Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Quisinostat · 1 trial · 1 indication
The RR is defined as the number of participants who will achieve a complete response (CR) or partial response (PR). mSWAT criteria is used to evaluate the skin tumor burden. The investigator will determine the percentage of total body surface area (TBSA) affected by patches, plaques or tumors in 12 body regions, using the participant's palm and fingers representing 1% of TBSA. CR is defined as 100% clearance of skin lesions and PR is defined as 50% to 99 % clearance of skin lesions from baseline without occurrence of a new tumor.
| Arm | Type | Description |
|---|---|---|
| Quisinostat | EXPERIMENTAL | Participants will receive quisinostat 12 mg capsule orally (by mouth) on Days 1, 3, and 5 of each week in a 21-day treatment cycle, until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice). |
| Name | Type | Description |
|---|---|---|
| Quisinostat, 12 mg | DRUG | Participants will receive quisinostat 12 mg capsule orally (by mouth) on Days 1, 3, and 5 of each week in a 21-day treatment cycle, until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice). |
Inclusion Criteria: * Histopathologically confirmed cutaneous T-cell lymphoma (CTCL), either mycosis fungoides or sezary syndrome Stage Ib-IVa * Relapsed or refractory (unresponsive) disease following at least 1 prior systemic therapy for CTCL, except psoralen and long-wave ultraviolet radiation (i...
Quisinostat is an investigational small molecule being studied for the treatment of cutaneous T-cell lymphoma, a type of lymphoma that affects the skin. It has been evaluated in patients with previously treated Stage Ib to IVa cutaneous T-cell lymphoma. Quisinostat is not yet approved for any indication and remains in clinical development.
Quisinostat targets histone deacetylases, specifically HDAC1, HDAC2, HDAC3, HDAC5, HDAC6, and HDAC7. It acts as an HDAC inhibitor. By inhibiting these enzymes, quisinostat alters gene expression and is being investigated for its activity in cutaneous T-cell lymphoma.
Quisinostat is being developed by Johnson & Johnson, which trades under the ticker JNJ. The company sponsored the clinical trial evaluating the drug in cutaneous T-cell lymphoma.
Quisinostat is in Phase 2 clinical development. It has completed a Phase 2 trial in cutaneous T-cell lymphoma. The drug is investigational and has not been approved by the FDA or any regulatory agency for any indication.
Quisinostat has been studied in one completed Phase 2 trial, NCT01486277, titled A Study of the Histone Deacetylase Inhibitor (HDACi) Quisinostat (JNJ-26481585) in Patients With Previously Treated Stage Ib-IVa Cutaneous T-cell Lymphoma. The trial enrolled 26 patients across the United States, France, Germany, Portugal, Spain, and the United Kingdom.