Safety & Efficacy Study of TPI 287 + Avastin in Adults With Glioblastoma That Progressed Following Prior Avastin Therapy

Stopped early · Phase 2

Conditions studied: Glioblastoma Multiforme

In brief

The purpose of this study is to evaluate the safety, maximum tolerated dose (MTD), and efficacy of TPI 287 in combination with Avastin (bevacizumab) in subjects who have glioblastoma multiforme (GBM) that has progressed following prior radiation and temozolomide (TMZ) therapy and that has progressed following prior bevacizumab therapy.

Key facts

Study ID

NCT02047214

Run by

Cortice Biosciences, Inc.

People needed

17

Starts

2014-01-01

Expected to finish

2015-12-01

Last updated by the study team

2018-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven GBM
• Disease progression following radiation \& TMZ
• 1st progression of GBM on bevacizumab-containing regimen or within 8 weeks of discontinuing bevacizumab. In either case, must have received a minimum of 8 weeks (4 infusions) of bevacizumab.
• Baseline MRI must be performed after subject signs informed consent form (ICF), within 17 days of Day 1, \& on steroid dosage that has been stable or decreasing for at least 5 days
• Recent resection of recurrent or progressive tumor allowed as long as at least 4 weeks have elapsed from date of surgery \& subject has recovered from surgery
• Life expectancy >12 weeks
• Eighteen years old or older
• KPS equal to or greater than 70
• Recovered from toxic effects of prior therapy to < Grade 2 toxicity per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) prior to Day 1. Minimum duration required between prior therapy \& Day 1 is:
• At least 12 weeks from completion of radiation therapy except if there is unequivocal evidence for tumor recurrence in which case at least 4 weeks
• 4 weeks from prior cytotoxic therapy
• 4 weeks from prior experimental drug
• 6 weeks from nitrosoureas
• 3 weeks from procarbazine
• 1 week for non-cytotoxic agents (e.g., interferon, tamoxifen, \& cis-retinoic acid)
• 14 days from last dose of bevacizumab
• Adequate bone marrow function [absolute neutrophil count (ANC) > 1,500/mm3 \& platelet count of > 100,000/mm3], adequate liver function [alanine aminotransferase (ALT) \& aspartate aminotransferase (AST) <3 x upper limit normal (ULN), alkaline phosphatase <2 x ULN, \& total bilirubin <1.5 mg/dL], \& adequate renal function (BUN \& creatinine <1.5 x ULN)
• Minimum hemoglobin of 9 g/dL
• Males \& women of childbearing potential must agree to abstain from sex or use an adequate method of contraception for duration of study \& for 6 months after last dose of study drug
• Signed \& dated ICF prior to Screening evaluations

You may not qualify if…

• Radiographic evidence of contrast-enhancing tumor crossing midline, leptomeningeal dissemination, gliomatosis cerebri or infratentorial tumor
• Evidence or suspicion of disease metastatic to sites remote from supratentorial brain
• Prior treatment with anti-vascular endothelial growth factor (VEGF) drugs other than bevacizumab
• Prior treatment with tyrosine-kinase inhibitors targeting VEGF, platelet-derived growth factor, fibroblast growth factor, tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2 (TIE-2), or angiopoietin (or their receptors)
• Prior treatment with histone deacetylase inhibitors or mammalian target of rapamycin (mTOR) inhibitors
• Prior treatment with TPI 287
• Treatment with Enzyme-Inducing Anti-Epileptic Drugs within 2 weeks prior to Day 1
• Treatment with drugs or herbal supplements known to be strong inhibitors/inducers of cytochrome P450 3A4 or 2C8 within 2 weeks prior to Day 1
• Received more than one course of radiation therapy or more than a total dose of 65 Gy. May have received radiosurgery as part of initial therapy; however, dose counts against total dose limit.
• Prior taxane, vincristine, or other microtubule inhibitor chemotherapies for treatment of GBM or other malignancy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 1 or anticipation of need for major surgical procedure during course of study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to Day 1
• Any condition, including the presence of clinically significant laboratory abnormalities, which places subject at unacceptable risk if he/she were to participate in study or confounds the ability to interpret data from study, including:
• Active infection including known AIDS or Hepatitis C or with a fever ≥38.5°C within 3 days prior to study enrollment
• Diseases or conditions that obscure toxicity or dangerously alter drug metabolism
• Serious intercurrent medical illness (e.g., symptomatic congestive heart failure)
• Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent subject from providing informed consent
• Inadequately controlled hypertension (defined as systolic blood pressure >140 mmHg and/or diastolic blood pressure > 90 mmHg)
• Prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association Grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 6 months prior to Day 1
• History of stroke or transient ischemic attack within 6 months prior to Day 1
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or recent peripheral arterial thrombosis) within 6 months prior to Day 1
• History of hemoptysis (≥ 1/2 teaspoon of bright red blood per episode) within 1 month prior to Day 1
• Evidence of bleeding diathesis or significant coagulopathy (in absence of therapeutic anticoagulation)

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• H Lee Moffitt Cancer Center and Research Institute, Inc. — Tampa, Florida, United States
• Northwestern Medical Faculty Foundation — Chicago, Illinois, United States
• Washington University, School of Medicine — St Louis, Missouri, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• John Theurer Cancer Center at Hackensack University Medical Center — Hackensack, New Jersey, United States
• University of Rochester Medical Center — Rochester, New York, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Memorial Hermann Hospital — Houston, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Swedish Neuroscience Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.