Trial · NCT01456039
A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL)
NCT01456039, Phase 1, Phase 2, Completed, Celgene; results first posted 2016-08-19
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ConductScience Library. A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL). Trials, record NCT01456039. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01456039
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Japanese Phase 1/2 Study to Assess the Efficacy, Safety and Pharmacokinetics of Romidepsin in Patients With Peripheral T-cell Lymphoma (PTCL)
- NCT number
- NCT01456039
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- Celgene
- Conditions
- Lymphoma, T-cell, Peripheral
- Interventions
- Romidepsin
- First posted
- 2011-10-20
- Last updated
- 2019-02-11
- Results first posted
- 2016-08-19
Source ClinicalTrials.gov
Registered outcomes24
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC) | Up to Day 28; Cycle 1 | DLT was defined as an adverse event (AE) occurring in Cycle 1 in Phase 1 and judged that the causal relationship to the investigational product could not be denied. The severity of all AEs was graded based upon the NCI CTCAE version 3.0. DLTs were defined as: • Grade 4 Hemoglobin \<6.5 g/dL • Grade 4 Neutrophil \<500/μL continuing for at least 5 days • Febrile neutropenia (Grade 4 neutropenia caused by fever and ≥ 38.5° C for more than 1 hour) • Grade 4 thrombocyte (\< 25,000/μL), or thrombocytopenia with hemorrhage requiring platelet transfusion • Nausea, vomiting, or diarrhea at \> grade 3 in spite of treatment • Grade 3 ALT (alanine aminotransferase) or AST (aspartate aminotransferase) values continued for 7 days. • Grade 4 ALT or AST • Grade 2 arrhythmia • Grade 4 non-hematological AEs • Other grade 3 non-hematological AEs except transient fatigue, anorexia, hyponatremia, and tumor lysis syndrome • Other AEs leading to discontinuation of administration |
| Primary | Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015 | Objective disease response in PTCL was defined as patients with a complete response (CR), unconfirmed complete response (CRu) or a partial response (PR) according to modified IWC 1999 criteria and assessed by an independent efficacy reviewer. A CR is \>75% decrease in size of maximum 6 largest target within nodal and extranodal lesions, complete disappearance of other nodal and extranodal; total disappearance of clinical disease; disease-related signs and symptoms, normalization of biochemical abnormalities, disappearance of spleen, liver, or kidney enlargement; no bone marrow (BM) involvement, no new sites of disease. CRu: all above criteria fulfilled except for BM involvement is indeterminate. PR: a ≥50% decrease in size of 6 largest target lesions and no increase other nodal and extranodal; no progression of clinical disease; disease-related signs and symptoms, normalization or biochemical abnormalities, no progression in size of liver, spleen, or kidney; and no new sites of disease |
| Secondary | Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum follow up time was 184.3 weeks | An adverse event (AE) is any noxious, unintended, or untoward medical occurrence that may appear or worsen during the course of a study. An AE that resulted in any of the outcomes was defined as a serious (SAE): • Death • Life-threatening event • An inpatient hospitalization or prolongation of existing hospitalization • Persistent or significant disability or incapacity; • Congenital anomaly or birth defect • Other important medical event The investigator judged the relationship of an AE to study drug based on the timing of the AE relative to drug administration and whether or not other drugs, therapeutic interventions, or underlying conditions could provide an explanation for the event. The severity of an AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (CTCAE Version 3.0), Japanese Clinical Oncology Group (JCOG) where Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, Grade 4 = Life-threatening and Grade 5 = Death. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | Area under the plasma concentration-time curve from time zero to the last quantifiable time point, calculated by the linear trapezoidal rule when concentrations are increasing and the logarithmic trapezoidal method when concentrations are decreasing. |
