A Phase 4 interventional study of Bexarotene in Refractory Cutaneous T-cell Lymphoma, sponsored by Bausch Health Americas, Inc.. Completed at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-12.
Sponsored by Bausch Health Americas, Inc. · Phase 4, Interventional, and Treatment
This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy, tolerability, and safety of 2 initial dose levels of bexarotene capsules in participants with refractory CTCL.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 59 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.
Browse Lymphoma studies →Bausch Health Americas, Inc. is the lead sponsor of 209 studies on the registry; 9 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 16 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Prior therapy for the treatment of CTCL:
Topical retinoids, nitrogen mustard, carmustine (BCNU), imiquimod, or other antipruritic medication within 2 weeks of study entry.
If antipruritic medication cannot be avoided, antihistamine or antipruritic agents must be administered using a stable dose regimen for at least 1 week prior to initiation of study drug treatment and throughout the study, unless it is determined that a discontinuation or reduction in dose is indicated. Prior to the enrollment of any participant who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the investigator must contact Eisai to discuss the need for such agent. Mineral oil, baby oil, and simple moisturizing lotions may be used as emollients. Low- to mid- potency topical corticosteroids are allowed only for participants with erythroderma (Stage III/IV CTCL) using a stable dose regimen for at least 4 weeks prior to study entry. High potency topical corticosteroids and tar baths are NOT permitted.
NOTE: Prior to the enrollment of any participant who will be taking systemic or dermatologically-applied antihistamine or anti-pruritic agent, the Investigator must contact the Sponsor to discuss the need for such agent.
Participants will receive bexarotene 150 mg/m\^2/day once daily for 24 weeks.
Drug: Bexarotene
Participants will receive bexarotene 300 mg/m\^2/day once daily for 24 weeks.
Drug: Bexarotene
Soft gelatin capsules to be taken orally with at least 6 ounces of water or other fluid either with or immediately following the evening meal (a moderate or full meal) or a nutritionally defined liquid food.
Also known as: Targretin®
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
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).
Time frame: Baseline up to Week 24
Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined by Physician's Global Assessment (PGA) of Clinical Condition
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.
Time frame: Baseline up to Week 24
Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined Percent Body Surface Area (BSA) Involvement
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%.
Time frame: Baseline up to Week 24
Duration of Tumor Response (CR, CCR, or PR) as Determined by Investigator's CA of Index Lesion Disease Severity
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).
Time frame: Baseline up to Week 24
Duration of Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition
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).
Time frame: Baseline up to Week 24
Duration of Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement
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%.
Time frame: Baseline up to Week 24
Time to Tumor Response (CR, CCR, or PR) as Determined by CA of Index Lesion Disease Severity
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).
Time frame: Baseline up to Week 24
Time to Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition
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).
Time frame: Baseline up to Week 24
Time to Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement
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%.
Time frame: Baseline up to Week 24
Time to Tumor Progression as Determined by CA of Index Lesion Disease Severity
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.
Time frame: Baseline up to Week 24
Time to Tumor Progression as Determined by PGA of Clinical Condition
Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. 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. 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.
Time frame: Baseline up to Week 24
Time to Tumor Progression as Determined by Percent BSA Involvement
Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. 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. PD=an increase from Baseline in percent BSA of at least 25%.
Time frame: Baseline up to Week 24
| Milestone | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Started | 30 | 29 |
| Full analysis population | 30 | 29 |
| Safety population | 30 | 29 |
| Completed | 20 | 20 |
| Not completed | 10 | 9 |
| Withdrew: Continuing prohibited systemic drugs | 1 | 0 |
| Withdrew: Staph skin infection flare | 1 | 0 |
| Withdrew: Participant leaving the country | 1 | 0 |
| Withdrew: Participant given prohibited medication | 1 | 0 |
| Withdrew: Progressive disease | 1 | 2 |
| Withdrew: Lack of efficacy | 2 | 0 |
| Withdrew: Withdrawal by subject | 2 | 3 |
| Withdrew: Adverse event | 1 | 4 |
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).
| Participants | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| CR | 0 | 0 |
| CCR | 2 | 3 |
| PR | 5 | 7 |
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.
