A Phase 3 Study of INCA033989 Versus Best Available Therapy in Participants With Essential Thrombocythemia
Purpose
This study is being conducted to evaluate INCA033989 versus best available therapy in participants with essential thrombocythemia and a CALR mutation previously treated with cytoreductive therapy.
Condition
- Essential Thrombocythemia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Confirmed diagnosis of high-risk ET. - Presence of mutCALR. - Prior treatment with at least 1 cytoreductive therapy.
Exclusion Criteria
- Presence of any hematologic malignancy other than ET. - Major bleeding or thrombosis within the last 3 months prior to study enrollment. - Any prior allogenic or autologous stem-cell transplantation. - Unresolved toxicity ≥ Grade 2 from previous therapy except for stable chronic toxicities (Grade 2) not expected to resolve, such as stable Grade 2 peripheral neuropathy. - Prior nonhematologic malignancy except for the following: Malignancy treated with curative intent and with no evidence of active disease for more than 2 years before screening. Adequately treated carcinoma in situ without current evidence of disease. Other protocol-defined Inclusion/Exclusion Criteria apply.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental INCA033989 |
Administered intravenous (IV) in accordance with the protocol-defined requirements. |
|
|
Experimental Best Available Therapy (BAT) |
Best Available Therapy (BAT) will be selected by the investigator. |
|
Recruiting Locations
Marin Cancer Care
Greenbrae, California 94904
Greenbrae, California 94904
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation