WithdrawnPhase 1/2

HDM201 Added to CT in R/R or Newly Diagnosed AML

Stopped: It was determined that the study design may not be optimal given the changing AML treatment landscape.

0Started 2019-11-15

Plain-language summary

This is a multi-center open-label Phase I/II study investigating orally administered HDM201 in combination with chemotherapy in two populations: subjects with first line AML or subjects with relapsed/refractory AML. This study is conducted in three parts: dose escalation, dose expansion and DDI study.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: All Subjects * Signed informed consent must be obtained prior to participation in the study * Age ≥18 * Diagnosis of AML based on WHO 2016 classification. Patients with APL (acute promyelocytic leukemia) with PML-RARA are not eligible. * Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) that is 0 - 2. * Adequate organ functions * Left ventricular ejection fraction \> 45% For 1L AML population: * For Part 1 or Part 2 Expansion Cohorts 1 or 2: subjects with de novo AML suitable for induction treatment with cytarabine and anthracyclines as per investigator judgement * For Part 2 Expansion Cohort 2: documented presence of FLT3 mutation (ITD or TKD ) and suitable for midostaurin treatment as per investigator judgement. * For Part 2 Expansion Cohort 3: Subjects with secondary AML (e.g. AML-MRC , secondary to myelodysplasia/MDS or therapy-related AML). Prior use of hypomethylating agents or other therapies with curative intent for treatment previous hematological malignancies or therapy-related AML is allowed. Subjects suitable for induction treatment with liposomal cytarabine/daunorubicin as per investigator judgement. For R/R AML population: * All Parts: Diagnosis of relapsed or refractory AML and suitable for treatment with IDAC as per investigator judgement. * For Part 3 only: willingness and suitability to participate in DDI Cohort 1 or 2. Exclusion Criteria: * Prior exposure to MDM2 and MDM4 inhibitor (e.g. idasanutlin) * Known sympt…

What they're measuring

Part 1 - Incidence of dose limiting toxicity (DLT)

Timeframe: first day of study treatment to 3 months after start of study treatment

Part 1 - Time to DLT

Timeframe: first day of study treatment to 3 months after start of study treatment

Part 1 - Incidence and severity of Adverse Events (AEs)

Timeframe: first day of study treatment to 3 months after start of study treatment

Part 2 - Incidence and severity of AEs/serious adverse events (SAEs)

Timeframe: first day of study treatment until 8.5 months after start of study treatment

Part 2 - Percentage of participants with complete remission (CR)/CR with incomplete recovery (CRi) with adequate blood count recovery (ABCR)

Timeframe: first day of study treatment until 4.5 months after start of study treatment

Part 2 - Incidence and severity of abnormal laboratory values

Timeframe: first day of study treatment until 8.5 months after start of study treatment

Part 2 - Incidence and severity of abnormal electrocardiogram (ECG) results

Timeframe: first day of study treatment until 8.5 months after start of study treatment

Trial details

NCT IDNCT03760445

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-22

View on ClinicalTrials.gov More Leukemia, Myeloid, Acute trials