A Study to Evaluate INCA033989 Administered in Participants With Myeloproliferative Neoplasms
Purpose
This study is being conducted to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered in participants with myeloproliferative neoplasms.
Condition
- Myeloproliferative Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Life expectancy > 6 months. - Willingness to undergo a pretreatment and regular on-study BM biopsies and aspirates (as appropriate to disease). - Existing documentation from a qualified local laboratory of CALR exon-9 mutation. - Participants with MF or ET as defined in the protocol.
Exclusion Criteria
- Presence of any hematological malignancy other than ET, PMF, or post-ET MF. - Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment. - Participants with laboratory values exceeding the protocol defined thresholds. - Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned. - Active invasive malignancy over the previous 2 years. - History of clinically significant or uncontrolled cardiac disease. - Active HBV/HCV or known history of HIV. - Any prior chemotherapy, immunomodulatory drug therapy, immunosuppressive therapy, biological therapy, endocrine therapy, targeted therapy, antibody, or hypomethylating agent used to treat the participant's disease within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment. - Participants undergoing treatment with G-CSF, GM-CSF, or TPO-R agonists at any time within 4 weeks before the first dose of study treatment. Other protocol-defined Inclusion/Exclusion Criteria may apply.
Study Design
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part 1a Dose Escalation Cohort Disease Group A - with MF |
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with myelofibrosis (MF) will enroll in this group. |
|
|
Experimental Part 1a Dose Escalation Cohort Disease Group A - with ET |
INCA033989 will be administered at a protocol defined starting regimen in 28-day cycles to identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE[s]). Participants with essential thrombocythemia (ET) will enroll in this group. |
|
|
Experimental Part 1b: Dose Expansion - with MF |
INCA033989 will be administered at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) myelofibrosis MF will enroll in this group. |
|
|
Experimental Part 1b: Dose Expansion - with ET |
INCA033989 will be administered at the RDE(s) identified during Part 1a. Participants with treatment group A (TGA) essential thrombocythemia (ET) will enroll in this group. |
|
Recruiting Locations
The University of Kansas Cancer Center
Westwood, Kansas 66205
Westwood, Kansas 66205
More Details
- Status
- Recruiting
- Sponsor
- Incyte Corporation