Trial · NCT04105010
Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
NCT04105010, Phase 1, Phase 2, Completed, Dizal Pharmaceuticals; results first posted 2025-04-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8). Trials, record NCT04105010. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04105010
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Assessing An Oral Janus Kinase Inhibitor, AZD4205 as Monotherapy in Patients Who Have PTCL (JACKPOT8)
- NCT number
- NCT04105010
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 171 participants, actual
- Lead sponsor
- Dizal Pharmaceuticals
- Conditions
- Relapsed or Refractory Peripheral T Cell Lymphoma
- Interventions
- golidocitinib
- First posted
- 2019-09-26
- Last updated
- 2025-04-04
- Results first posted
- 2025-04-04
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC) | Up to approximately 3 years | 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. |
| Secondary | Part A and Part B: Number of Participants With Adverse Events | The first dose until 28 days after last dose, up to approximately 3 years | To evaluate the safety and tolerability of AZD4205 in patients with PTCL in terms of adverse events (AEs), such as number of participants with AEs |
| Secondary | Part B: Duration of Response (DoR) Assessed by IRC | Up to approximately 3 years | DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT scans evaluated by IRC per Lugano criteria. |
| Secondary | Part B: Complete Response Rate (CRR) Assessed by IRC | Up to approximately 3 years | CRR is the percentage of patients with at least one visit response of CR based on CT scans evaluated by IRC per Lugano criteria. |
| Secondary | Part B: Progression Free Survival (PFS) Assessed by IRC | Up to approximately 3 years | PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT scans evaluated by IRC per Lugano criteria. |
| Secondary | Part B: Time to Response (TTR) Assessed by IRC | Up to approximately 3 years | TTR is the time from the date of first dosing to the time of the initial response of PR or CR. Response is identified based on CT scans evaluated by IRC per Lugano criteria. |
| Secondary | Part A and Part B: ORR Assessed by Investigator | Up to approximately 3 years | ORR is the percentage of patients with at least one visit response of CR or PR based on CT and/or PET scans evaluated by investigator per Lugano criteria. |
| Secondary | Part A and Part B: DoR Assessed by Investigator | Up to approximately 3 years | DoR is the time from the date of first documented response until the date of documented progression or death due to any cause. Documented response and progression are both identified based on CT and/or PET scans evaluated by investigator per Lugano criteria. |
| Secondary | Part A and Part B: CRR Assessed by Investigator | Up to approximately 3 years | CRR is the percentage of patients with at least one visit response of CR based on CT and/or PET scans evaluated by investigator per Lugano criteria. |
| Secondary | Part A and Part B: PFS Assessed by Investigator | Up to approximately 3 years | PFS is the time from the date of first dosing until the date of objective disease progression or death (by any cause) regardless of whether the participant discontinues the study treatments. Progression is identified based on CT and/or PET scans evaluated by investigator per Lugano criteria. |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC) | Up to approximately 3 years | Evaluable for CT-based Response Set (all dosed and central pathology confirmed Peripheral T Cell Lymphoma (PTCL) patients with baseline measurable disease assessed by IRC using CT imaging) | percentage of participants | NUMBER |
| SECONDARY | Part A and Part B: Number of Participants With Adverse Events | The first dose until 28 days after last dose, up to approximately 3 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Part B: Duration of Response (DoR) Assessed by IRC | Up to approximately 3 years | Subset of CR or PR responders in Evaluable for CT-based Response Set | months | MEDIAN |
| SECONDARY | Part B: Complete Response Rate (CRR) Assessed by IRC | Up to approximately 3 years | Evaluable for CT-based Response Set | percentage of participants | NUMBER |
| SECONDARY | Part B: Progression Free Survival (PFS) Assessed by IRC | Up to approximately 3 years | Evaluable for Survival Set (all dosed and central pathology confirmed PTCL patients) | months | MEDIAN |
| SECONDARY | Part B: Time to Response (TTR) Assessed by IRC | Up to approximately 3 years | Subset of CR or PR responders in Evaluable for CT-based Response Set | months | MEDIAN |
