| TITRE |
(EN) A Phase 1, Open-Label, Multicenter Study of INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms |
| PROTOCOLE ID |
INCA 33989-101 |
| CLINICAL TRIAL.gov ID |
NCT05936359 |
| TYPE(S) DE CANCER |
NMP : Vaquez , Thrombocythémie essentielle, Métaplasie myéloide |
| PHASE |
Phase I |
| TYPE D'ÉTUDE |
|
| INSTITUTION |
HOPITAL MAISONNEUVE-ROSEMONT
5415 boul. de l'Assomption
(514) 252-3400
|
| VILLE |
Montréal
|
| INVESTIGATEUR(RICE) PRINCIPAL(E) |
Natasha Szuber
|
| COORDONATEUR(RICE) |
Julie Trinh Lu
jtlu.hmr@ssss.gouv.qc.ca
514-252-3400 poste 3336
|
| STATUT |
Actif en recrutement
|
| CRITÈRES D'ÉLIGIBILITÉ |
(EN)
- 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 and ET as defined in the protocol.
|
| CRITÈRES D'EXCLUSION |
(EN)
- Presence of any hematological malignancy other than ET, PMF, or post-ET MF.
- Active invasive malignancy over the previous 2 years.
- Active HBV/HCV, HIV.
- History of clinically significant or uncontrolled cardiac disease.
- Has undergone any prior allogenic or autologous stem-cell transplantation or such transplantation is planned.
- Laboratory values outside the Protocol-defined ranges.
- 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.
- Prior history of major bleeding, or thrombosis within the last 3 months prior to study enrollment.
- 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.
- For TGBs only: Undergoing treatment with a potent/strong inhibitor or inducer of CYP 3A4/5 within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment, or expected to receive such treatment during the study.
|
