Study of Tivantinib (ARQ 197) Plus Cetuximab in EGFR Inhibitor-Resistant MET High Subjects
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|ClinicalTrials.gov Identifier: NCT01892527|
Recruitment Status : Unknown
Verified February 2016 by Armando Santoro, MD, Istituto Clinico Humanitas.
Recruitment status was: Active, not recruiting
First Posted : July 4, 2013
Last Update Posted : February 17, 2016
This is a single-arm, Simon 2-stage, phase 2 clinical study conducted in subjects with advanced or metastatic colorectal cancer who have previously received ≥ 1 prior line of systemic therapies and are resistant to EGFR inhibitor (cetuximab or panitumumab).
This trial will be conducted to determine objective response rate (ORR), progression-free survival (PFS) and overall-survival (OS) of cetuximab plus tivantinib in patients with wild-type KRAS CRC that is resistant to anti-EGFR antibody treatment (cetuximab or panitumumab) and shows overexpression of cMET.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Metastatic C-met Overexpression||Drug: Tivantinib (ARQ197)||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single-Arm Phase II Study of Tivantinib (ARQ 197) Plus Cetuximab in EGFR Inhibitor-Resistant MET High Subjects With Locally Advanced or Metastatic Colorectal Cancer With Wild-Type KRAS|
|Study Start Date :||March 2013|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||March 2017|
Experimental: Tivantinib plus Cetuximab
Drug: Tivantinib (ARQ197)
Eligible subjects will be treated with tivantinib (ARQ 197) at a dose of 360 mg twice daily (a total daily dose of 720 mg) orally in a continuous manner and cetuximab (Erbitux) at a dose of 500 mg/mq i.v. every 2 weeks.
Other Name: Cetuximab
- Study of Tivantinib (ARQ 197) plus Cetuximab in EGFR inhibitor-Resistant MET High Subjects with Locally Advanced or Metastatic Colorectal Cancer with Wild-Type KRAS [ Time Frame: 36 months ]To determine objective response rate (ORR).
- Tivantinib (ARQ 197) plus Cetuximab in EGFR inhibitor-Resistant MET High Subjects [ Time Frame: 36months ]To estimate progression-free survival (PFS).
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): NCT01892527
|Istituto Clinico Humanitas|
|Rozzano, Milano, Italy, 20089|
|Study Chair:||Lorenza Rimassa, MD||Istituto Clinico Humanitas|