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NCT01554969 · ClinicalTrials.gov registry record · Phase 1
Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer
A Phase 1 study of Rectal Cancer, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT01554969: Completed Phase 1 study of Rectal Cancer, sponsored by Emory University.
NCT01554969 is a Phase 1 study of Rectal Cancer that has completed, run by Emory University. The registered enrollment target is 16 participants, below the 3,167-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01554969, a Phase 1 study of Rectal Cancer, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to find out what effects, good and/or bad, the combination of the study drug, capecitabine, and radiation have on you and your cancer. Capecitabine, radiation, and the study drug kill cancer cells in different ways. Giving these treatments together may make your cancer shrink or slow down its growth more than it would if you got treated with capecitabine and radiation alone. This is a Phase I drug study of ganetespib given together with capecitabine and radiation in patients with locally advanced rectal cancer. Ganetespib is an experimental drug; not approved by the Food and Drug Administration (FDA). The other two, capecitabine and radiation, are approved by FDA for use in rectal cancer. In this study, the investigators will test different dosages of the "investigational" (experimental) drug, called ganetespib (the study drug). The study drug is "investigational" because it is not approved by the FDA for use. The study drug has been previously tested in humans. The study uses a well-established process of slowly increasing drug dosage to determine the highest dosage that can be given without causing serious side effects. In addition, the study will help researchers to determine what the side effects and drug interactions might be. The study will also look at the drug's pharmacokinetics (PK). PK is how the study drug and capecitabine with radiation work in your body (for example how long the drugs last in your body.)
Primary Outcome
Changes in only the largest diameter (unidimensional measurement) of the tumor lesions are used in the RECIST criteria.
Conditions Studied
Interventions
- DRUG capecitabine + ganetespib
Study Locations (1)
Georgia
- Emory University Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2012-05 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT01554969 record still lists
NCT01554969 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 3,167-participant average among 70 other Rectal Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Rectal Cancer appearing as the primary indexed condition, and to 1 intervention - of which capecitabine + ganetespib is the first listed.
NCT01554969 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT01554969 about?
NCT01554969 is a clinical study titled "Phase I Trial of Ganetespib, Capecitabine, and Radiation in Rectal Cancer". The purpose of this study is to find out what effects, good and/or bad, the combination of the study drug, capecitabine, and radiation have on you and your cancer. Capecitabine, radiation, and the study drug kill cancer cells in different ways. Giving these treatments together may make your cancer s...
What is the current status of trial NCT01554969?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2012-05. Estimated completion is 2015-06.
What conditions does trial NCT01554969 study?
This clinical trial studies the following conditions: Rectal Cancer.
What interventions are being tested in trial NCT01554969?
The interventions under investigation include: capecitabine + ganetespib (DRUG).
Who is sponsoring clinical trial NCT01554969?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01554969 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01554969's enrollment target sits among peer trials
16 67th of 70 higher than 4 of 70 other Rectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Rectal Cancer 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.
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