Glioblastoma Clinical Trial
Official title:
Open-label, Single Arm, Safety and Tolerability Dose Escalation Study of VAL-083 in Patients With Recurrent Malignant Glioma
Verified date | January 2017 |
Source | DelMar Pharmaceuticals, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this Phase 1/2, open-label, single-arm study is to determine the safety and the maximal tolerated dose (MTD) of VAL-083 in patients with recurrent malignant glioma. Pharmacokinetic (PK) properties will be explored and tumor responses to treatment will be evaluated.
Status | Completed |
Enrollment | 55 |
Est. completion date | October 2016 |
Est. primary completion date | December 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must be greater than or equal to 18 years old. - Histologically confirmed initial diagnosis of primary WHO Grade IV malignant glioma (glioblastoma), now recurrent; or Cohorts 2 and 3 only: progressive secondary brain tumor, has failed standard brain radiotherapy, and has brain tumor progression after at least one line of systemic therapy. Patients with progressive secondary brain tumors will not be enrolled under this protocol following the completion of Cohort 3. - If GBM, previously treated for GBM with surgery and/or radiation, if appropriate, and must have failed both bevacizumab (Avastin) and temozolomide (Temodar), unless either or both are contraindicated. - If GBM, greater than or equal to 12 weeks from radiotherapy, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field. - Cohorts 2 & 3 only: Patients with secondary brain tumors must be greater than or equal to 4 weeks from radiotherapy. Patients with progressive secondary brain tumors will not be enrolled under this protocol following the completion of Cohort 3. - At least 4 weeks from last chemotherapy or bevacizumab (Avastin) therapy (6 weeks for nitrosourea or mitomycin C), or for chemotherapy regimes given continuously or on a weekly basis with limited potential for delayed toxicity, at least 2 weeks from last dose. - At least 21 days or 5 half-lives (whichever is shorter) since prior investigational anti-cancer drugs. A minimum of 10 days between termination of the investigational drug and administration of DAG is required - Recovered from all treatment-related toxicities to Grade 1 or less. - Must have a Karnofsky performance status of > 50 with a predicted life expectancy of at least 12 weeks. - Must have known MGMT methylation and IDH1 mutation status to be screened for study entry. Exclusion Criteria: - Current history of neoplasm other than the entry diagnosis. Patients with previous cancers treated and cured with local therapy alone may be considered with approval of the Medical Monitor. - Evidence of leptomeningeal spread of disease. - Evidence of recent hemorrhage on baseline MRI of the brain. - Concurrent severe, intercurrent illness. - History of severe cardiac disease. - Significant vascular disease. - History of stroke or transient ischemic attack within 6 months prior to beginning treatment. - Concomitant medications that are known inducers of CYP. - Concomitant medications that are strong inhibitors of cytochrome P450 and CYP3A up to 14 days before Cycle 1 Day 1 (pimozide, diltiazem, erythromycin, clarithromycin, and quinidine, and amiodarone up to 90 days before) - Known to be HIV positive or to have an AIDS-related illness. - Pregnant or breast feeding. |
Country | Name | City | State |
---|---|---|---|
United States | Sarah Cannon Research Institute | Denver | Colorado |
United States | Sarah Cannon Research Institute | Nashville | Tennessee |
United States | Mayo Clinic | Rochester | Minnesota |
United States | University of California, San Francisco, Division of Neuro-Oncology | San Francisco | California |
United States | Florida Cancer Specialists | Sarasota | Florida |
Lead Sponsor | Collaborator |
---|---|
DelMar Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of maximum tolerated dose (MTD) | The determination of MTD will be based on analysis of tolerance data from the first cycle of therapy in each dose group. | Study Day 35 | |
Secondary | Evaluate tumor response in patients with recurrent malignant glioma | Tumor assessment every other treatment cycle, as long as patient continues to demonstrate response or stable disease and tolerates therapy. | Every 60 days | |
Secondary | Characterization of Cycle 1 plasma pharmacokinetics | Plasma will be analyzed to estimate appropriate PK parameters (Cmax, Tmax, AUC, elimination half-life, drug clearance, mean residence time, and volume of distribution). | Cycle 1: 0, 0.25, 0.5, 1, 2, 4, 6 hrs and immediately prior to Cycle 1, Day 2 dosing |
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