| SECONDARY | Part A and Part B: ORR Assessed by Investigator | Up to approximately 3 years | Part A: Evaluable for Response Set (All dosed patients with baseline measurable disease) Part B: Evaluable for CT-based Response Set | percentage of participants | NUMBER |
| SECONDARY | Part A and Part B: DoR Assessed by Investigator | Up to approximately 3 years | Part A: Subset of CR or PR responders in Evaluable for Response Set Part B: Subset of CR or PR responders in Evaluable for CT-based Response Set | months | MEDIAN |
| SECONDARY | Part A and Part B: CRR Assessed by Investigator | Up to approximately 3 years | Part A: Evaluable for Response Set Part B: Evaluable for CT-based Response Set | percentage of participants | NUMBER |
| SECONDARY | Part A and Part B: PFS Assessed by Investigator | Up to approximately 3 years | Part A: Safety Analysis Set Part B: Evaluable for Survival Set | months | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group42
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part B: CT-based Objective Response Rate (ORR) by Independent Review Committee (IRC) | AZD4205 Group D | 43.1 | 95% Confidence Interval 33.4 to 53.3 | percentage of participants | |
| Part A and Part B: Number of Participants With Adverse Events | AZD4205 Group A | 26 | Participants | ||
| Part A and Part B: Number of Participants With Adverse Events | AZD4205 Group B | 16 | Participants | ||
| Part A and Part B: Number of Participants With Adverse Events | AZD4205 Group C | 6 | Participants | ||
| Part A and Part B: Number of Participants With Adverse Events | AZD4205 Group D | 115 | Participants | ||
| Part B: Duration of Response (DoR) Assessed by IRC | AZD4205 Group D | NA | 95% Confidence Interval 16.6 to NA | months | |
| Part B: Complete Response Rate (CRR) Assessed by IRC | AZD4205 Group D | 21.6 | 95% Confidence Interval 14.0 to 30.8 | percentage of participants | |
| Part B: Progression Free Survival (PFS) Assessed by IRC | AZD4205 Group D | 5.5 | 95% Confidence Interval 3.0 to 18.7 | months | |
| Part B: Time to Response (TTR) Assessed by IRC | AZD4205 Group D | 1.4 | 95% Confidence Interval 1.4 to 1.5 | months | |
| Part A and Part B: ORR Assessed by Investigator | AZD4205 Group A | 46.4 | 95% Confidence Interval 27.5 to 66.1 | percentage of participants |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AZD4205 Group A | 28 | |
| Overall Study | STARTED | AZD4205 Group B | 16 | |
| Overall Study | STARTED | AZD4205 Group C | 7 | |
| Overall Study | STARTED | AZD4205 Group D | 120 | |
| Overall Study | COMPLETED | AZD4205 Group A | 13 | |
| Overall Study | COMPLETED | AZD4205 Group B | 7 | |
| Overall Study | COMPLETED | AZD4205 Group C | 5 | |
| Overall Study | COMPLETED | AZD4205 Group D | 39 | |
| Overall Study | NOT COMPLETED | AZD4205 Group A | 15 | |
| Overall Study | NOT COMPLETED | AZD4205 Group B | 9 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events644
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Platelet count decreased | Investigations | AZD4205 Group A | 9 | 28 | |
| other | Platelet count decreased | Investigations | AZD4205 Group B | 7 | 16 | |
| other | Platelet count decreased | Investigations | AZD4205 Group C | 0 | 7 | |
| other | Platelet count decreased | Investigations | AZD4205 Group D | 71 | 120 | |
| other | Neutrophil count decreased | Investigations | AZD4205 Group A | 6 | 28 | |
| other | Neutrophil count decreased | Investigations | AZD4205 Group B | 7 | 16 | |
| other | Neutrophil count decreased | Investigations | AZD4205 Group C | 1 | 7 | |
| other | Neutrophil count decreased | Investigations | AZD4205 Group D | 62 | 120 | |
| other | White blood cell count decreased | Investigations | AZD4205 Group A | 6 | 28 | |
| other | White blood cell count decreased | Investigations | AZD4205 Group B | 4 | 16 |
1 to 10 of 644Source ClinicalTrials.gov
See all 644 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AZD4205 Group A | 3 | 28 |
| Total, all-cause mortality | AZD4205 Group B | 2 | 16 |
| Total, all-cause mortality | AZD4205 Group C | 1 | 7 |
| Total, all-cause mortality | AZD4205 Group D | 54 | 120 |
| Total, other adverse events | AZD4205 Group A | 26 | 28 |
| Total, other adverse events | AZD4205 Group B | 16 | 16 |
| Total, other adverse events | AZD4205 Group C | 6 | 7 |
| Total, other adverse events | AZD4205 Group D | 114 | 120 |
| Total, serious adverse events | AZD4205 Group A | 12 | 28 |
| Total, serious adverse events | AZD4205 Group B | 9 | 16 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38092009 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04105010
GET https://conductscience.org/api/trials/v1/NCT04105010/results?page=2