| Secondary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | Area under the plasma concentration-time curve from time zero extrapolated to infinity (AUC∞) of romidepsin on Day 1; if possible the area under the concentration-time curve from time zero to infinity, calculated by the linear trapezoidal rule and extrapolated to infinity was calculated according to the following equation: AUC∞ = AUCt + (Ct/ λz ), where Ct is the last quantifiable concentration. |
| Secondary | Maximum Plasma Concentration (Cmax) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | The maximum observed plasma concentration of romidepsin (Cmax) obtained directly from the observed concentration versus time data |
| Secondary | Time to Maximum Plasma Concentration of Romidepsin (Tmax) in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | The time to first maximum observed plasma concentration of romidepsin after a single dose on Day 1. |
| Secondary | Terminal Phase Half-life of Romidepsin (t½) in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration. | The terminal phase half-life of romidepsin after a single dose on Day 1, calculated according to the following equation: t½ = 0.693/λz, where λz is the terminal phase rate constant. |
| Secondary | Apparent Total Clearance of Romidepsin (CL/F) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration. | The apparent total clearance of romidepsin after a single dose on Day 1, calculated as dose/AUC0-infinity. |
| Secondary | Apparent Volume of Distribution (Vz/F) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | Apparent volume of distribution, was calculated according to the equation: Vd/F = (CL/F)/λz |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 registered outcomesOutcomes24
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC) | Up to Day 28; Cycle 1 | DLT population included all participants in the Phase 1 portion who received at least one dose of romidepsin. Of 8 participants enrolled in the 14mg/m\^2 cohort, 2 participants, one with a critical Good Clinical Practice (GCP)violation and the other who did not complete Cycle 1 due to consent withdrawal, were excluded from the DLT assessment. | participants | NUMBER |
| PRIMARY | Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Tumor assessments performed every 2 months; median follow-up time was 100 days; up to the data cut-off of 28 July 2015 | Intent to treat population for participants with PTCL who received at least one dose of Romidepsin | percentage of participants | NUMBER |
| SECONDARY | Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Day 1 of study drug through 30 days after the last dose of study drug or discontinuation date; Up to data cut-off of 28 July 2015; maximum follow up time was 184.3 weeks | Safety population includes all participants who received at least one dose of romidepsin | participants | NUMBER |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-t) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | PK Population consisted of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for romidepsin for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis. | ng*h/mL | GEOMETRIC_MEAN |
| SECONDARY | Maximum Plasma Concentration (Cmax) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | Pharmacokinetic (PK) Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis. | ng/mL | GEOMETRIC_MEAN |
| SECONDARY | Time to Maximum Plasma Concentration of Romidepsin (Tmax) in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis. | hours | MEDIAN |
| SECONDARY | Terminal Phase Half-life of Romidepsin (t½) in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration. | PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis. | hours | GEOMETRIC_MEAN |
| SECONDARY | Apparent Total Clearance of Romidepsin (CL/F) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration. | PK population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis. | L/h | GEOMETRIC_MEAN |
| SECONDARY | Apparent Volume of Distribution (Vz/F) of Romidepsin in Phase 1 | Day 1 at Cycle 1; collected at 0 (pre-dose), 1, 2, 3, and 4 (at the end of administration) hours after the start of administration, 0.25 (15 minutes), 0.5 (30 minutes), 1, 2, 4, 6, 20, and 44 hours after the end of administration | PK Population includes of all participants who had sufficient concentration-time data to enable the calculation of PK parameters for at least one PK day. For those who were determined to be noncompliant to receiving romidepsin, or for those with incomplete data, a decision to include the analysis was made on a case-by-case basis. | Liters | GEOMETRIC_MEAN |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 outcomesResults by group156
