Trial · NCT00920790
Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
NCT00920790, Phase 2, Completed, Kyowa Kirin Co., Ltd.; results first posted 2012-09-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma. Trials, record NCT00920790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00920790
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase II Study of KW-0761 in Subjects With CCR4-positive Adult T-cell Leukemia-lymphoma
- NCT number
- NCT00920790
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 28 participants, actual
- Lead sponsor
- Kyowa Kirin Co., Ltd.
- Conditions
- Adult T-cell Leukemia-lymphoma
- Interventions
- KW-0761
- First posted
- 2009-06-15
- Last updated
- 2017-03-29
- Results first posted
- 2012-09-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Response Rate (ORR) | From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months. | Response rate defined as the proportion of responders relative to the total population and its exact 95% confidence interval were calculated for best overall response. The antitumor response criteria (Complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD)) were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG).Overall Response (OR)= CR + PR. |
| Primary | Pharmacokinetics-Plasma KW-0761 Concentrations | 0 to 7 days post final dose | Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling. The baseline and maximum time point at which Cmax and Ctrough were collected are 0 to 7 days post-dose. |
| Primary | Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days) | 0 to 7 days post final dose | Statistics of plasma KW-0761 concentrations were tabulated. Individual and mean (+standard deviation) plasma KW-0761 concentrations were plotted on a linear and a logarithmic scale against the time of blood sampling. |
| Primary | Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2) | 0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period). | |
| Secondary | Progression Free Survival (PFS) | Baseline to response | The time from the date of first KW-0761 dosing to the date of progressive disease(PD) confirmation or death. The antitumor response criteria including PD were created based on the criteria for non-Hodgkin's lymphoma and chronic lymphocytic leukemia provided in the National Comprehensive Cancer Network(NCCN) Clinical Practice Guidelines in Oncology as well as the criteria for non-Hodgkin's lymphoma by the Lymphoma Study Group of the Japan Clinical Oncology Group (JCOG-LSG). |
| Secondary | Overall Survival (OS) | Baseline to response | The time from the date of first KW-0761 dosing to the date of 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 | Overall Response Rate (ORR) | From date of first subject's consent to participate in the study until the date of last protocol-specified examination for last subject completed, assessed up to 14 months. | Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded. | percentage of participants with response | NUMBER |
| SECONDARY | Progression Free Survival (PFS) | Baseline to response | Of the 27 subjects enrolled, 26 were included in the efficacy analysis set, whereas 1 was excluded. | days | MEDIAN |
| SECONDARY | Overall Survival (OS) | Baseline to response | Of the 27 subjects enrolled, 26 were included in the overall survival analysis set, whereas 1 was excluded. | days | MEDIAN |
| PRIMARY | Pharmacokinetics-Plasma KW-0761 Concentrations | 0 to 7 days post final dose | Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set. | ng/mL | MEAN |
| PRIMARY | Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days) | 0 to 7 days post final dose | Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set. | ng·h/mL | MEAN |
| PRIMARY | Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2) | 0 to 28 days post final dose and follow-up examinations (1 month and 3 months after the end of the post-dosing observation period). | Of the 27 subjects enrolled, 27 were included in the pharmacokinetics analysis set. | hours | MEAN |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Response Rate (ORR) | KW-0761 | 50 | 95% Confidence Interval 29.9 to 70.1 | percentage of participants with response | |
| Progression Free Survival (PFS) | KW-0761 | 97 | Full Range 12 to 401 | days | |
| Overall Survival (OS) | KW-0761 | 176.5 | Full Range 101 to 401 | days | |
| Pharmacokinetics-Plasma KW-0761 Concentrations | KW-0761 | Cmax | 42943.2 | Standard Deviation 14239.5 | ng/mL |
| Pharmacokinetics-Plasma KW-0761 Concentrations | KW-0761 | Ctrough | 33638.3 | Standard Deviation 10572.2 | ng/mL |
| Pharmacokinetics-Plasma KW-0761 Concentrations (AUC0-7days) | KW-0761 | 6297408 | Standard Deviation 1812467 | ng·h/mL | |
| Pharmacokinetics-Plasma KW-0761 Concentrations (t1/2) | KW-0761 | 422 | Standard Deviation 147 | hours |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KW-0761 | 27 | |
| Overall Study | COMPLETED | KW-0761 | 13 | |
| Overall Study | NOT COMPLETED | KW-0761 | 14 |
Source ClinicalTrials.gov
Adverse events115
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 | Tachycardia | Cardiac disorders | KW-0761 | 8 | 27 | |
| other | Ventricular extrasystoles | Cardiac disorders | KW-0761 | 2 | 27 | |
| other | Cardiac failure congestive | Cardiac disorders | KW-0761 | 1 | 27 | |
| other | Left ventricular dysfunction | Cardiac disorders | KW-0761 | 1 | 27 | |
| other | Hypoacusis | Ear and labyrinth disorders | KW-0761 | 1 | 27 | |
| other | Left atrial dilatation | Cardiac disorders | KW-0761 | 1 | 27 | |
| other | Conjunctivitis | Eye disorders | KW-0761 | 1 | 27 | |
| other | Eye pruritus | Eye disorders | KW-0761 | 1 | 27 | |
| other | Nausea | Gastrointestinal disorders | KW-0761 | 5 | 27 | |
| other | Vomiting | Gastrointestinal disorders | KW-0761 | 5 | 27 |
1 to 10 of 115Source ClinicalTrials.gov
See all 115 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KW-0761 | ||
| Total, other adverse events | KW-0761 | 27 | 27 |
| Total, serious adverse events | KW-0761 | 6 | 27 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22312108 | RESULT |
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/NCT00920790
GET https://conductscience.org/api/trials/v1/NCT00920790/events?page=2