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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 is a Phase 1 study that has completed, run by Spectrum Pharmaceuticals. The registered enrollment target is 14 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00765973
The ClinicalTrials.gov registry entry for NCT00765973 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 14 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Spectrum Pharmaceuticals, which has 52 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Topotecan Liposomes Injection (TLI) is the first listed.
NCT00765973 reports 0 study locations.
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.
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