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NCT01134601 · ClinicalTrials.gov registry record · Phase 1
A Phase I Study of AZD6244 in Combination With Capecitabine and Radiotherapy in Locally Advanced Adenocarcinoma of the Rectum
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 1
- Development phase
- 1
- Enrollment target
NCT01134601: Clinical Trial Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01134601 is a Phase 1 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 1 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01134601, a Phase 1 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 1 participants
- Enrollment target
Study Summary
Background: \- The investigational anti-cancer drug Selumetinib (AZD6244) prevents a protein found in rectal cancer from working properly, which may slow tumor growth and allow radiation and chemotherapy treatments to destroy more cancer cells. Researchers are interested in determining whether AZD6244 can be used to improve treatment outcomes in individuals who have rectal cancer that has spread outside the rectum into the surrounding pelvis. Objectives: \- To determine safe and effective doses of AZD6244, along with radiation and chemotherapy, to treat rectal cancer. Eligibility: \- Individuals at least 18 years of age who have been diagnosed with rectal cancer that has spread outside the inner wall of the rectum or into lymph nodes in the pelvis. Design: * Eligible participants will be screened with a physical examination, blood and tumor samples, and imaging studies. * Participants will receive AZD6244 twice a day by mouth for 1 full week (7 days) before starting radiation and chemotherapy and every week thereafter until the end of the radiation and chemotherapy treatment. * Participants will have radiation therapy daily, 5 days per week, for approximately 6 weeks. * Participants will receive chemotherapy (capecitabine) twice daily, 5 days per week, for approximately 6 weeks. * Approximately 4 to 8 weeks after completing the AZD6244, radiation, and chemotherapy treatment, participants may have surgery to remove any tumors and affected lymph nodes. This surgery is not part of the treatment delivered on this protocol. * Participants will have a follow-up exam 3 weeks after the end of treatment, every 3 months for the first year, and then in the second and third year after the end of treatment. These visits will involve a full medical examination and imaging studies.
Interventions
- DRUG Capecitabine
- PROCEDURE Radiation Therapy
- DRUG AZD6244
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2010-05-24 |
| Est. Completion | 2012-10-22 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01134601
The ClinicalTrials.gov registry entry for NCT01134601 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Capecitabine is the first listed.
NCT01134601 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01134601 about?
NCT01134601 is a clinical study titled "A Phase I Study of AZD6244 in Combination With Capecitabine and Radiotherapy in Locally Advanced Adenocarcinoma of the Rectum". Background: \- The investigational anti-cancer drug Selumetinib (AZD6244) prevents a protein found in rectal cancer from working properly, which may slow tumor growth and allow radiation and chemotherapy treatments to destroy more cancer cells. Researchers are interested in determining whether AZD6...
What is the current status of trial NCT01134601?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2010-05-24. Estimated completion is 2012-10-22.
What interventions are being tested in trial NCT01134601?
The interventions under investigation include: Capecitabine (DRUG), Radiation Therapy (PROCEDURE), AZD6244 (DRUG).
Who is sponsoring clinical trial NCT01134601?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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