Trial · NCT01007448
Study Evaluating Two Dose Levels of Targretin Capsules in Participants With Refractory Cutaneous T-Cell Lymphoma (CTCL)
NCT01007448, Phase 4, Completed, Bausch Health Americas, Inc.; results first posted 2019-11-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study Evaluating Two Dose Levels of Targretin Capsules in Participants With Refractory Cutaneous T-Cell Lymphoma (CTCL). Trials, record NCT01007448. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01007448
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study Evaluating Two Dose Levels of Targretin Capsules in Participants With Refractory Cutaneous T-Cell Lymphoma (CTCL)
- NCT number
- NCT01007448
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 59 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Refractory Cutaneous T-cell Lymphoma
- Interventions
- Bexarotene
- First posted
- 2009-11-04
- Last updated
- 2019-11-12
- Results first posted
- 2019-11-12
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Baseline up to Week 24 | Index lesion symptoms/grade include: erythema=0 (no evidence)-8 (very severe); scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence of change)-8 (very severe change); area of involvement=0 (0 centimeters \[cm\]\^2)-18 (\>300 cm\^2). CA generated by sum of grades of signs/symptoms for each index lesion. Index lesion CA grade at baseline was divided into CA grade at each subsequent study visit to determine participant's response to treatment. Ratio of CA \<1.0=improvement in disease; ratio \>1.0=worsening of disease. Tumor response as determined by CA=percentage of participants achieving CR (CA ratio=0, no clinically abnormal lymph nodes, and absence of histologic signs of CTCL); CCR (CA ratio=0 and no clinically abnormal lymph nodes); and PR (CA ratio=≤0.5, \<25% increase in number/aggregate area of abnormal lymph nodes/tumors, and no new abnormal lymph nodes in documented area of absence of disease). |
| Primary | Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition | Baseline up to Week 24 | The PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear \[≥90%-\<100%\] of disease since Baseline), 2 (marked improvement \[≥75%-\<90%\] of disease since Baseline), 3 (moderate improvement \[≥50%-\<70%\] of disease since Baseline). Stable Disease (SD)=PGA grade of 4 (slight improvement \[\<25%-\<50%\] of disease since Baseline) or 5 (no change in disease \[+/-\<25% change since Baseline\]). Progressive Disease (PD)=PGA grade of 6 (worse disease \[≥25%\] than at baseline). If visceral disease or an abnormal lymph node was located in a documented area of absence of disease, then PD would be reported for the participant. |
| Primary | Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined Percent Body Surface Area (BSA) Involvement | Baseline up to Week 24 | To determine BSA involvement, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. SD=none of the response classifications (that is, CR, CCR, PR, or PD) accurately describe the disease status. PD=an increase from Baseline in percent BSA of at least 25%. |
| Secondary | Duration of Tumor Response (CR, CCR, or PR) as Determined by Investigator's CA of Index Lesion Disease Severity | Baseline up to Week 24 | Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); area of involvement=0 (0 cm\^2)-18 (\>300 cm\^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio \<1.0=improvement and \>1.0=worsening of disease. Tumor response=percentage of participants with CR (CA ratio=0, no clinically abnormal lymph nodes, absence of CTCL histologic signs); CCR (CA ratio=0; no clinically abnormal lymph nodes); PR (CA ratio=≤0.5, \<25% increase in number/aggregate area of abnormal lymph nodes/tumors, no new abnormal lymph nodes in documented area of absence of disease). |
| Secondary | Duration of Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | Baseline up to Week 24 | Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear \[≥90%-\<100%\] of disease since Baseline), 2 (marked improvement \[≥75%-\<90%\] of disease since Baseline), 3 (moderate improvement \[≥50%-\<70%\] of disease since Baseline). |
| Secondary | Duration of Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | Baseline up to Week 24 | Defined as time interval from onset of response to time participant relapses or last date of data collected with an assessment of participant still meeting response criteria. To determine BSA, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. |