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC) | Phase 1: Cohort 1: Romidepsin 9mg/m^2 | 0 | participants | ||
Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC) | Phase 1: Cohort 2: Romidepsin 14mg/m^2 | 0 | participants | ||
| Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Phase 1: Romidepsin 9mg/m^2 | 0 | 95% Confidence Interval 0.000 to 0.000 | percentage of participants | |
| Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Phase 1: Romidepsin 14mg/m^2 | 66.7 | 95% Confidence Interval 28.947 to 100.000 | percentage of participants | |
| Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Phase 2: Romidepsin 14mg/m^2 | 42.5 | 95% Confidence Interval 27.180 to 57.820 | percentage of participants | |
| Percentage of PTCL Participants With an Overall Best Response in Accordance With a Modified International Workshop Response Criteria (IWC) 1999 in Phase 2 | Total: Romidepsin 14mg/m^2 | 45.7 | 95% Confidence Interval 31.258 to 60.046 | percentage of participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 9mg/m^2 | Any 1 TEAE | 3 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 1: Romidepsin 14mg/m^2 | Any 1 TEAE | 7 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Phase 2: Romidepsin 14mg/m^2 | Any 1 TEAE | 40 | participants | |
| Participants With Treatment-Emergent Adverse Events (TEAEs) Associated With Romidepsin | Total: Romidepsin 14mg/m^2 | Any 1 TEAE | 47 | participants |
1 to 10 of 156Source ClinicalTrials.gov
See all 156 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1 (First Step) | STARTED | Phase 1: Romidepsin 9mg/m^2 | 3 | |
| Phase 1 (First Step) | STARTED | Phase 1: Romidepsin 14mg/m^2 | 8 | |
| Phase 1 (First Step) | STARTED | Phase 2: Romidepsin 14mg/m^2 | 0 | |
| Phase 1 (First Step) | COMPLETED | Phase 1: Romidepsin 9mg/m^2 | 1 | |
| Phase 1 (First Step) | COMPLETED | Phase 1: Romidepsin 14mg/m^2 | 1 | |
| Phase 1 (First Step) | COMPLETED | Phase 2: Romidepsin 14mg/m^2 | 0 | |
| Phase 1 (First Step) | NOT COMPLETED | Phase 1: Romidepsin 9mg/m^2 | 2 | |
| Phase 1 (First Step) | NOT COMPLETED | Phase 1: Romidepsin 14mg/m^2 | 7 | |
| Phase 1 (First Step) | NOT COMPLETED | Phase 2: Romidepsin 14mg/m^2 | 0 | |
| Phase 2 (Second Step) | STARTED | Phase 1: Romidepsin 9mg/m^2 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events556
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: Romidepsin 9mg/m^2 | 3 | 3 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 1: Romidepsin 14mg/m^2 | 7 | 7 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Phase 2: Romidepsin 14mg/m^2 | 39 | 40 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Total: Romidepsin 14mg/m^2 | 46 | 47 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 1: Romidepsin 9mg/m^2 | 3 | 3 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 1: Romidepsin 14mg/m^2 | 7 | 7 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Phase 2: Romidepsin 14mg/m^2 | 34 | 40 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Total: Romidepsin 14mg/m^2 | 41 | 47 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1: Romidepsin 9mg/m^2 | 3 | 3 | |
| other | Leukopenia | Blood and lymphatic system disorders | Phase 1: Romidepsin 14mg/m^2 | 6 | 7 |
1 to 10 of 556Source ClinicalTrials.gov
See all 556 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Phase 1: Romidepsin 9mg/m^2 | ||
| Total, all-cause mortality | Phase 1: Romidepsin 14mg/m^2 | ||
| Total, all-cause mortality | Phase 2: Romidepsin 14mg/m^2 | ||
| Total, all-cause mortality | Total: Romidepsin 14mg/m^2 | ||
| Total, other adverse events | Phase 1: Romidepsin 9mg/m^2 | 3 | 3 |
| Total, other adverse events | Phase 1: Romidepsin 14mg/m^2 | 7 | 7 |
| Total, other adverse events | Phase 2: Romidepsin 14mg/m^2 | 40 | 40 |
| Total, other adverse events | Total: Romidepsin 14mg/m^2 | 47 | 47 |
| Total, serious adverse events | Phase 1: Romidepsin 9mg/m^2 | 1 | 3 |
| Total, serious adverse events | Phase 1: Romidepsin 14mg/m^2 | 4 | 7 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28664499 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
Phase 1: Cohort 1: Romidepsin 9mg/m^2 vs Phase 1: Cohort 2: Romidepsin 14mg/m^2: Number of Participants With Dose-limiting Toxicity (DLT) in Accordance With National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 as Determined by the Efficacy and Safety Evaluation Committee (ESEC) |
Source 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/NCT01456039
GET https://conductscience.org/api/trials/v1/NCT01456039/registered?page=2