GlioblastomaPhase 2NCT02342379
TH-302 in Combination With Bevacizumab for Glioblastoma
A Phase 2 study testing Bevacizumab and TH-302 in people with Glioblastoma, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease progression. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Bevacizumab and TH-302
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2015to 4 Dec 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- At least 18 years of age
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- Histologically confirmed glioblastoma
- Progression following both standard combined modality treatment with radiation and temozolomide chemotherapy, as well as bevacizumab
- Recovered from toxicities of prior therapy to grade 0 or 1
- ECOG performance status ≤ 2
Show all 17Show fewer
- Life expectancy of at least 3 months
- Acceptable liver function:
- Bilirubin ≤ 1.5 times upper limit of normal
- AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN);
- Acceptable renal function:
- Serum creatinine ≤ULN
- Acceptable hematologic status (without hematologic support):
- ANC ≥1500 cells/uL
- Platelet count ≥100,000/uL
- Hemoglobin ≥9.0 g/dL
- All women of childbearing potential must have a negative serum pregnancy test and male and female subjects must agree to use effective means of contraception (surgical sterilization or the use or barrier contraception with either a condom or diaphragm in conjunction with spermicidal gel or an IUD) with their partner from entry into the study through 6 months after the last dose
Who cannot join
- The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
- The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage, punctate hemorrhage, or hemosiderin are eligible.
- The subject is unable to undergo MRI scan (eg, has pacemaker).
- The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
- The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug.
- The subject has evidence of wound dehiscence
Show all 26Show fewer
- Severe chronic obstructive or other pulmonary disease with hypoxemia (requires supplementary oxygen, symptoms due to hypoxemia or oxygen saturation <90% by pulse oximetry after a 2 minute walk) or in the opinion of the investigator any physiological state likely to cause normal tissue hypoxia
- The subject is pregnant or breast-feeding.
- The subject has serious intercurrent illness, such as:
- hypertension (two or more blood pressure [BP] readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment
- non-healing wound, ulcer, or bone fracture
- significant cardiac arrhythmias
- untreated hypothyroidism
- uncontrolled active infection
- symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug
- myocardial infarction, stroke, transient ischemic attack within 6 months
- gastrointestinal perforation, abdominal fistula, intra- abdominal abscess within 1 year
- history or clinical evidence of pancreatitis within 2 years
- The subject has inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- The subject has received any of the following prior anticancer therapy:
- Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
- Non-bevacizumab systemic therapy (including investigational agents and small-molecule kinase inhibitors) or non-cytotoxic hormonal therapy (eg, tamoxifen) within 7 days or 5 half-lives, whichever is shorter, prior first dose of study drug
- Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
- Nitrosoureas or mitomycin C within 42 days, or metronomic/protracted low-dose chemotherapy within 14 days, or other cytotoxic chemotherapy within 28 days, prior to first dose of study drug
- Prior treatment with carmustine wafers
- Prior treatment with TH-302
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center
San Antonio, Texas, 78229
About this study
Official title: A Phase 2, Investigator Initiated Study to Determine the Safety and Efficacy of TH-302 in Combination With Bevacizumab for Glioblastoma Following Bevacizumab Failure
Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease progression.
- Conditions
- Glioblastoma
- Being tested
- Bevacizumab, TH-302
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
Also called Avastin
10mg/kg
TH-302Drug
Also called MSC2491899A
670mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Bevacizumab and TH-302 | Experimental | Patients will be treated with combination of bevacizumab and TH-302. Receives: Drug: Bevacizumab; Drug: TH-302 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Adverse Events
Safety lab tests and adverse event assessment
Measured: 4 months
Secondary outcomes (1)
Progression Free Survival
Progression of disease by RANO criteria:
The RANO criteria divides response into four types of response based on imaging and clinical features
- complete response
- partial response
- stable disease
- progression
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startMay 2015
- Primary completion4 Jan 2019
- Study completion4 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- 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
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew Brenner, MD, Principal investigator, University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342379
- Sponsor's protocol ID
- CTRC 12-0105
- Other IDs
- HSC20130212H
- Status last verified
- Apr 2020
- First submitted
- 14 Jan 2015
- Last updated
- 10 Apr 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Investigator Initiated Study to Determine the Safety and Efficacy of TH-302 in Combination With Bevacizumab for Glioblastoma Following Bevacizumab Failure
- ClinicalTrials.gov ID
- NCT02342379
- Acronym / sponsor ID
- CTRC 12-0105
- Conditions
- Glioblastoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 4 Jan 2019 (actual)
- Study completion
- 4 Dec 2019 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 10 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Dual center, single arm, two-stage, non-blinded, prospective study of combination therapy bevacizumab at 10mg/kg and TH-302 at 670mg/m2 every 2 weeks (6 week cycle) until disease progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bevacizumab and TH-302 | Experimental | Drug: Bevacizumab, Drug: TH-302Patients will be treated with combination of bevacizumab and TH-302. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- At least 18 years of age
- Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB/Ethics Committee
- Histologically confirmed glioblastoma
- Progression following both standard combined modality treatment with radiation and temozolomide chemotherapy, as well as bevacizumab
- Recovered from toxicities of prior therapy to grade 0 or 1
Key exclusion criteria (26 listed)
- The subject is receiving warfarin (or other coumarin derivatives) and is unable to switch to low molecular weight heparin (LMWH) before the first dose of study drug.
- The subject has evidence of acute intracranial or intratumoral hemorrhage either by MRI or computerized tomography (CT) scan. Subjects with resolving hemorrhage, punctate hemorrhage, or hemosiderin are eligible.
- The subject is unable to undergo MRI scan (eg, has pacemaker).
- The subject has received enzyme-inducing anti-epileptic agents within 14 days of study drug (eg, carbamazepine, phenytoin, phenobarbital, primidone).
- The subject has not recovered to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 Grade ≤ 1 from AEs (except alopecia, anemia and lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other medications that were administered prior to study drug.
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 |
|---|---|---|
| BevacizumabAlso: Avastin10mg/kg | Drug | Bevacizumab and TH-302 |
| TH-302Also: MSC2491899A670mg/m2 | Drug | Bevacizumab and TH-302 |
Primary outcome
Number of Patients With Adverse Events
Time frame: 4 months
Safety lab tests and adverse event assessment
1 secondary outcome
Progression Free Survival
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Glioblastoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Active, not recruitingPhase 1
Oral Gallium Maltolate for the Treatment of Relapsed and Refractory Glioblastoma
Glioblastoma
RecruitingPhase 1/2
PLX038 in Primary Central Nervous System Tumors Containing MYC or MYCN Amplifications
Glioma, Medulloblastoma
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.
Andrew Brenner, MD principal investigator
University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center
2 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 Bevacizumab and TH-302 in people with Glioblastoma, run by The University of Texas Health Science Center at San Antonio at 2 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 17 inclusion and 26 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: finished, as of the sponsor's last update on 10 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 10 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Adverse Events (time frame: 4 months). 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 10 Apr 2020.