An Open Label, Phase 2 Study Evaluating the Safety and Efficacy of IMC-3G3 or IMC-1121B in Patients With Recurrent Glioblastoma Multiforme
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 80
- Locations
- 22
- Primary Endpoint
- Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6)
Study Overview
Brief Summary
RATIONALE: Monoclonal antibodies, such as ramucirumab and anti-PDGFR alpha monoclonal antibody IMC-3G3 (Olaratumab), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.
PURPOSE: This phase II trial is studying how well ramucirumab or anti-PDGFR alpha monoclonal antibody IMC-3G3 works in treating patients with recurrent glioblastoma multiforme.
Detailed Description
OBJECTIVES:
Primary
- To assess the progression-free survival rate at 6 months after treatment with ramucirumab or anti-PDGFR alpha monoclonal antibody IMC-3G3 in patients with recurrent glioblastoma multiforme.
Secondary
- To evaluate the acute and late toxicities associated with these regimens.
- To assess the objective tumor response rate.
- To estimate the overall survival of these patients.
- To describe the pharmacokinetic and pharmacodynamic profiles and immunogenicity of these regimens.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Group 2
Patients receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Intervention: olaratumab (Biological)
Group 1
Patients receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
Intervention: ramucirumab (Biological)
Outcomes
Primary Outcomes
Percentage of Participants Who Achieved Progression-Free Survival Rate at 6 Months (PFS-6)
Time Frame: Start of treatment to PD or Death Up To 6 Months
PFS was defined as the start of treatment to the earliest date of tumor progression or death from any cause based on the modified Response Assessment in Neuro-Oncology Group through the American Society of Clinical Oncology (RANO) criteria. Progression is defined by any of the following: ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions; any new lesion; or clinical deterioration. RANO is a standardized response criteria using bi-dimensional measurements of the largest contrast-enhancing area (Macdonald, 1990).
Secondary Outcomes
- Number of Participants With Treatment Emergent Adverse Events as Assessed by NCI CTCAE v4.0 (National Cancer Institute-Common Terminology Criteria for Adverse Events)(Start of Treatment to End of Study (Up to 13 Months))
- Percentage of Participants With Anti-Olaratumab Antibodies (ADA)(Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months))
- Median Overall Survival (OS)(Start of Treatment to Death Up To 27 Months)
- Percentage of Participants With Anti-Ramucirumab Antibodies (ADA)(Start of Treatment to 30-day Post Infusion Follow Up (Up to 6 Months))
- Pharmacokinetics (PK): Concentration Maximum (Cmax) and Concentration Minimum (Cmin) of Ramucirumab(Cycle 7, Day 1: Prior to Infusion,1 hour (hr) Post Infusion)
- Percentage of Participants (Pts) With Complete Response (CR), Partial Response (PR) and Minor Response (MR) (Objective Response Rate [ORR])(Start of Treatment to PD Up To 20 Months)
- Pharmacodynamics (PD) Profiles(Cycle 7, Day 1: Prior to Infusion, 1 hr Post Infusion)
- PK: Cmax and Cmin of Olaratumab(Cycle 3, Day 1: Prior to Infusion, 1 hr Post Infusion)