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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Cortice Biosciences, Inc.
Study ID
NCT02047214
Phase
PHASE2
Status
Terminated

Conditions

  • Glioblastoma Multiforme

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TPI 287 — DRUG
    TPI 287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class. TPI 287 is an Investigational Drug.
  • Bevacizumab — DRUG
    Avastin (bevacizumab) is an FDA approved drug indicated for multiple cancers, including as a single agent for GBM for adult patients with progressive disease following prior therapy. Single agent effectiveness is based on improvement in objective response rate; no data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab.

Study Details

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 Dates

First listed
Jan 28, 2014
Start date
Jan 31, 2014
Status verified
Jan 2018
Primary completion
Dec 31, 2015
Completion
Dec 31, 2015

Study Design

Enrollment
17 participants (actual)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: TPI 287 + bevacizumab
    All subjects will be administered TPI 287 as an IV infusion (1-hour target duration) once every 3 weeks (Days 1 and 22) and bevacizumab as a 30 to 90 minute IV infusion once every 2 weeks (Days 1, 15, and 29) of a 42-day cycle. The dose of TPI 287 will be escalated in sequential dose cohorts of 3 to 6 subjects, while the dose of bevacizumab remains constant (10 mg/kg). The planned dose escalation levels are 140, 160, 170, and 180 mg/m2; subsequent dose levels will be increased in increments of 10 mg/m2. If dose de-escalation below the starting dose level of 140 mg/m2 is required, dose levels of 130 and 120 mg/m2 will be used. Once the MTD is identified, 6 additional subjects will be enrolled at the MTD to better characterize the toxicity profile at this level. Subjects may continue on treatment unless they meet one or more of the discontinuation criteria outlined in the protocol.

Primary Outcome Measure

Safety of TPI 287 + bevacizumab in adults with GBM that progressed following radiation & TMZ & prior bevacizumab as measured by AEs, physical/neurologic exam, KPS, weight, vital signs, hematology, serum chemistry, & urinalysis [ Time Frame: Continuously over study treatment through 4 weeks after last dose of study drug ]

Locations (11)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35249-
H Lee Moffitt Cancer Center and Research Institute, Inc.TampaFlorida33612-
Northwestern Medical Faculty FoundationChicagoIllinois60611-
Washington University, School of MedicineSt LouisMissouri63110-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601-
University of Rochester Medical CenterRochesterNew York14642-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Memorial Hermann HospitalHoustonTexas77030-
University of Virginia Health SystemCharlottesvilleVirginia22908-
Swedish Neuroscience InstituteSeattleWashington98122-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALH Lee Moffitt Cancer Center and Research Institute, Inc.· Tampa, FLNorthwestern Medical Faculty Foundation· Chicago, ILWashington University, School of Medicine· St Louis, MODartmouth-Hitchcock Medical Center· Lebanon, NHJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJ

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