| Targretin® capsules are a member of the retinoid class of drugs that is associated with birth defects in humans. Targretin® capsules also caused birth defects when administered orally to pregnant rats. Targretin® capsules must not be administered to a pregnant woman. See CONTRAINDICATIONS. |
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TARGRETIN SUMMARY
Targretin® (bexarotene) capsules, 75 mg
Targretin® (bexarotene) is a member of a subclass of retinoids that selectively activate retinoid X receptors (RXRs). These retinoid receptors have biologic activity distinct from that of retinoic acid receptors (RARs). Each soft gelatin capsule for oral administration contains 75 mg of bexarotene.
Targretin® (bexarotene) capsules are indicated for the treatment of cutaneous manifestations of cutaneous T-cell lymphoma in patients who are refractory to at least one prior systemic therapy.
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NEWS HIGHLIGHTS
Published Studies Related to Targretin (Bexarotene)
Phase I/II randomized bilateral half-head comparison of topical bexarotene 1% gel for alopecia areata. [2009.10]
BACKGROUND: Alopecia areata, hair loss caused by perifollicular T-cell infiltrates, is refractory to therapy. Bexarotene, a retinoid X receptor is a selective retinoid, induces T-cell apoptosis. OBJECTIVE: We sought to determine the safety, including the dose-limiting toxicities with adverse events, and efficacy, ie, response rate, of bexarotene in alopecia areata... CONCLUSION: Topical bexarotene 1% application is well tolerated and possibly effective. A randomized placebo-controlled trial should be conducted.
Randomized phase III trial comparing bexarotene (L1069-49)/cisplatin/vinorelbine with cisplatin/vinorelbine in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT I. [2008.04.10]
PURPOSE: This study evaluated whether the combination of the synthetic rexinoid bexarotene with first-line cisplatin/vinorelbine therapy provides additional survival benefit in patients with advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: The addition of bexarotene to first-line chemotherapy did not increase survival in patients with advanced NSCLC. However, a subgroup (32%) of bexarotene-treated patients developing high-grade hypertriglyceridemia appeared to have better survival (12.3 months) than controls; thus triglyceride response may be a biomarker of survival benefit with bexarotene.
Phase III trial comparing carboplatin, paclitaxel, and bexarotene with carboplatin and paclitaxel in chemotherapy-naive patients with advanced or metastatic non-small-cell lung cancer: SPIRIT II. [2008.04.10]
PURPOSE: The purpose of this study was to determine whether addition of the synthetic rexinoid bexarotene (Targretin; Eisai Inc, Woodcliff Lake, NJ) to standard first-line carboplatin and paclitaxel therapy provides additional survival benefit in patients with advanced non-small-cell lung cancer (NSCLC)... CONCLUSION: Although the addition of bexarotene to chemotherapy did not improve survival in the overall study population, occurrence of high-grade hypertriglyceridemia in bexarotene-treated patients strongly correlated with increased survival, suggesting that bexarotene may benefit a segment of first-line NSCLC patients.
Phase II clinical trial of bexarotene gel 1% in psoriasis. [2007.05]
We report the results of a nonrandomized, open-label pilot trial investigating the safety, tolerability, and efficacy of bexarotene gel 1% in treating chronic mild to moderate plaque psoriasis. Twenty-four adults with mild to moderate stable plaque psoriasis involving 15% or less of their body surface were enrolled...
Phase II trial of bexarotene capsules in patients with advanced non-small-cell lung cancer after failure of two or more previous therapies. [2006.10.20]
PURPOSE: To evaluate the effect of bexarotene on survival in patients with relapsed non-small-cell lung cancer (NSCLC)... CONCLUSION: In the intent-to-treat population, bexarotene given as third or subsequent line of therapy for relapsed NSCLC did not achieve the intended median survival of 6 months. Survival may have been extended in patients who developed bexarotene-induced hypertriglyceremia and/or skin rash. It is important to confirm these observations in a randomized controlled trial.
