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NCT02649673 · ClinicalTrials.gov registry record · Phase 1
LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies
A Phase 1 study, sponsored by SCRI Development Innovations.
- Terminated
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
NCT02649673: Clinical Trial Phase 1 study, sponsored by SCRI Development Innovations.
NCT02649673 is a Phase 1 study that was terminated before completion, run by SCRI Development Innovations. The registered enrollment target is 34 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02649673, a Phase 1 study, was terminated before completion, sponsored by SCRI Development Innovations.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
Study Summary
This trial will investigate the combination of two anti-cancer agents to treat patients with relapsed/refractory small cell lung cancer (SCLC) and ovarian cancers. Oral topotecan has US FDA approval for treating select gynecological cancers and SCLC. LCL161 is an investigational product that has been shown in clinical trials to work together with other anti-cancer agents. In this trial, investigators will determine the optimal dose of LCL161 and topotecan to administer to patients with relapsed/refractory SCLC and ovarian cancers, and examine the safety profile of the drug combination.
Primary Outcome
The maximum tolerated dose (MTD) of the LCL161/topotecan combination is defined as the highest dose that results in dose-limiting toxicities (DLTs) for 2 of 6 patients during the first 21 days (1 cycle) of treatment, assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.
Interventions
- DRUG Topotecan
- DRUG LCL161
- DRUG Pegylated GCSF (PEG-GCSF)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-03-23 |
| Est. Completion | 2021-07-30 |
| Phase | Phase 1 |
Why NCT02649673 stopped before completion
NCT02649673 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 3 interventions - of which Topotecan is the first listed.
NCT02649673 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02649673 about?
NCT02649673 is a clinical study titled "LCL161 Plus Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies". This trial will investigate the combination of two anti-cancer agents to treat patients with relapsed/refractory small cell lung cancer (SCLC) and ovarian cancers. Oral topotecan has US FDA approval for treating select gynecological cancers and SCLC. LCL161 is an investigational product that has bee...
What is the current status of trial NCT02649673?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2016-03-23. Estimated completion is 2021-07-30.
What interventions are being tested in trial NCT02649673?
The interventions under investigation include: Topotecan (DRUG), LCL161 (DRUG), Pegylated GCSF (PEG-GCSF) (DRUG).
Who is sponsoring clinical trial NCT02649673?
This trial is sponsored by SCRI Development Innovations, which has 146 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02649673's enrollment target sits among peer trials
34 1273rd of 2000 higher than 721 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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