TH-302 in Combination With Bevacizumab for Glioblastoma

NCT02342379 | Completed Phase 2 Results DMC

• 2 other identifiers: CTRC 12-0105HSC20130212H
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 2

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.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Adverse Events

  Safety lab tests and adverse event assessment

  4 months

Secondary Outcomes (1)

• Progression Free Survival

  4 months

Study Arms (1)

Bevacizumab and TH-302

EXPERIMENTAL

Patients will be treated with combination of bevacizumab and TH-302.

Drug: Bevacizumab; Drug: TH-302

Interventions

Bevacizumab DRUG

10mg/kg

Also known as: Avastin

Bevacizumab and TH-302

TH-302 DRUG

670mg/m2

Also known as: MSC2491899A

Bevacizumab and TH-302

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Bilirubin ≤ 1.5 times upper limit of normal
• 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):
• ANC ≥1500 cells/uL
• Platelet count ≥100,000/uL

You may not qualify if:

• 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:
• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Bevacizumab; TH 302

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Andrew Brenner, MD, PhD
• Organization: University of Texas Health San Antonio

brennera@uthscsa.edu

210-450-5936

Study Officials

• Andrew Brenner, MD

  University of Texas Health Science Center San Antonio at the Cancer Therapy and Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2015
• First Posted: January 19, 2015
• Study Start: May 1, 2015
• Primary Completion: January 4, 2019
• Study Completion: December 4, 2019
• Last Updated: April 10, 2020
• Results First Posted: April 10, 2020

Record last verified: 2020-04

Locations

US (2)