Clinical Trials /

TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma

NCT03032484

Description:

Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone.

Related Conditions:
  • Astrocytoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma
  • Official Title: A Phase 2 Investigator Initiated Study to Determine the Efficacy and Safety of TVB- 2640 in Combination With Bevacizumab in Patients With First Relapse of High Grade Astrocytoma

Clinical Trial IDs

  • ORG STUDY ID: CTMS# 16-0136
  • NCT ID: NCT03032484

Conditions

  • Astrocytoma

Interventions

DrugSynonymsArms
BevacizumabAvastinBevacizumab and TVB-2640
TVB-2640Bevacizumab and TVB-2640

Purpose

Randomized phase 2 study TVB-2640 in combination with Bevacizumab versus Bevacizumab alone.

Detailed Description

      Eligible patients will be randomized into 2 separate arms:

        -  Arm number one will receive Bevacizumab every 2 weeks in combination with TVB-2640 from
           day 1 until day 28 of the first cycle.

        -  Arm number two will receive Bevacizumab alone every 2 weeks, from on days 1 and 15 of
           the first until day 28 of the first cycle.

        -  MR-Spectroscopy will be obtained on all patients (both arms) at day 28 of first cycle.

        -  Starting on cycle 2 day 1, all patients will converge to a single arm and will continue
           to receive bevacizumab every 2 weeks in combination with TVB-2640. Every cycle will last
           28 days.
    

Trial Arms

NameTypeDescriptionInterventions
Bevacizumab and TVB-2640ExperimentalBevacizumab every 2 weeks in combination with TVB-2640 dosed at 100mg/m2 daily (rounded to 50mg tab dose), from day 1 until day 28 of the first cycle.
  • Bevacizumab
  • TVB-2640
BevacizumabExperimentalBevacizumab alone every 2 weeks, on days 1 and 15 until day 28 of the first cycle.
  • Bevacizumab

Eligibility 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 high-grade astrocytoma

          -  Progression following standard combined modality treatment with radiation and
             temozolomide chemotherapy

          -  Recovered from reversible toxicities of prior therapy to Grade 0 or Grade 1

          -  ECOG Pperformance Status of 0 to 2

          -  Life expectancy of at least 3 months

          -  Adequate renal and liver function: AST/ALT ≤ 3 x ULN, Bilirubin ≤ 1.5 times ULN,
             Creatinine ≤ ULN

          -  Adequate hematologic status (without hematologic support): Hemoglobin ≥ 9 g/dL, ANC ≥
             1500 cells/ml, Platelets ≥ 100,000 cells/ml

          -  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 (for example,
             surgical sterilization or the use of 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 six months after the last dose.

        Exclusion Criteria:

          -  Receiving warfarin (or other coumarin derivatives) and is unable to switch to low
             molecular weight heparin (LMWH) before the first dose of study drug

          -  Evidence of acute intracranial or intratumoral hemorrhage either by MRI or CT scan.
             Subjects with resolving hemorrhage changes punctuate hemorrhage, or hemosiderine are
             eligible

          -  Unable to undergo MRI scan (e.g., pacemaker)

          -  Received enzyme-inducing anti-epileptic agents within 14 days of study drug (e.g.,
             carbamazepine, phenytoin, phenobarbital, primidone)

          -  Not recovered to a NCI CTCAE v.4.03 Grade ≤ 1 from AEs (except alopecia and
             lymphopenia) due to surgery, antineoplastic agents, investigational drugs, or other
             medications that were administered prior to study drug

          -  Evidence of wound dehiscence

          -  Pregnant or breast-feeding

          -  Clinically significant Dry Eye or necessary contact lens use

          -  Serious intercurrent illness such as: Hypertension (two or more blood pressure
             readings performed at screening of > 150 mmHg systolic or > 100 mmHg diastolic)
             despite optimal treatment, Non-healing wound or ulcer, Uncontrolled life threatening
             cardiac arrhythmias, Untreated hypothyroidism, Uncontrolled active infection,
             Symptomatic congestive heart failure or unstable angina pectoris within 3 months prior
             to study drug, Gastrointestinal perforation, abdominal fistula, intra-abdominal
             abscess within 1 year

          -  Inherited bleeding diathesis or coagulopathy with the risk of bleeding

          -  HIV , Hepatitis B or C documented infections

          -  Received any of the following prior anticancer therapy: Non-standard radiation therapy
             such as brachytherapy, systemic radioisotope therapy (RIT), or intra-operative
             radiotherapy (IORT). Note: stereotactic radiosurgery (SRS) is allowed,
             Non-antiangiogenic therapy (including investigational agents and small molecular
             kinase inhibitors) within 7 days or 5 half-lives, whichever is shorter, prior to the
             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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Tumor response per RANO (Response Assessment in Neuro-Oncology) criteria
Time Frame:Measured every 8 weeks for 28 day cycles for the duration of study treatment, estimated to be less than one year
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Incidence, nature and severity of adverse events and serious adverse events, graded according to NCI - Common Toxicity Criteria for Adverse Events version (4.03)
Time Frame:1.5 years
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The University of Texas Health Science Center at San Antonio

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