A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Com… (NCT04256317) | Clinical Trial Compass
RecruitingPhase 2/3
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
United States316 participantsStarted 2020-05-21
Plain-language summary
Study ASTX030-01 is a multi-phase study comprising of Phases 1-3 Monotherapy arms, and Phase 1 and Phase 2 Combination Therapy arms. Phase 1 Monotherapy consists of an open-label Dose Escalation Stage (Stage A) using multiple cohorts at escalating dose levels of oral cedazuridine and azacitidine (only one study drug will be escalated at a time) followed by a Dose Expansion Stage (Stage B). Phase 2 Monotherapy is a randomized, open-label, crossover study to compare oral ASTX030 to subcutaneous (SC) azacitidine. Phase 3 Monotherapy is a randomized open-label crossover study comparing the final fixed dose of oral ASTX030 to SC azacitidine. Phase 1 Combination Therapy is an open-label, multicenter, randomized, exploratory study comparing ASTX030 and SC azacitidine in combination with venetoclax in participants with treatment-naïve AML. Phase 2 Combination Therapy is an open-label, single arm, study evaluating the efficacy, safety, pharmacokinetics (PK), and drug interactions of ASTX030 in combination with venetoclax in participants with treatment-naïve AML.
The duration of this multi-phase study is approximately 8 years.
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
✓. Has confirmed MDS or CMML and is a candidate to receive and benefit from single agent azacitidine as applicable according to local country approvals and/or local institution standard practice:
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
✓. Participants with adequate organ function.
✓. For participants with prior allogeneic stem cell transplant, no evidence of graft-versus-host disease (GVHD).
✓. Participants with no major surgery within 3 weeks before first study treatment.
✓. Participants with no cytotoxic chemotherapy (excluding hydroxyurea) within 4 weeks before first study treatment.
✓. Is able to swallow the number of tablets/capsules required for the treatment assignment within a 10-minute period and tolerate 4 hours of fasting.
✓. Participants with projected life expectancy of at least 12 weeks.
Exclusion criteria
✕
What they're measuring
1
Phase 1, 2 and 3 Monotherapy: Total Cycle Area Under the Curve (AUC) From 0 to 24 Hours (AUC0-24) Exposures
Timeframe: Predose and at multiple timepoints post-dose up to 24 hours
2
Phase 1 Combination Therapy: Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 24 months
3
Phase 1 and 2 Combination Therapy: Complete Response (CR) Rate as Assessed by the Investigator
Timeframe: Up to 36 months
4
Phase 1 Combination Therapy: AUC0-24 of Venetoclax With ASTX030
Timeframe: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 7 (with ASTX030] of Cycle 1
5
Phase 1 Combination Therapy: AUC0-24 of Venetoclax Without ASTX030
Timeframe: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 14 (without ASTX030) of Cycle 1
6
Phase 1 Combination Therapy: Maximum Plasma Concentration (Cmax) of Venetoclax With ASTX030
Timeframe: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 7 (with ASTX030] of Cycle 1
7
Phase 1 Combination Therapy: Cmax of Venetoclax Without ASTX030
Timeframe: Pre-dose and at multiple timepoints post-dose up to 24 hours on Day 14 (without ASTX030) of Cycle 1
. Has an active uncontrolled gastric or duodenal ulcer.
✕. Has poor medical risk because of other conditions.
✕. Has known human immunodeficiency virus (HIV) infection.
✕. Is known to be positive for Hepatitis B or C infection.
✕. Has a life-threatening illness.
✕. Has a history of other malignancies prior to study entry, with the exception of adequately treated in situ carcinoma of the breast or cervix uteri; localized basal cell carcinoma or squamous cell carcinoma of the skin; previous malignancy confined and surgically resected or adequately treated and controlled with other modalities; and any early stage malignancy for which no definitive therapy is required.
✕. Participants with MDS/MPN including CMML who have clinical extramedullary disease including clinically palpable hepatomegaly or splenomegaly.
✕. Has previous treatment with more than 1 cycle of decitabine, azacitidine, or guadecitabine (Phases 2 and 3 only).