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Study of BGB-11417 in Patients with Myeloid Malignancies
EU CTIS ID: 2023-508881-14-00
What this study is testing
Part 1 (dose regimen finding) and Part 2 (safety expansion) To determine the safety and tolerability of BGB-11417 in combination with azacitidine in patients with myeloid malignancies To select the dose regimens of BGB-11417 in combination with azacitidine to be evaluated in Part 2 (in Part 1 only) To determine the recommended Phase 2 dose (RP2D) of BGB-11417 in combination with azacitidine to be evaluated in Part 3 Part 3 (efficacy expansion) To evaluate the antileukemic activity of BGB-11417 in combination with azacitidine as measured by response rates To evaluate the effect of posaconazole on the pharmacokinetics of BGB-11417 when coadministered in a drug-drug interaction (DDI) cohort (Note: the DDI evaluation with posaconazole will not be conducted in Europe) For monotherapy: to determine the safety and tolerability of BGB-11417 monotherapy in patients with R/R AML, MDS and MDS/MPN
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Confirmed diagnosis of one of the following by 2016 World Health Organization criteria: • acute myeloid leukemia (AML), nonacute promyelocytic leukemia; • myelodysplastic syndrome (MDS); or • myelodysplastic syndrome/myeloproliferative neoplasms (MDS/MPN)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Adequate organ function defined as: • Creatinine clearance ≥ 50 milliliters/minute (mL/min) (or between 30 and 49 mL/min in unfit AML cohort) • Adequate liver function
- Life expectancy of > 12 weeks.
- Ability to comply with the requirements of the study.
- Note: other protocol-defined inclusion criteria may apply.
You likely can't join if
- A diagnosis of acute promyelocytic leukemia.
- Prior malignancy within the past 2 years, except for curatively treated localized skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score ≤ 6 prostate cancer.
- Antecedent MPN including myelofibrosis, essential thrombocytosis, polycythemia vera, or chronic myelogenous leukemia with or without BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
- Prior therapy with a B-cell lymphoma-2 inhibitor or azacitidine except for participants who meet HMA-failure critera.
- Known central nervous system involvement by leukemia.
- Note: other protocol-defined exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it's taking place
- China
- Korea, Republic of
- Australia
- United States
- New Zealand
- United Kingdom
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include China; Korea, Republic of; Australia; United States; New Zealand; United Kingdom. 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 EU CTIS; the study team decides eligibility.