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-IVa cutaneous T-cell lymphoma.
Quisinostat is being developed by Johnson & Johnson, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ.
Quisinostat is in Phase 2 clinical development. It has completed a Phase 2 trial in patients with previously treated Stage Ib-IVa cutaneous T-cell lymphoma. It is not approved and remains investigational.
Quisinostat has been studied in one completed Phase 2 clinical trial, identified as NCT01486277. This trial enrolled 26 patients with cutaneous T-cell lymphoma and was conducted in the United States, France, Germany, Portugal, Spain, and the United Kingdom.
Quisinostat is a histone deacetylase inhibitor, also known as an HDAC inhibitor. It works by inhibiting histone deacetylase enzymes, which play a role in gene expression and can affect cancer cell growth and survival.