| Secondary | Time to Tumor Response (CR, CCR, or PR) as Determined by CA of Index Lesion Disease Severity | Baseline up to Week 24 | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); and area of involvement=0 (0 cm\^2)-18 (\>300 cm\^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio \<1.0=improvement and \>1.0=worsening of disease. Tumor response=percentage of participants with CR (CA ratio=0, no clinically abnormal lymph nodes, and absence of CTCL histologic signs); CCR (CA ratio=0 and no clinically abnormal lymph nodes); and PR (CA ratio=≤0.5, \<25% increase in number/aggregate area of abnormal lymph nodes/tumors, and no new abnormal lymph nodes in documented area of absence of disease). |
| Secondary | Time to Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | Baseline up to Week 24 | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. PGA was an assessment of the overall extent of improvement/worsening from Baseline of the participant's overall disease compared with the condition every 4 weeks thereafter during treatment. CR=PGA grade of 0 (completely clear of disease since Baseline) and absence of histologic signs of CTCL. CCR=PGA grade of 0. PR=PGA grade of 1 (almost clear \[≥90%-\<100%\] of disease since Baseline), 2 (marked improvement \[≥75%-\<90%\] of disease since Baseline), 3 (moderate improvement \[≥50%-\<70%\] of disease since Baseline). |
| Secondary | Time to Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | Baseline up to Week 24 | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met the criteria of CR, CCR, or PR. To determine BSA, the area of the participant's palm was defined as 1% of the participant's BSA. The extent of involvement of disease was determined as multiples of the participant's palm area and expressed as a percentage of the participant's total BSA at Baseline (Day 1) and every 4 weeks thereafter during treatment. CR=percent BSA 0% and documented absence of histologic signs of CTCL. CCR=Percent BSA 0%. PR=a decrease from Baseline in percent BSA of at least 50%. |
| Secondary | Time to Tumor Progression as Determined by CA of Index Lesion Disease Severity | Baseline up to Week 24 | Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. Index lesion symptoms/grade: erythema/scaling=0 (no evidence)-8 (very severe); plaque elevation=0 (no evidence)-8 (extreme elevation); hypopigmentation/hyperpigmentation=0 (no evidence)-8 (very severe change); and area of involvement=0 (0 cm\^2)-18 (\>300 cm\^2). CA: sum of signs/symptoms grades for index lesion. Index lesion CA grade at baseline divided into CA grade at study visit to determine treatment response. CA Ratio \<1.0=improvement and \>1.0=worsening of disease. Criteria for PD requires at least 1 component of the following: CA ratio=≥1.25, ≥25% increase in number/aggregate area of abnormal lymph nodes/tumors, or no new abnormal lymph nodes in documented area of absence of disease. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
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 Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined Percent Body Surface Area (BSA) Involvement | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Tumor Response (CR, CCR, or PR) as Determined by Investigator's CA of Index Lesion Disease Severity | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for CA of index lesion disease severity. | days | MEAN |
| SECONDARY | Duration of Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for PGA of clinical condition. | days | MEAN |
| SECONDARY | Duration of Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for percent of BSA involvement. | days | MEAN |
| SECONDARY | Time to Tumor Response (CR, CCR, or PR) as Determined by CA of Index Lesion Disease Severity | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for CA of index lesion disease severity. | days | MEAN |
| SECONDARY | Time to Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for PGA of clinical condition. | days | MEAN |
| SECONDARY | Time to Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population) and with the best overall response of evaluable CR, CCR, and PR data for percent of BSA involvement. | days | MEAN |
