Cabozantinib and Panitumumab to Treat KRAS Wild-Type Metastatic Colorectal Cancer

Part of paid clinical trials in Durham, North Carolina.

Sponsor
John Strickler, M.D.
Study ID
NCT02008383
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Panitumumab — BIOLOGICAL
    The FDA approved dose for panitumumab is 6mg/kg IV, every two weeks. This is the dose and schedule that will be used in this study.
  • Cabozantinib — DRUG
    There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2) the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. Cabozantinib will start at a dose of 60 mg daily with reductions to 40 and 20 mg daily possible in the dose finding cohort. The combination expansion cohort dose will determined by the dose finding cohort. The Monotherapy MET Amplified cohort will recieve 60 mg Cabozantinib daily.

Study Details

There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2) the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort. In the Combination Dose Finding cohort and the Combination Expansion cohort, we will combine cabozantinib and panitumumab in patients with KRAS wild-type metastatic colorectal cancer (CRC). In the Monotherapy MET Amplified cohort, we will screen at least 50 patients for MET gene amplification ("MET amplification"). Patients with MET amplification will receive cabozantinib only (monotherapy). The primary objective of this open-label phase Ib trial are: 1. To determine the maximum tolerated dose and the recommended phase II dose for the combination of cabozantinib and panitumumab in patients with KRAS wild-type metastatic colorectal cancer and 2. To identify the objective response rate (ORR) of cabozantinib monotherapy in patients with prospectively identified MET amplified metastatic colorectal cancer. The secondary objectives are: 1. To describe the non-dose limiting toxicities of cabozantinib and panitumumab. 2. To describe the clinical activity (ORR, PFS, OS) of cabozantinib and panitumumab. 3. To describe the safety and tolerability of cabozantinib monotherapy in patients with MET amplified colorectal cancer. 4. To describe the clinical activity (PFS, OS) of cabozantinib monotherapy in patients with MET amplified colorectal cancer.

Key Dates

Start date
Jan 31, 2014
Status verified
Feb 2021
Primary completion
May 10, 2018
Completion
Aug 29, 2018

Study Design

Enrollment
29 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cabozantinib and Panitumumab
    60 mg Cabozantinib PO daily and 6 mg/kg Panitumumab IV every 2 weeks.
  • Experimental: Cabozantinib
    60 mg Cabozantinib PO daily.

Primary Outcome Measure

Recommended phase II dose (RPTD) for the combination of cabozantinib and panitumumab [ Time Frame: RPTD for the study will be determined at the completion of Phase I dose escalation cohort; estimated as 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer Center, Duke University Medical CenterDurhamNorth Carolina27710-

Find similar trials in Durham, NC

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Duke Cancer Center, Duke University Medical Center· Durham, NC

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