NCT01287130

AZD6244 With Cetuximab for Solid Tumors and Colorectal Cancer

Completed Phase 1 Last updated 17 December 2019

What this trial tests

Phase 1 trial testing Cetuximab in Colonic Neoplasms in 10 participants. Completed in 27 August 2013.

Timeline

7 January 2011

Primary endpoint
27 August 2013

27 August 2013

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	7 January 2011
Primary completion	27 August 2013
Estimated completion	27 August 2013
Sites	1 location across United States

Drugs / interventions tested

• Cetuximab (cetuximab) — full drug profile →
• AZD6244 — full drug profile →

Conditions studied

• Colonic Neoplasms — all drugs for Colonic Neoplasms →
• Cancer of the Colon — all drugs for Cancer of the Colon →
• Colon Cancer — all drugs for Colon Cancer →
• Colon Neoplasms — all drugs for Colon Neoplasms →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 99, any sex, with Colonic Neoplasms or Cancer of the Colon. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

\- The experimental cancer treatment drug AZD6244 has been shown to block signals that tell cancer cells to grow. Cetuximab, a drug approved to treat cancer of the head, neck, colon, and rectum, also blocks signals that tell cancer cells to grow. Researchers are investigating the highest safe dose of AZD6244 to give with cetuximab, and will also investigate the effectiveness of this drug combination in individuals who have colorectal cancer that involves a particular protein known as the K-RAS protein. Cetuximab is not used to treat colorectal cancer with K-RAS tumors because it has not been shown to be effective, but researchers believe that adding AZD6244 to cetuximab may improve how well cetuximab works, even in people with K-RAS tumors.

Objectives:

* To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for solid tumors that have not responded to standard treatment.
* To evaluate the safety and effectiveness of AZD6244 in combination with cetuximab for colorectal cancer that involves the K-RAS protein and has not responded to standard treatment.

Eligibility:

* Individuals at least 18 years of age who have been diagnosed with solid tumors that have not responded to standard treatment.
* Individuals at least 18 years of age who have been diagnosed with colorectal cancer that has not responded to standard treatment.

Design:

* This protocol will involve two separate studies: an initial study to establish the highest safe and effective dose of AZD6244 and cetuximab in individuals with solid tumors, and an expansion study of AZD6244 and cetuximab in individuals with colorectal cancer involving the K-RAS protein.
* Participants will be screened with a full medical history and physical examination, blood samples, imaging studies, and other tests as required by the researchers.
* AZD6244 is a capsule to be swallowed once or twice a day, every day, with water on an empty stomach. Cetuximab will be given intravenously once a week, over 2 hours for the first dose and over an hour for every following dose. This combination of daily AZD6244 and weekly cetuximab will be repeated in 28-day cycles of treatment. Participants will keep a diary to record the time of taking AZD6244 each day, as well as any side effects.
* Participants will have frequent blood tests and other exams during the first cycle of treatment, up to five visits to the National Institutes of Health (NIH) and other visits to their local doctor to in the first 28-day cycle.
* During subsequent cycles, participants will have four visits to NIH and four visits to your local doctor for examinations, blood tests, and imaging studies.
* Participants may continue to receive the AZD6244 with cetuximab for up to 6 cycles, until the tumor grows, unacceptable side effects development, or the participant or participant's doctor decides to stop participation. There will be a final study visit that repeats the procedures performed during the screening visit....

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Comprehensive review of targeted therapy for colorectal cancer.
   Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z
2. A phase I study of selumetinib (AZD6244/ARRY-142866), a MEK1/2 inhibitor, in combination with cetuximab in refractory solid tumors and KRAS mutant colorectal cancer.
   Deming DA, Cavalcante LL, Lubner SJ, Mulkerin DL, et al · · 2016 · cited 41× · PMID 26666244 · DOI 10.1007/s10637-015-0314-7
3. Clinical Pharmacokinetics and Pharmacodynamics of Selumetinib.
   Campagne O, Yeo KK, Fangusaro J, Stewart CF. · · 2021 · cited 35× · PMID 33354735 · DOI 10.1007/s40262-020-00967-y