| SECONDARY | Time to Tumor Progression as Determined by CA of Index Lesion Disease Severity | Baseline up to Week 24 | Participants who received at least 1 dose of study drug (Full Analysis Population) and with evaluable PD data for CA of index lesion disease severity. | days | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group47
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 Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Bexarotene 150 mg/m^2/Day | CR | 0 | Participants | |
Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Bexarotene 300 mg/m^2/Day | CR | 0 | Participants | |
Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Bexarotene 150 mg/m^2/Day | CCR | 2 | Participants | |
Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Bexarotene 300 mg/m^2/Day | CCR | 3 | Participants | |
Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Bexarotene 150 mg/m^2/Day | PR | 5 | Participants | |
Number of Participants With Tumor Response (Complete Response [CR], Clinical Complete Response [CCR], and Partial Response [PR]) in up to 5 Index Lesions as Determined by Investigator's Composite Assessment (CA) of Index Lesion Disease Severity | Bexarotene 300 mg/m^2/Day | PR | 7 | Participants | |
| Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition | Bexarotene 150 mg/m^2/Day | CR | 0 | Participants | |
| Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition | Bexarotene 300 mg/m^2/Day | CR | 0 | Participants | |
| Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition | Bexarotene 150 mg/m^2/Day | CCR | 1 | Participants | |
| Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition | Bexarotene 300 mg/m^2/Day | CCR | 3 | Participants |
1 to 10 of 47Source ClinicalTrials.gov
See all 47 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bexarotene 150 mg/m^2/Day | 30 | |
| Overall Study | STARTED | Bexarotene 300 mg/m^2/Day | 29 | |
| Overall Study | Full Analysis Population | Bexarotene 150 mg/m^2/Day | 30 | |
| Overall Study | Full Analysis Population | Bexarotene 300 mg/m^2/Day | 29 | |
| Overall Study | Safety Population | Bexarotene 150 mg/m^2/Day | 30 | |
| Overall Study | Safety Population | Bexarotene 300 mg/m^2/Day | 29 | |
| Overall Study | COMPLETED | Bexarotene 150 mg/m^2/Day | 20 | |
| Overall Study | COMPLETED | Bexarotene 300 mg/m^2/Day | 20 | |
| Overall Study | NOT COMPLETED | Bexarotene 150 mg/m^2/Day | 10 | |
| Overall Study | NOT COMPLETED | Bexarotene 300 mg/m^2/Day | 9 |
Source ClinicalTrials.gov
Adverse events116
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 | Hypertriglyceridemia | Metabolism and nutrition disorders | Bexarotene 150 mg/m^2/Day | 17 | 30 | |
| other | Hypertriglyceridemia | Metabolism and nutrition disorders | Bexarotene 300 mg/m^2/Day | 14 | 29 | |
| other | Hypothyroidism | Endocrine disorders | Bexarotene 150 mg/m^2/Day | 12 | 30 | |
| other | Hypothyroidism | Endocrine disorders | Bexarotene 300 mg/m^2/Day | 15 | 29 | |
| other | Headache | Nervous system disorders | Bexarotene 150 mg/m^2/Day | 7 | 30 | |
| other | Headache | Nervous system disorders | Bexarotene 300 mg/m^2/Day | 9 | 29 | |
| other | Hypercholesterolemia | Metabolism and nutrition disorders | Bexarotene 150 mg/m^2/Day | 7 | 30 | |
| other | Hypercholesterolemia | Metabolism and nutrition disorders | Bexarotene 300 mg/m^2/Day | 7 | 29 | |
| other | Skin exfoliation | Skin and subcutaneous tissue disorders | Bexarotene 150 mg/m^2/Day | 5 | 30 | |
| other | Skin exfoliation | Skin and subcutaneous tissue disorders | Bexarotene 300 mg/m^2/Day | 5 | 29 |
1 to 10 of 116Source ClinicalTrials.gov
See all 116 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bexarotene 150 mg/m^2/Day | ||
| Total, all-cause mortality | Bexarotene 300 mg/m^2/Day | ||
| Total, other adverse events | Bexarotene 150 mg/m^2/Day | 21 | 30 |
| Total, other adverse events | Bexarotene 300 mg/m^2/Day | 21 | 29 |
| Total, serious adverse events | Bexarotene 150 mg/m^2/Day | 11 | 30 |
| Total, serious adverse events | Bexarotene 300 mg/m^2/Day | 13 | 29 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Bexarotene 150 mg/m^2/Day vs Bexarotene 300 mg/m^2/Day: serious adverse events |
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/NCT01007448
GET https://conductscience.org/api/trials/v1/NCT01007448/results?page=2