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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: Clinical Trial Phase 1 study, sponsored by Ascentage Pharma Group.
NCT04210037 is a Phase 1 study that was terminated before completion, run by Ascentage Pharma Group. The registered enrollment target is 28 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
DLT will be will be assessed via CTCAE version 5.0
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 |
Why NCT04210037 stopped before completion
NCT04210037 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (53% lower).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT04210037 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04210037's enrollment target sits among peer trials
28 1447th of 2000 higher than 538 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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