| General information |
| Database: | DB00587 |
| Objective: | This study evaluated CT322 in an openlabel runin/phase 2 setting to assess its efficacy and safety in recurrent glioblastoma. Eligible patients had 1st, 2nd or 3rd recurrence of glioblastoma with measurable tumor on MRI and no prior antiangiogenic therapy. |
| Authors: | Schiff D, et al |
| Title: | Phase 2 study of CT322, a targeted biologic inhibitor of VEGFR2 based on a domain of human fibronectin, in recurrent glioblastoma. |
| Journal: | Invest New Drugs. |
| Year: | 2015 |
| PMID: | 25388940 |
| Trial Design |
| Clinical Trial Id: | NA |
| Agent: | CT322
|
| Target: | Vascular endothelial growth factor receptor 2
|
| Cancer Type: | Tumors of the nervous system |
| Cancer Subtype: | glioblastoma |
| Therapy Type: | mono |
| Therapeutic Combination Type: | NA |
| Therapeutic Combination Content: | NA |
| Study Type: | a phase II, twopart, openlabel study |
| Key Patients Feature: | Eligible patients were at least 18 years of age with a histologically confirmed diagnosis of a recurrent/progressive GBMand presenting in first, second, or third relapse. Patients had tohave evidence of bidimensionally measurable recurrent or residual tumor on contrastenhanced magnetic resonance imaging (MRI) and the ability to undergo serial contrastenhanced MRevaluations. Karnofsky performance status (KPS) more than and equal to 70 % andadequate bone marrow, liver, and renal function were requisite. |
| Biomarker: | NA |
| Biomark Analysis: | NA |
| Control Group Info: | single arm |
| Treatment Info: | The initial CT322 dose was 1 mg/kg IV weekly, with plans to escalate subsequent patients to 2 mg/kg weekly if tolerated; within each CT322 dose cohort, patients were randomized to ¡Àirinotecan IV semiweekly |
| Primary End Point: | 6month progression free survival (PFS6) |
| Secondary End Point: | NA |
| Patients Number: | 63 |
| Trial Results |
| DLT_MTD: | The initial CT322 dose was 1 mg/kg IV weekly, with plans to escalate subsequent patients to 2 mg/kg weekly if tolerated; within each CT322 dose cohort, patients were randomized to ¡Àirinotecan IV semiweekly. |
| Objective Response Rate: | NA |
| Disease Control Rate: | NA |
| Median Time to Progression: | NA |
| Median PFS A vs. C: | The PFS6 rate in the CT322 monotherapy groups was 18.6 and 0.0 % in the 1 and 2 mg/kg treatment groups, respectively |
| Median OS A vs. C: | NA |
| Adverse Event(agent arm): | Onethird experienced serious adverse events, of which four were at least possibly related to study treatment (two intracranial hemorrhages and two infusion reactions). Twentynine percent of subjects developed treatmentemergent hypertension. |
| Conclusions: | The study was terminated prior to reaching the planned enrollment for all treatment groups because data from the completed CT322 2 mgkg monotherapy treatment arm revealed insufficient efficacy. Despite biological activity and a tolerable side effect profile, CT322 failed to meet the prespecified threshold for efficacy in recurrent glioblastoma. |