| Participants | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| CR | 0 | 0 |
| CCR | 1 | 3 |
| PR | 5 | 8 |
| SD | 23 | 16 |
| PD | 0 | 0 |
| Unknown | 1 | 2 |
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%.
| Participants | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| CR | 1 | 2 |
| CCR | 0 | 1 |
| PR | 6 | 7 |
| SD | 22 | 17 |
| PD | 0 | 0 |
| Unknown | 1 | 2 |
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).
| days | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Duration of Tumor Response (CR, CCR, or PR) as Determined by Investigator's CA of Index Lesion Disease Severity | 65.9 ± 41.86 | 83.7 ± 36.50 |
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).
| days | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Duration of Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | 111.5 ± 34.61 | 69.4 ± 38.93 |
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%.
| days | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Duration of Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | 99.4 ± 41.69 | 54.1 ± 42.18 |
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).
| days | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Time to Tumor Response (CR, CCR, or PR) as Determined by CA of Index Lesion Disease Severity | 99.9 ± 39.14 | 91.6 ± 37.20 |
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).
| days | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Time to Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition | 53.5 ± 23.32 | 103.5 ± 41.34 |
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%.
| days | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Time to Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement | 66.1 ± 36.97 | 117.0 ± 41.90 |
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.
| days | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Time to Tumor Progression as Determined by CA of Index Lesion Disease Severity | 203.0 ± NA | 77.5 ± 58.69 |
Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. 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. 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.
| days | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Time to Tumor Progression as Determined by PGA of Clinical Condition | — | 115.5 ± 4.95 |
Defined as time interval from first day of bexarotene treatment to time of first observation when participant met criteria for PD. 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. PD=an increase from Baseline in percent BSA of at least 25%.
| days | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| Time to Tumor Progression as Determined by Percent BSA Involvement | 86.0 ± 1.41 | 88.0 ± 43.84 |
Collected over Baseline up to Week 28. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Bexarotene 150 mg/m^2/Day | — | 11/30 (36.7%) | 21/30 (70%) |
| Bexarotene 300 mg/m^2/Day | — | 13/29 (44.8%) | 21/29 (72.4%) |
| Event | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| HypertriglyceridaemiaMetabolism and nutrition disorders | 2/30 | 9/29 |
| Bone marrow failureBlood and lymphatic system disorders | 1/30 | 3/29 |
| NeutropeniaBlood and lymphatic system disorders | 0/30 | 3/29 |
| PneumoniaInfections and infestations | 0/30 | 2/29 |
| Abdominal pain upperGastrointestinal disorders | 0/30 | 1/29 |
| HypercholesterolaemiaMetabolism and nutrition disorders | 0/30 | 1/29 |
| AnaemiaBlood and lymphatic system disorders | 0/30 | 1/29 |
| Mycosis fungoidesNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/30 | 1/29 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 0/30 | 1/29 |
| Blood triglycerides increasedInvestigations | 1/30 | 0/29 |
| Event | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day |
|---|---|---|
| HypertriglyceridemiaMetabolism and nutrition disorders | 17/30 | 14/29 |
| HypothyroidismEndocrine disorders | 12/30 | 15/29 |
| HeadacheNervous system disorders | 7/30 | 9/29 |
| HypercholesterolemiaMetabolism and nutrition disorders | 7/30 | 7/29 |
| Skin exfoliationSkin and subcutaneous tissue disorders | 5/30 | 5/29 |
| NeutropeniaBlood and lymphatic system disorders | 2/30 | 5/29 |
| Blood triglycerides increasedInvestigations | 3/30 | 4/29 |
| Thyroxine free decreasedInvestigations | 4/30 | 4/29 |
| Alanine aminotransferase increasedInvestigations | 3/30 | 4/29 |
| Oedema peripheralGeneral disorders | 2/30 | 4/29 |
Participants who received at least 1 dose of study drug (Full Analysis Population).
| Age, Continuous(years) | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day | Total |
|---|---|---|---|
| Mean | 60.2 ± 14.80 | 61.0 ± 13.94 | 60.6 ± 14.26 |
| Sex: Female, Male(Participants) | Bexarotene 150 mg/m^2/Day | Bexarotene 300 mg/m^2/Day | Total |
|---|---|---|---|
| Female | 13 | 13 | 26 |
| Male | 17 | 16 | 33 |
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Bausch Health Americas, Inc.