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NCT01284335 · ClinicalTrials.gov registry record · Phase 1
A Safety Study in Participants With Advanced Solid Tumors
A Phase 1 study, sponsored by Eli Lilly and Company.
- Terminated
- Registry status
- Phase 1
- Development phase
- 234
- Enrollment target
NCT01284335: Clinical Trial Phase 1 study, sponsored by Eli Lilly and Company.
NCT01284335 is a Phase 1 study that was terminated before completion, run by Eli Lilly and Company. The registered enrollment target is 234 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (290% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01284335, a Phase 1 study, was terminated before completion, sponsored by Eli Lilly and Company.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 234 participants
- Enrollment target
Study Summary
The purpose of this study is to determine a safe dose of LY573636 (tasisulam) when used in 5 separate combinations with an approved cancer medication for treating participants with advanced cancer. Data from this study will be reviewed for any side effects or anti-tumor activity that may be associated with the LY573636 combination treatments.
Primary Outcome
A Dose-Limiting Toxicity (DLT) is defined as an Adverse Event (AE) that is likely related to the study medication or combination, and fulfills any one of the following criteria: Common Terminology Criteria for Adverse Events (CTCAE, Version 3.0) Grade 4 neutropenia lasting more than 5 days. Grade 4 neutropenia with fever or Grade 4 thrombocytopenia, regardless of duration; Grade ≥3 thrombocytopenia with bleeding, regardless of duration; Grade ≥3 nonhematologic toxicity (excluding nausea/vomiting
Interventions
- DRUG Docetaxel
- DRUG Cisplatin
- DRUG Temozolomide
- DRUG Gemcitabine
- DRUG Erlotinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2008-07 |
| Est. Completion | 2016-05 |
| Phase | Phase 1 |
Why NCT01284335 stopped before completion
NCT01284335 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (290% higher).
The record links to 0 conditions, and to 5 interventions - of which Docetaxel is the first listed.
NCT01284335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01284335 about?
NCT01284335 is a clinical study titled "A Safety Study in Participants With Advanced Solid Tumors". The purpose of this study is to determine a safe dose of LY573636 (tasisulam) when used in 5 separate combinations with an approved cancer medication for treating participants with advanced cancer. Data from this study will be reviewed for any side effects or anti-tumor activity that may be associat...
What is the current status of trial NCT01284335?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 234 participants. The study started on 2008-07. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01284335?
The interventions under investigation include: Docetaxel (DRUG), Cisplatin (DRUG), Temozolomide (DRUG), Gemcitabine (DRUG), Erlotinib (DRUG).
Who is sponsoring clinical trial NCT01284335?
This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01284335's enrollment target sits among peer trials
234 212th of 2000 higher than 1,787 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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