Trial · NCT03572634
Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL
NCT03572634, Phase 1, Phase 2, Terminated, Sumitomo Pharma America, Inc.; results first posted 2021-02-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL. Trials, record NCT03572634. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03572634
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 1/2 Study of TP-0903 (an Inhibitor of AXL Kinase) in Patients With Previously Treated CLL
- NCT number
- NCT03572634
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Conditions
- Chronic Lymphocytic Leukemia, CLL, SLL, Small Lymphocytic Lymphoma
- Interventions
- TP-0903, TP-0903 and ibrutinib combination therapy
- First posted
- 2018-06-28
- Last updated
- 2023-11-09
- Results first posted
- 2021-02-02
- Limitations and caveats
- The study was stopped early (21 January 2020) due to low enrollment.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | PHASE 1: Incidence of Dose-limiting Toxicities (DLTs) and Treatment Emergent Adverse Events. | 28 days | A DLT is defined as a drug-related toxicity that is observed to occur within the first 28 days of treatment |
| Primary | PHASE 2: ORR in the Two Defined Patient Groups According to Guidelines Set Forth by the 2018 IWCLL | 3 months | Objective Response Rate (\[ORR\], ie, rate of complete response \[CR\] plus rate of partial response \[PR\] in the defined patient groups according to guidelines set forth by the 2018 International Workshop on CLL (IWCLL) |
| Secondary | PHASE 1: Area Under the Plasma Concentration-time Curve From Zero to Infinity of Oral TP-0903 in the Defined Patient Groups | 28 days | Blood samples will be collected from patients so that derived PK parameters by non-compartment analysis may be conducted on Cycle 1 |
| Secondary | PHASE 1: Peak Plasma Concentration (Cmax) of Oral TP-0903 in the Defined Patient Groups | 28 days | Blood samples will be collected from patients so that derived PK parameters by non-compartment analysis may be conducted on Cycle 1 |
| Secondary | PHASE 2: To Determine the Duration of Response | 2 years | Time from tumor response to disease progression |
| Secondary | PHASE 2: Rate of Overall Survival | 2 years | The time from first dose to objective tumor progression or death |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | PHASE 1: Incidence of Dose-limiting Toxicities (DLTs) and Treatment Emergent Adverse Events. | 28 days | Primary and secondary efficacy endpoints were not analyzed via statistical methods due to low enrollment in Phase 1 and no enrollment in Phase 2. | ||
| PRIMARY | PHASE 2: ORR in the Two Defined Patient Groups According to Guidelines Set Forth by the 2018 IWCLL | 3 months | Primary and secondary efficacy endpoints were not analyzed via statistical methods due to low enrollment in Phase 1 and no enrollment in Phase 2. | ||
| SECONDARY | PHASE 1: Area Under the Plasma Concentration-time Curve From Zero to Infinity of Oral TP-0903 in the Defined Patient Groups | 28 days | The study was stopped prematurely due to low enrollment across the 6 investigative sites. Efficacy endpoints could not be reached, and PK and PD test results could not be evaluated due to low sample size. | ||
| SECONDARY | PHASE 1: Peak Plasma Concentration (Cmax) of Oral TP-0903 in the Defined Patient Groups | 28 days | The study was stopped prematurely due to low enrollment across the 6 investigative sites. Efficacy endpoints could not be reached, and PK and PD test results could not be evaluated due to low sample size. | ||
| SECONDARY | PHASE 2: To Determine the Duration of Response | 2 years | The study was stopped prematurely due to early discontinuation of the study as a result of low enrollment. Efficacy endpoints could not be reached, and PK and PD test results could not be evaluated due to low sample size. 1 patient was enrolled in the Monotherapy group, 2 patients were enrolled in the Combination therapy group; 3 patients in total were enrolled in the study. | ||
| SECONDARY | PHASE 2: Rate of Overall Survival | 2 years | The study was stopped prematurely due to low enrollment across the 6 investigative sites. Efficacy endpoints could not be reached, and PK and PD test results could not be evaluated due to low sample size. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | TP-0903 Monotherapy (25mg Dose of TP-0903) | 1 | |
| Overall Study | STARTED | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 2 | |
| Overall Study | COMPLETED | TP-0903 Monotherapy (25mg Dose of TP-0903) | 1 | |
| Overall Study | COMPLETED | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 2 | |
| Overall Study | NOT COMPLETED | TP-0903 Monotherapy (25mg Dose of TP-0903) | 0 | |
| Overall Study | NOT COMPLETED | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 0 |
Source ClinicalTrials.gov
Adverse events100
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 | Hives | Skin and subcutaneous tissue disorders | TP-0903 Monotherapy (25mg Dose of TP-0903) | 1 | 1 | 1 |
| other | Hives | Skin and subcutaneous tissue disorders | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 0 | 2 | 0 |
| other | Geographic tongue with aphthous ulcers | Gastrointestinal disorders | TP-0903 Monotherapy (25mg Dose of TP-0903) | 1 | 1 | 1 |
| other | Geographic tongue with aphthous ulcers | Gastrointestinal disorders | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 0 | 2 | 0 |
| other | Nausea | Gastrointestinal disorders | TP-0903 Monotherapy (25mg Dose of TP-0903) | 1 | 1 | 1 |
| other | Nausea | Gastrointestinal disorders | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 1 | 2 | 3 |
| other | Pyrexia | General disorders | TP-0903 Monotherapy (25mg Dose of TP-0903) | 0 | 1 | 0 |
| other | Pyrexia | General disorders | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 1 | 2 | 2 |
| other | Decreased bilirubin level | Investigations | TP-0903 Monotherapy (25mg Dose of TP-0903) | 0 | 1 | 0 |
| other | Decreased bilirubin level | Investigations | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 1 | 2 | 1 |
1 to 10 of 100Source ClinicalTrials.gov
See all 100 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | TP-0903 Monotherapy (25mg Dose of TP-0903) | 0 | 1 |
| Total, all-cause mortality | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 0 | 2 |
| Total, other adverse events | TP-0903 Monotherapy (25mg Dose of TP-0903) | 1 | 1 |
| Total, other adverse events | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 2 | 2 |
| Total, serious adverse events | TP-0903 Monotherapy (25mg Dose of TP-0903) | 0 | 1 |
| Total, serious adverse events | TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903) | 2 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| TP-0903 Monotherapy (25mg Dose of TP-0903) vs TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903): deaths from any cause | Trial comparisons |
| TP-0903 Monotherapy (25mg Dose of TP-0903) vs TP-0903 and Ibrutinib Combination Therapy (20 mg Dose of TP-0903): serious adverse events | Trial comparisons |
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/NCT03572634
GET https://conductscience.org/api/trials/v1/NCT03572634/events?page=2