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NCT04586335 · ClinicalTrials.gov registry record · Phase 1
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
A Phase 1 study, sponsored by Haihe Biopharma Co..
- Terminated
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT04586335: Clinical Trial Phase 1 study, sponsored by Haihe Biopharma Co..
NCT04586335 is a Phase 1 study that was terminated before completion, run by Haihe Biopharma Co.. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04586335, a Phase 1 study, was terminated before completion, sponsored by Haihe Biopharma Co..
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CYH33 in combination with olaprib in patients with DDR gene mutations and/or PIK3CA mutations, in patients who have progressed on prior PARP inhibitor, and in patients with recurrent high grade serous ovarian, fallopian tube, or primary peritoneal cancer who are platinum resistant or refractory. The study will assess if this combination will optimize anti-tumor activity, block tumor growth and overcome the resistance to PARP inhibitor treatment. The study consists 2 parts. In Part 1 dose escalation, the objective is to determine the maximum toleration dose (MTD) of the combination. The final recommended phase 2 dose (RP2D) of CYH33 in combination with olaparib will be based on the totality of an overall assessment of available safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy which could be the MTD or a dose level lower in specific cohorts of patients. In Part 2 dose expansion, the main objective is to evaluate the efficacy at RP2D.
Primary Outcome
Incidence rate of dose limiting toxicities (DLT) in the first cycle (of 28 days) of each investigated dose levels.
Interventions
- DRUG CYH33
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2020-09-28 |
| Est. Completion | 2023-02-15 |
| Phase | Phase 1 |
Why NCT04586335 stopped before completion
NCT04586335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which CYH33 is the first listed.
NCT04586335 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04586335 about?
NCT04586335 is a clinical study titled "Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.". The purpose of this study is to assess the safety, tolerability and preliminary efficacy of CYH33 in combination with olaprib in patients with DDR gene mutations and/or PIK3CA mutations, in patients who have progressed on prior PARP inhibitor, and in patients with recurrent high grade serous ovarian...
What is the current status of trial NCT04586335?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2020-09-28. Estimated completion is 2023-02-15.
What interventions are being tested in trial NCT04586335?
The interventions under investigation include: CYH33 (DRUG).
Who is sponsoring clinical trial NCT04586335?
This trial is sponsored by Haihe Biopharma Co., which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04586335's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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