Trial · NCT00888927
Safety Study to Evaluate Monoclonal Antibody KW-0761 in Subjects With Peripheral T-cell Lymphoma
NCT00888927, Phase 1, Phase 2, Completed, Kyowa Kirin Co., Ltd.; results first posted 2020-12-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety Study to Evaluate Monoclonal Antibody KW-0761 in Subjects With Peripheral T-cell Lymphoma. Trials, record NCT00888927. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00888927
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety Study to Evaluate Monoclonal Antibody KW-0761 in Subjects With Peripheral T-cell Lymphoma
- NCT number
- NCT00888927
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Conditions
- Peripheral T-Cell Lymphoma
- Interventions
- KW-0761
- First posted
- 2009-04-28
- Last updated
- 2024-04-25
- Results first posted
- 2020-12-29
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose | 6 weeks | The objective was to find the maximum tolerated dose (MTD). In the dose escalation phase (Phase 1), the starting dose was 0.1 mg/kg administered intravenously once every week for four weeks, followed by a 2-week observation period in the first treatment course. Succeeding dose levels included 0.3 and 1.0 mg/kg. Standard 3+3 cohorts for safety and DLT detection were utilized. Each cohort consisted of at least three subjects. If Dose-Limiting Toxicity (DLT) was observed in 0/3 subjects, escalation to the next dose level occurred. |
| Secondary | Overall Response Rate (ORR) | one year | Overall Response Rate was determined based on the response in all compartments (lymph nodes, skin, and viscera) as follows: Complete Response (CR) = complete disappearance of all clinical evidence of disease; Partial Response (PR) = regression of measurable disease; Stable Disease (SD) = failure to attain CR, PR, or PD; Progressive Disease (PD) = PD in any compartment; Relapse = recurrence of disease in prior CR in any compartment. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose | 6 weeks | Safety Analysis set - Included all subjects who received at least one dose of KW-0761 (even a partial dose) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Overall Response Rate (ORR) | one year | Efficacy Analysis Set: all subjects who received at least four doses of KW-0761 and had at least one on-study assessment for response. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose | Phase 1 Cohort 1 | Subjects with any Dose-Limiting Toxicity (DLT) | 0 | Participants | |
| Maximum Tolerated Dose | Phase 1 Cohort 2 | Subjects with any Dose-Limiting Toxicity (DLT) | 0 | Participants | |
| Maximum Tolerated Dose | Phase 1 Cohort 3 | Subjects with any Dose-Limiting Toxicity (DLT) | 0 | Participants | |
| Maximum Tolerated Dose | Phase 2 | Subjects with any Dose-Limiting Toxicity (DLT) | 0 | Participants | |
| Maximum Tolerated Dose | Phase 1 Cohort 1 | Subjects with any treatment emergent adverse event (TEAE) | 3 | Participants | |
| Maximum Tolerated Dose | Phase 1 Cohort 2 | Subjects with any treatment emergent adverse event (TEAE) | 3 | Participants | |
| Maximum Tolerated Dose | Phase 1 Cohort 3 | Subjects with any treatment emergent adverse event (TEAE) | 3 | Participants | |
| Maximum Tolerated Dose | Phase 2 | Subjects with any treatment emergent adverse event (TEAE) | 32 | Participants | |
| Maximum Tolerated Dose | Phase 1 Cohort 1 | Subjects with any treatment-emergent serious adverse event | 0 | Participants | |
| Maximum Tolerated Dose | Phase 1 Cohort 2 | Subjects with any treatment-emergent serious adverse event | 1 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Phase 1 Cohort 1 | 3 | |
| Overall Study | STARTED | Phase 1 Cohort 2 | 3 | |
| Overall Study | STARTED | Phase 1 Cohort 3 | 3 | |
| Overall Study | STARTED | Phase 2 | 33 | |
| Overall Study | COMPLETED | Phase 1 Cohort 1 | 3 | |
| Overall Study | COMPLETED | Phase 1 Cohort 2 | 3 | |
| Overall Study | COMPLETED | Phase 1 Cohort 3 | 3 | |
| Overall Study | COMPLETED | Phase 2 | 31 | |
| Overall Study | NOT COMPLETED | Phase 1 Cohort 1 | 0 | |
| Overall Study | NOT COMPLETED | Phase 1 Cohort 2 | 0 |
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 | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1 Cohort 1 | 0 | 3 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1 Cohort 2 | 0 | 3 | 0 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1 Cohort 3 | 1 | 3 | 3 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 2 | 0 | 33 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1 Cohort 1 | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1 Cohort 2 | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 1 Cohort 3 | 0 | 3 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Phase 2 | 1 | 33 | 1 |
| other | Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | Phase 1 Cohort 1 | 0 | 3 | 0 |
| other | Lymphoid tissue hyperplasia | Blood and lymphatic system disorders | Phase 1 Cohort 2 | 0 | 3 | 0 |
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 | Phase 1 Cohort 1 | 0 | 3 |
| Total, all-cause mortality | Phase 1 Cohort 2 | 0 | 3 |
| Total, all-cause mortality | Phase 1 Cohort 3 | 1 | 3 |
| Total, all-cause mortality | Phase 2 | 2 | 33 |
| Total, other adverse events | Phase 1 Cohort 1 | 3 | 3 |
| Total, other adverse events | Phase 1 Cohort 2 | 3 | 3 |
| Total, other adverse events | Phase 1 Cohort 3 | 3 | 3 |
| Total, other adverse events | Phase 2 | 32 | 33 |
| Total, serious adverse events | Phase 1 Cohort 1 | 0 | 3 |
| Total, serious adverse events | Phase 1 Cohort 2 | 1 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25605368 | 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/NCT00888927
GET https://conductscience.org/api/trials/v1/NCT00888927/events?page=2