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TH-302 in Combination With Bevacizumab for Glioblastoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02342379
Recruitment Status : Completed
First Posted : January 19, 2015
Results First Posted : April 10, 2020
Last Update Posted : April 10, 2020
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Brief 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.

Condition or disease Intervention/treatment Phase
Glioblastoma Drug: Bevacizumab Drug: TH-302 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Actual Primary Completion Date : January 4, 2019
Actual Study Completion Date : December 4, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab

Arm Intervention/treatment
Experimental: Bevacizumab and TH-302
Patients will be treated with combination of bevacizumab and TH-302.
Drug: Bevacizumab
10mg/kg
Other Name: Avastin

Drug: TH-302
670mg/m2
Other Name: MSC2491899A




Primary Outcome Measures :
  1. Number of Patients With Adverse Events [ Time Frame: 4 months ]
    Safety lab tests and adverse event assessment


Secondary Outcome Measures :
  1. Progression Free Survival [ Time Frame: 4 months ]

    Progression of disease by RANO criteria:

    The RANO criteria divides response into four types of response based on imaging and clinical features

    1. complete response
    2. partial response
    3. stable disease
    4. progression



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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
  • Life expectancy of at least 3 months
  • Acceptable liver function:

    1. Bilirubin ≤ 1.5 times upper limit of normal
    2. AST (SGOT) and ALT (SGPT) ≤ 3.0 times upper limit of normal (ULN);
  • Acceptable renal function:

    a. Serum creatinine ≤ULN

  • Acceptable hematologic status (without hematologic support):

    1. ANC ≥1500 cells/uL
    2. Platelet count ≥100,000/uL
    3. 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

Exclusion Criteria:

  • 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
  • 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:

    1. hypertension (two or more blood pressure [BP] readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic) despite optimal treatment
    2. non-healing wound, ulcer, or bone fracture
    3. significant cardiac arrhythmias
    4. untreated hypothyroidism
    5. uncontrolled active infection
    6. symptomatic congestive heart failure or unstable angina pectoris within 3 months prior study drug
    7. myocardial infarction, stroke, transient ischemic attack within 6 months
    8. gastrointestinal perforation, abdominal fistula, intra- abdominal abscess within 1 year
    9. 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:

    1. Non-standard radiation therapy such as brachytherapy, systemic radioisotope therapy, or intra-operative radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed
    2. 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
    3. Biologic agents (antibodies, immune modulators, vaccines, cytokines) within 21 days prior to first dose of study drug
    4. 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
    5. Prior treatment with carmustine wafers
    6. Prior treatment with TH-302

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02342379


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
United States, Texas
University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Andrew Brenner, MD University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center
  Study Documents (Full-Text)

Documents provided by The University of Texas Health Science Center at San Antonio:
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02342379    
Other Study ID Numbers: CTRC 12-0105
HSC20130212H ( Other Identifier: UT Health Science Center Institutional Review Board )
First Posted: January 19, 2015    Key Record Dates
Results First Posted: April 10, 2020
Last Update Posted: April 10, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Bevacizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors