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New treatment option for Myeloproliferative Neoplasms
Official title A Study to Evaluate INCA033989 Administered as a Monotherapy or in Combination With Ruxolitinib in Participants With Myeloproliferative Neoplasms
ClinicalTrials.gov ID: NCT05936359
What this study is testing
What is INCA033989?
INCA033989 is an investigational medicine, being studied as a potential treatment for myeloproliferative neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is being conducted to evaluate the safety, tolerability, and dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) and/or recommended dose(s) for expansion (RDE) of INCA033989 administered as a monotherapy or in combination with ruxolitinib in participants with myeloproliferative neoplasms.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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 and ET as defined in the protocol.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Herston, Queensland, Australia
- Adelaide, South Australia, Australia
- Melbourne, Victoria, Australia
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Odense C, Denmark
- Roskilde, Denmark
- Vejle, Denmark
- Bordeaux, France
- Nîmes, France
- Paris, France
- Villejuif, France
- Aachen, Germany
- Halle, Germany
- Ulm, Germany
- Bologna, Italy
- Florence, Italy
- Milan, Italy
- Chiba-ken, Japan
- Kagoshima, Japan
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Herston, Queensland, Australia; Adelaide, South Australia, Australia; Melbourne, Victoria, Australia; Toronto, Ontario, Canada; Montreal, Quebec, Canada; Odense C, Denmark and 22 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.