal investigator
University of Alabama at Birmingham
Sigmund Hsu, M.D. principal investigator
Memorial Hermann Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TPI 287 and Bevacizumab in people with Glioblastoma Multiforme, run by Cortice Biosciences, Inc. at 11 sites in United States.
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 20 inclusion and 34 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 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in 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: Due to lack of clinical benefit in the 17 subjects enrolled in the trial to date). 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?
Safety of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab as measured by AEs, physical/neurologic exam, KPS, weight, vital signs, hematology, serum chemistry, & urinalysis (time frame: Continuously over study treatment through 4 weeks after last dose of study drug). The study lists 2 primary outcomes in all. 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 31 Jan 2018; AzTrials last refreshed its copy on 8 Nov 2026.