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NCT00765973 · ClinicalTrials.gov registry record · Phase 1
Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors
A Phase 1 study, sponsored by Spectrum Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 14
- Enrollment target
NCT00765973: Completed Phase 1 study, sponsored by Spectrum Pharmaceuticals.
NCT00765973 is a Phase 1 study that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 14 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00765973, a Phase 1 study, has completed, sponsored by Spectrum Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 14 participants
- Enrollment target
Study Summary
A multi-center, open-label, two-arm, dose-escalation study to establish the safety, tolerability, MTD, and schedule of TLI administered intravenously as a 30 minute infusion in adult subjects with advanced solid tumors that have relapsed, are refractory to standard therapy, or for whom there is no standard therapy available. The two dosing regimens to be evaluated are: * Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2) * Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2) When one of the two arms reaches MTD, all future subjects will then be enrolled in the remaining study arm until MTD of that arm is reached.
Interventions
- DRUG Topotecan Liposomes Injection (TLI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2008-11-10 |
| Est. Completion | 2010-06-30 |
| Phase | Phase 1 |
What the finished NCT00765973 record still lists
NCT00765973 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Topotecan Liposomes Injection (TLI) is the first listed.
NCT00765973 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00765973 about?
NCT00765973 is a clinical study titled "Topotecan Liposomes Injection for Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors". A multi-center, open-label, two-arm, dose-escalation study to establish the safety, tolerability, MTD, and schedule of TLI administered intravenously as a 30 minute infusion in adult subjects with advanced solid tumors that have relapsed, are refractory to standard therapy, or for whom there is no s...
What is the current status of trial NCT00765973?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 14 participants. The study started on 2008-11-10. Estimated completion is 2010-06-30.
What interventions are being tested in trial NCT00765973?
The interventions under investigation include: Topotecan Liposomes Injection (TLI) (DRUG).
Who is sponsoring clinical trial NCT00765973?
This trial is sponsored by Spectrum Pharmaceuticals, which has 52 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00765973's enrollment target sits among peer trials
14 1844th of 2000 higher than 154 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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