Expanded Access Program With Pevonedistat (Given With Azacitidine) for Adults With Higher-risk Myelodysplastic Syndromes
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|ClinicalTrials.gov Identifier: NCT04484363|
Expanded Access Status : No longer available
First Posted : July 23, 2020
Last Update Posted : September 30, 2022
Participants in the expanded access program are adults with higher-risk myelodysplastic syndromes who have no other treatment options available.
The main aim of this program is to allow participants to have access to pevonedistat before FDA approval.
This program will take place in the United States.
|Condition or disease||Intervention/treatment|
|Myelodysplastic Syndromes||Drug: Pevonedistat Drug: Azacitidine|
This is an expanded access program in which the drug being tested is called pevonedistat, which is used in combination with azcitidine. This study will provide expanded access of pevonedistat (in combination with azacitidine) for the first-line treatment to participants with HR-MDS and option of real world data (RWD) collection for the benefit of future participants.
All participants will receive azacitidine via intravenous or subcutaneous route in combination with pevonedistat intravenous infusion.
This multi-center trial will be conducted in the United States. Participant will continue treatment until benefit is no longer derived from the treatment (that is, until disease progression, or treatment is no longer tolerable), the benefit-risk no longer favors the individual, an appropriate alternative therapy becomes available, the participant chooses to discontinue the treatment, or pevonedistat becomes commercially available.
|Study Type :||Expanded Access|
|Expanded Access Type :||Intermediate-size Population|
|Official Title:||Expanded Access Program: Pevonedistat (in Combination With Azacitidine) for the First-line Treatment of Higher Risk Myelodysplastic Syndromes|
- Drug: Pevonedistat
Pevonedistat 20 milligram per square meter (mg/m^2), intravenous infusion, on Days 1, 3, and 5 of repeated 28-day cycles.
- Drug: Azacitidine
Azacitidine 75 mg/m^2, intravenous or subcutaneous infusion, on Days 1 to 5, Days 8 and 9 of repeated 28-day cycles or Days 1 through 7 of repeated 28-day cycles.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04484363
|Study Director:||Study Director||Takeda|