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TH-302 in Combination With Bevacizumab for Glioblastoma

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ClinicalTrials.gov Identifier: NCT02342379
Recruitment Status : Active, not recruiting
First Posted : January 19, 2015
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew Brenner, The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE January 14, 2015
First Posted Date  ICMJE January 19, 2015
Last Update Posted Date October 26, 2018
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 16, 2015)
Number of patients with Adverse events [ Time Frame: 4 months ]
Safety lab tests and adverse event assessment
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02342379 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 16, 2015)
Progression free survival [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TH-302 in Combination With Bevacizumab for Glioblastoma
Official Title  ICMJE A Phase 2, Investigator Initiated Study to Determine the Safety and Efficacy of TH-302 in Combination With Bevacizumab for Glioblastoma Following Bevacizumab Failure
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Drug: Bevacizumab
    10mg/kg
    Other Name: Avastin
  • Drug: TH-302
    670mg/m2
    Other Name: MSC2491899A
Study Arms  ICMJE Experimental: Bevacizumab and TH-302
Patients will be treated with combination of bevacizumab and TH-302.
Interventions:
  • Drug: Bevacizumab
  • Drug: TH-302
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: August 7, 2017)
35
Original Estimated Enrollment  ICMJE
 (submitted: January 16, 2015)
33
Estimated Study Completion Date  ICMJE July 2019
Estimated Primary Completion Date July 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02342379
Other Study ID Numbers  ICMJE CTRC 12-0105
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew Brenner, The University of Texas Health Science Center at San Antonio
Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Brenner, MD University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP