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Phase 4 N=59 Randomized Treatment

Study Evaluating Two Dose Levels of Targretin Capsules in Participants With Refractory Cutaneous T-Cell Lymphoma (CTCL)

Refractory Cutaneous T-cell Lymphoma

Enrolled (actual)
59
Serious AEs
40.7%
Results posted
Nov 2019
Primary outcome: 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 — 0; 0; 2; 3 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Bexarotene (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Bausch Health Americas, Inc.
Primary completion
Feb 2014

Outcome Measures

OutcomeResultp-value
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
0; 0; 2; 3; 5; 7
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
0; 0; 1; 3; 5; 8
PRIMARY
Number of Participants With Tumor Response of CR, CCR, PR, SD, and PD as Determined Percent Body Surface Area (BSA) Involvement
1; 2; 0; 1; 6; 7
SECONDARY
Duration of Tumor Response (CR, CCR, or PR) as Determined by Investigator's CA of Index Lesion Disease Severity
65.9; 83.7
SECONDARY
Duration of Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition
111.5; 69.4
SECONDARY
Duration of Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement
99.4; 54.1
SECONDARY
Time to Tumor Response (CR, CCR, or PR) as Determined by CA of Index Lesion Disease Severity
99.9; 91.6
SECONDARY
Time to Tumor Response (CR, CCR, or PR) as Determined by PGA of Clinical Condition
53.5; 103.5
SECONDARY
Time to Tumor Response (CR, CCR, or PR) as Determined by Percent BSA Involvement
66.1; 117.0
SECONDARY
Time to Tumor Progression as Determined by CA of Index Lesion Disease Severity
203.0; 77.5
SECONDARY
Time to Tumor Progression as Determined by PGA of Clinical Condition
115.5
SECONDARY
Time to Tumor Progression as Determined by Percent BSA Involvement
86.0; 88.0

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • A CTCL without central nervous system (CNS) involvement, confirmed by biopsy to be histologically consistent with CTCL diagnosis by a dermatopathologist.
  • Refractory to at least 1 systemic therapy for CTCL. (Refractory is defined as resistance to therapy due either to lack of response of at least 50% improvement or progression of disease while still on therapy after an initial response.)
  • Systemic therapy for CTCL is indicated.
  • A Karnofsky performance score ≥60%.
  • Age ≥18 years.
  • Females of childbearing potential must have a negative serum beta human chorionic gonadotropin (ß-hCG) with a sensitivity of at least 50 milli-international units/liter (mIU/L) within 7 days prior to the initiation of treatment. Females of childbearing potential must have used simultaneously two highly effective methods of contraception (strongly recommended that 1 of the 2 forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or have a vasectomized partner) or use an intrauterine device or must have been sexually abstinent for at least four weeks prior to or at least 1 menstrual cycle prior to (whichever is longer) the negative pregnancy test through entry in the study. Sexual abstinence or effective contraception must be used for at least 1 month prior to the initiation of therapy, during therapy, and for at least 1 month following discontinuation of therapy. Perimenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
  • Male participants with female partners of childbearing potential must agree to sexual abstinence or to practice 2 reliable forms of effective contraception used simultaneously (strongly recommended that 1 of the 2 forms of contraception be non-hormonal such as condom plus spermicide, condom plus diaphragm with spermicide, or partner with tubal ligation) or partner may use an intrauterine device, during the entire period of bexarotene capsule treatment and for at least 1 month after treatment is discontinued. Male participants with female sexual partners who are pregnant, possibly pregnant or who could become pregnant during the study must agree to use condoms during sexual intercourse during the entire period of bexarotene capsule treatment and for at least 1 month after the last dose of bexarotene capsules.
  • Must be willing and able to give informed consent and complete and understand, either oral or written, study procedures and assessments.
  • Participant must be suitable for participation in the study in the Investigator's opinion.
  • Fasting serum triglyceride within normal limits (<150 mg/deciliter [dL]) prior to study entry.
  • Adequate renal function as evidenced by serum creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥40 milliliters (mL)/minute (min) as per the Cockroft and Gault formula.
  • Adequate hepatic function that is characterized by aspartate aminotransferase (SGOT [AST]), alanine aminotransferase (SGPT [ALT]), or serum bilirubin <2.5 times the upper limit of normal.
  • Adequate bone marrow function as evidenced by hemoglobin ≥8 grams (g)/dL, absolute neutrophil count (ANC) ≥1,000/milliliters cubed (mm^3), and platelets ≥50,000/mm^3.

Exclusion Criteria

  • Cutaneous T-cell lymphoma involving the central nervous system.
  • Participants with known Human Immunodeficiency Virus (HIV) infection and active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection (HBV/HCV or HIV testing is not required for the purpose of this study).
  • Participation in any other investigational drug study within 30 days of entry in this study.
  • Within 5 years after the onset of menopause.
  • Received systemic corticosteroids within 6 months of entry in the study.
  • Known hypersensitivity to bexarotene or other component of bexarotene capsules.
  • Pregnancy, intent to become pregnant, or breast-feeding.
  • Received gemfibrozil within 1 day of starting the study.
  • Prior the
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01007448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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