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1 for Glioblastoma
Phase 1
Waitlist Available
Research Sponsored by Adnexus, A Bristol-Myers Squibb R&D Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up rt phase treatment weeks 1-3, 5, 7-10, day 1. post rt phase cycles 1-3, day 1; then day 1 every 3 cycles thereafter; eos visit
Awards & highlights
Study Summary
Rationale: In light of the demonstrated activity of anti-angiogenesis agents in rGBM, it is reasonable to postulate that adding these agents to standard RT and chemotherapy in the up-front management of newly diagnosed GBM may improve the clinical benefit. This study will examine the safety and tolerability of adding CT-322 to the standard radiation therapy/temozolomide (RT/TMZ) backbone of treatment for newly diagnosed GBM
Eligible Conditions
- Glioblastoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ rt phase treatment weeks 1-3, 5, 7-10, day 1. post rt phase cycles 1-3, day 1; then day 1 every 3 cycles thereafter; eos visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~rt phase treatment weeks 1-3, 5, 7-10, day 1. post rt phase cycles 1-3, day 1; then day 1 every 3 cycles thereafter; eos visit
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Establish the recommended Phase 2 dose for the QW schedule of CT-322 for use in this combination
Evaluate the safety and tolerability of CT-322 administered in combination with standard focal brain RT/TMZ to subjects with newly diagnosed GBM
Secondary outcome measures
Brain
To describe the PK of TMZ and its active metabolite (MTIC) when TMZ is administered alone and when it is co-administered with CT-322 to a subset of approximately 12 subjects with newly diagnosed GBM
To describe the peak and trough concentrations of CT-322 when administered alone and when co-administered with TMZ
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegdinetanib
Not yet FDA approved
Radiation Therapy
2017
Completed Phase 3
~7250
Temozolomide
FDA approved
Find a Location
Who is running the clinical trial?
Adnexus, A Bristol-Myers Squibb R&D CompanyLead Sponsor
2 Previous Clinical Trials
112 Total Patients Enrolled
1 Trials studying Glioblastoma
72 Patients Enrolled for Glioblastoma
Frequently Asked Questions
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