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NCT04105010 · ClinicalTrials.gov registry record · Phase 1
Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
A Phase 1 study, sponsored by Dizal Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 171
- Enrollment target
NCT04105010: Completed Phase 1 study, sponsored by Dizal Pharmaceuticals.
NCT04105010 is a Phase 1 study that has completed, run by Dizal Pharmaceuticals. The registered enrollment target is 171 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04105010, a Phase 1 study, has completed, sponsored by Dizal Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 171 participants
- Enrollment target
Study Summary
This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment. Phase 1 part: Around 20\~40 patients will be subsequently enrolled into 2 different dose ascending cohorts. Additional 10\~20 patients may be enrolled to further explore a selected dose defined by dose escalation cohorts. Phase 2 part: After the recommended phase 2 dose (RP2D) is defined, a phase 2 single-arm open-label pivotal study will be conducted to assess anti-tumor efficacy and safety of AZD4205 at RP2D in patients with refractory or relapsed PTCL.
Primary Outcome
ORR is the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) based on CT scans evaluated by IRC per Lugano criteria.
Interventions
- DRUG golidocitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 171 participants |
| Start Date | 2019-09-10 |
| Est. Completion | 2024-02-22 |
| Phase | Phase 1 |
What the finished NCT04105010 record still lists
NCT04105010 is an interventional study that assigns participants to a tested intervention. The registered 171 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (185% higher).
The record links to 0 conditions, and to 1 intervention - of which golidocitinib is the first listed.
NCT04105010 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04105010 about?
NCT04105010 is a clinical study titled "Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)". This is a multinational, non-randomized, open-label, Phase 1/2 clinical study to evaluate the safety, tolerability and anti-tumor efficacy of AZD4205 as monotherapy in patients with peripheral T cell lymphoma (PTCL), who have relapsed from or are refractory/intolerant to standard systemic treatment....
What is the current status of trial NCT04105010?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 171 participants. The study started on 2019-09-10. Estimated completion is 2024-02-22.
What interventions are being tested in trial NCT04105010?
The interventions under investigation include: golidocitinib (DRUG).
Who is sponsoring clinical trial NCT04105010?
This trial is sponsored by Dizal Pharmaceuticals, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04105010's enrollment target sits among peer trials
171 324th of 2000 higher than 1,676 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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