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NCT04210037 · ClinicalTrials.gov registry record · Phase 1
Study of APG-1252 Plus Paclitaxel in Patients With Relapsed/Refractory Small Cell Lung Cancer
A Phase 1 study, sponsored by Ascentage Pharma Group.
- Terminated
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
NCT04210037 is a Phase 1 study that was terminated before completion, run by Ascentage Pharma Group. The registered enrollment target is 28 participants.
The verdict
NCT04210037, a Phase 1 study, was terminated before completion, sponsored by Ascentage Pharma Group.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
Study Summary
This is a multi-center, open-label, phase Ib/II study of combination therapy with APG-1252 plus paclitaxel in patients with relapsed/refractory small-cell lung cancer(SCLC). The phase Ib portion will be done using time-to-event continual reassessment method (TITE-CRM) methodology to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of APG-1252 with a fixed dose of paclitaxel. The phase II portion will utilize a Simon two-stage design to determine the efficacy of the combination therapy with response rate as the primary endpoint.
Interventions
- DRUG Paclitaxel
- DRUG APG-1252
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2020-08-20 |
| Est. Completion | 2022-05-15 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04210037
The ClinicalTrials.gov registry entry for NCT04210037 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ascentage Pharma Group, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT04210037 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04210037 about?
NCT04210037 is a clinical study titled "Study of APG-1252 Plus Paclitaxel in Patients With Relapsed/Refractory Small Cell Lung Cancer". This is a multi-center, open-label, phase Ib/II study of combination therapy with APG-1252 plus paclitaxel in patients with relapsed/refractory small-cell lung cancer(SCLC). The phase Ib portion will be done using time-to-event continual reassessment method (TITE-CRM) methodology to determine the ma...
What is the current status of trial NCT04210037?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2020-08-20. Estimated completion is 2022-05-15.
What interventions are being tested in trial NCT04210037?
The interventions under investigation include: Paclitaxel (DRUG), APG-1252 (DRUG).
Who is sponsoring clinical trial NCT04210037?
This trial is sponsored by Ascentage Pharma Group, which has 15 total clinical trials registered on ClinicalTrials.gov.
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