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Angiogenesis Inhibitor
1 for Brain Tumor
Phase 2
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
DISEASE CHARACTERISTICS
Histologically confirmed diagnosis of recurrent/progressive GBM presenting in first, second, or third relapse (progression following anti-cancer therapy other than surgery)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part 1: cycle 1, days 1-3, day 5 or 6, days 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; eos and follow up visits. part 2: cycle 1, days 1, 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; eos and follow up visits.
Awards & highlights
Study Summary
RATIONALE: CT-322 may stop the growth of glioblastoma multiforme by blocking blood flow to the tumor. Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving CT-322 together with irinotecan may kill more tumor cells. PURPOSE: This phase 2 trial is studying the side effects, tolerability, and efficacy of CT-322 when given alone and in combination with irinotecan to patients with glioblastoma multiforme.
Eligible Conditions
- Brain Tumor
- Glioblastoma
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ part 1: cycle 1, days 1-3, day 5 or 6, days 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; eos and follow up visits. part 2: cycle 1, days 1, 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; eos and follow up visits.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part 1: cycle 1, days 1-3, day 5 or 6, days 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; eos and follow up visits. part 2: cycle 1, days 1, 8, 15, and 22; cycles 2-4, 6, 9, and 12, day 1; eos and follow up visits.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Progression-free survival at 6 months (Part 2)
Safety and tolerability of CT-322 when administered alone or in combination with irinotecan hydrochloride (Part 1)
Secondary outcome measures
To assess the biological activity of CT-322 as measured by plasma biological markers and neuroimaging
To assess the plasma pharmacokinetics of CT-322 (Cmax, Tmax, AUC, T-HALF) derived from plasma concentration vs time for CT-322 given alone and in combination with irinotecan
To assess the presence of anti CT-322 antibodies
Trial Design
2Treatment groups
Experimental Treatment
Group I: 2Experimental Treatment2 Interventions
CT-322 and irinotecan hydrochloride
Group II: 1Experimental Treatment1 Intervention
CT-322
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pegdinetanib
Not yet FDA approved
Irinotecan
FDA approved
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Who is running the clinical trial?
Adnexus, A Bristol-Myers Squibb R&D CompanyLead Sponsor
2 Previous Clinical Trials
70 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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