INC280 Combined With Bevacizumab in Patients With Glioblastoma Multiforme
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|ClinicalTrials.gov Identifier: NCT02386826|
Recruitment Status : Active, not recruiting
First Posted : March 12, 2015
Last Update Posted : September 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme Gliosarcoma Colorectal Cancer Renal Cell Carcinoma||Drug: INC280 Biological: bevacizumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase Ib Study Evaluating the c-Met Inhibitor INC280 in Combination With Bevacizumab in Patients With Glioblastoma Multiforme (GBM)|
|Actual Study Start Date :||September 22, 2015|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: INC280 + Bevacizumab
Cohort A: 20 GBM patients - progressed during or after standard 1st-line therapy; Cohort B: 15 GBM patients - progressed during or after 2nd-line bevacizumab therapy; Cohort C: 10 unresectable GBM patients.
INC280: PO twice daily at the MTD. Bevacizumab: 10 mg/kg IV once every 2 weeks for Cohorts A and B; 15 mg/kg IV every 4 weeks for Cohort C Treatment cycles will be repeated every 28 days (4 weeks).
Dose Escalation: INC280 by mouth (PO) twice daily for 28 days according to the following schedule until the maximum tolerated dose (MTD) is determined:
Dose Level 1 (starting dose): 200 mg (divided dose of 100 mg twice per day) Dose Level 2: 400 mg (divided dose of 200 mg twice per day) Dose Level 3: 800 mg (divided dose of 400 mg twice per day)
Dose Expansion: INC280 PO twice daily at the MTD determined in the dose escalation phase
Other Name: INCB28060
bevacizumab: 10 mg/kg IV every 2 weeks. Patients with unresectable GBM will be given 15 mg/kg IV every 4 weeks.
Other Name: Avastin
- Maximum Tolerated Dose (MTD) of INC280 [ Time Frame: weekly for 4 weeks ]The MTD of INC280 to be administered with standard dose bevacizumab is determined as the highest dose at which ≤1 of 6 patients experiences a dose limiting toxicity (DLT) during one cycle (28 days) of therapy, assessed by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v. 4.0.3
- Progression-free Survival [ Time Frame: every 8 weeks until treatment discontinuation, expected average of 6 months ]Progression-free survival is measured from Day 1 of study drug administration to disease progression or death on study. Disease progression is assessed by Response Assessment in Neuro-Oncology (RANO) criteria.
- Overall Response Rate [ Time Frame: Every 8 weeks up to 6 months ]Defined as the proportion of patients with confirmed complete response or partial response (CR or PR) assessed according to RANO criteria. CR=complete disappearance of all measurable and non-measurable disease sustained for at least 4 weeks. PR=≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02386826
|United States, Colorado|
|Sarah Cannon Research Institute at HealthONE|
|Denver, Colorado, United States, 80218|
|United States, Connecticut|
|Yale School of Medicine|
|New Haven, Connecticut, United States, 06520|
|United States, Missouri|
|HCA Midwest - Kansas City|
|Kansas City, Missouri, United States, 64132|
|United States, Oklahoma|
|Oklahoma University Health Science Center|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Tennessee|
|Tennessee Oncology PLLC|
|Nashville, Tennessee, United States, 37203|
|Study Chair:||Kent C. Shih, M.D.||SCRI Development Innovations, LLC|