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NCT01333475 · ClinicalTrials.gov registry record · Phase 2
MK-2206 and AZD6244 in Patients With Advanced Colorectal Carcinoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT01333475: Completed Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT01333475 is a Phase 2 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01333475, a Phase 2 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
Background: \- MK-2206 and AZD6244 (Selumetinib) are experimental cancer treatment drugs that block the effect of certain proteins that cancer cells need to grow and survive. These drugs may be effective treatments for some types of colorectal cancer that has not responded to or has relapsed after standard treatment. Researchers are interested in studying how MK-2206 and AZD6244 affect levels of certain proteins in colorectal cancer tumor, and how well the drugs work against cancer cells by examining cells from a tumor sample collected before the drugs are given and again after the drugs are given. Objectives: \- To evaluate the safety and effectiveness of MK-2206 and AZD6244 in individuals with advanced colorectal carcinoma that has not responded to standard treatments. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with advanced colorectal carcinoma that has not responded to at least one type of standard chemotherapy. Design: * Participants will be screened with a physical examination, medical history, blood tests, and tumor imaging studies. * Participants will take MK-2206 and AZD6244 by mouth for 4-week cycles of treatment, with one dose of MK-2206 per week and one dose of AZD6244 every day. (If participants have negative side effects from the medications, the doses will be adjusted to a smaller dose). Participants will keep a diary to record doses and keep track of any side effects. * During treatment, participants will have regular visits to the clinical center, involving blood and urine tests, tumor biopsies, and other examinations to monitor the effects of treatment. Participants will have imaging studies every two cycles (8 weeks) to study the cancer's response to the treatment. * Participants will continue to have cycles of treatment for as long as the treatment continues to be effective and the side effects are not severe enough to stop participation in the study....
Primary Outcome
A predetermined target inhibition reduction of 70% of both pERK and pAKT was deemed significant, thus tumor biopsies were performed at C1D1 or C1D22 post administration and evaluated using quantitative chemiluminescence immunoassay to measure pERK and pAKT levels in human tissue.
Interventions
- DRUG MK-2206 + AZD6244
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01333475 record still lists
NCT01333475 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 1 intervention - of which MK-2206 + AZD6244 is the first listed.
NCT01333475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01333475 about?
NCT01333475 is a clinical study titled "MK-2206 and AZD6244 in Patients With Advanced Colorectal Carcinoma". Background: \- MK-2206 and AZD6244 (Selumetinib) are experimental cancer treatment drugs that block the effect of certain proteins that cancer cells need to grow and survive. These drugs may be effective treatments for some types of colorectal cancer that has not responded to or has relapsed after ...
What is the current status of trial NCT01333475?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2011-03. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01333475?
The interventions under investigation include: MK-2206 + AZD6244 (DRUG).
Who is sponsoring clinical trial NCT01333475?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01333475's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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