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NCT01675128 · ClinicalTrials.gov registry record · Phase 1
ISIS 183750 With Irinotecan for Advanced Solid Tumors or Colorectal Cancer
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT01675128: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT01675128 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01675128, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Background: \- Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the deoxyribonucleic acid (DNA) of growing cancer cells. It is most often used with other chemotherapy drugs. Researchers want to test it with an experimental drug, ISIS 183750. They want to see if the drugs are a safe and effective treatment for advanced solid tumors or colorectal cancer that has not responded to other treatments. Objectives: \- To test the safety and effectiveness of ISIS 183750 with irinotecan for advanced solid tumors or colorectal cancer. Eligibility: \- Individuals at least 18 years of age who have solid tumors or colorectal cancer that has not responded to other treatments. Design: * Participants will be screened with a physical exam and medical history. Blood and urine samples will also be collected. Tumor tissue samples may be collected as well before and after treatment. Imaging studies will also be performed. * Participants will take ISIS 183750 once a week for 28-day cycles of treatment. On the first cycle, they will also have ISIS 183750 on days 3 and 5. * Participants will take irinotecan every second week, beginning on day 15 of the first cycle. * Treatment will be monitored with frequent blood tests and imaging studies. * Treatment will continue as long as the cancer does not grow and the side effects are not severe.
Primary Outcome
MTD is the dose level at which no more than 1 of up to 6 patients experience dose-limiting toxicity (DLT) during the first 6 weeks of treatment, and no dose below that which at least 2 (of \</=6) patients have DLT as a result of the drug.
Interventions
- DRUG Irinotecan
- DRUG ISIS 183750
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2012-08 |
| Est. Completion | 2015-12 |
| Phase | Phase 1 |
What the finished NCT01675128 record still lists
NCT01675128 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which Irinotecan is the first listed.
NCT01675128 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01675128 about?
NCT01675128 is a clinical study titled "ISIS 183750 With Irinotecan for Advanced Solid Tumors or Colorectal Cancer". Background: \- Irinotecan is a drug that is used to treat colon or rectal cancer. It affects the deoxyribonucleic acid (DNA) of growing cancer cells. It is most often used with other chemotherapy drugs. Researchers want to test it with an experimental drug, ISIS 183750. They want to see if the drug...
What is the current status of trial NCT01675128?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2012-08. Estimated completion is 2015-12.
What interventions are being tested in trial NCT01675128?
The interventions under investigation include: Irinotecan (DRUG), ISIS 183750 (DRUG).
Who is sponsoring clinical trial NCT01675128?
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 NCT01675128's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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