Clinical Trials Related to Targretin (Bexarotene)
Intravenous (IV) Decitabine and Oral Bexarotene for Acute Myelogenous Leukemia (AML) [Recruiting]
The investigators are seeking to study the combination of decitabine and bexarotene. These
two agents have each shown efficacy in decreasing leukemic blast counts and restoring normal
hematopoiesis via different mechanisms of action and with non-overlapping side-effect
profiles. By combining these agents, the investigators hope to improve overall response
rates. The investigators further hope to improve platelet and neutrophil counts in an even
greater number of patients, thus treating two of the most important sources of morbidity and
mortality in this patient population.
Study Evaluating Two Dose Levels of Targretin Capsules in Patients With Refractory Cutaneous T-cell Lymphoma (CTCL) [Recruiting]
This is a multicenter, randomized, open-label, Phase IV study to assess the efficacy,
tolerability and safety of two initial dose levels of bexarotene capsules in patients with
refractory cutaneous T-cell lymphoma (CTCL).
Bexarotene Augmentation of Antipsychotic Treatment for Chronic Schizophrenia [Recruiting]
Background: Bexarotene (Targretin) is a synthetic retinoid mainly used for treatment of
patients suffer from oncological or dermatological diseases. The present study is based on:
evidence that retinoids are involved in neurodevelopment ("the retinoid dysregulation
hypothesis"); an assumption that the combined effect of antipsychotic agents and bexarotene
will have a beneficial effect on schizophrenia patients; and the positive findings from our
pilot open-label clinical trial (ClinicalTrials. gov Identifier: NCT00141947). However,
clinical efficacy of bexarotene should be investigated in a placebo-controlled trial.
Methods: In a 6-week, randomized, double-blind placebo-controlled trial Targretin (75
mg/day) or placebo capsules will be added to the stable ongoing antipsychotic treatment of
90 schizophrenia patients. Participants will be assessed at baseline and after 2, 4 and 6
weeks of treatment. A battery of research instruments will be used for assessment of
psychopathology, side effects, general functioning and quality of life. In addition,
cholesterol and triglyceride levels, liver and thyroid function tests and a blood cell count
will be monitored at baseline and during the study
Phase I Study of CS-7017 and Bexarotene [Recruiting]
This study is for patients with advanced solid tumors. The purpose of this study is to test
the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in
patients with advanced cancer. CS-7017 and Bexarotene both have many effects on cancer
cells, including stopping cancer cells from growing and dividing, and causing the cancer
cells to die. CS-7017 and Bexarotene work on cancer cells in a similar manner and both drugs
together may have an even greater effect against cancer cells, hopefully, increasing the
killing of cancer cells.
CS-7017 is an investigational or experimental anti-cancer agent that has not yet been
approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene
is an anti-cancer agent that has been approved by the FDA for patients with a specific type
of cancer, cutaneous T-cell lymphoma.
This study will help find out what effects the combination of drugs, CS-7017 and Bexarotene,
has on cancer. This research is being done because it is not known if CS-7017 is safe to be
given with Bexarotene.
Phase II Study of Bexarotene in Patients With Acute Myeloid Leukemia [Recruiting]
The purpose of this study is to evaluate the activity of bexarotene, a retinoic acid class
drug, in patients with Acute Myeloid Leukemia (AML) that has returned after or is resistant
to standard chemotherapy or are otherwise not eligible for conventional chemotherapy.
Retinoic acids are a class of drugs related to Vitamin A, and have a wide range of effects
within normal and malignant cells that affect cell growth and cell death.
Reports of Suspected Targretin (Bexarotene) Side Effects
Dehydration (7),
Lung Infection (3),
Anaemia (3),
Febrile Neutropenia (3),
Haematochezia (3),
Abdominal Pain (2),
Tinnitus (2),
Coagulopathy (2),
Deafness (2),
Cardiac Failure Congestive (2), more >>
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Page last updated: 2009-10-20
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