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NCT02579824

Ascending Dose and Exploratory Expansion Study of DS-3032b, an Oral MDM2 Inhibitor, in Subjects With Relapsed and/or Refractory Multiple Myeloma

Terminated Phase 1 Last updated 15 November 2019
What this trial tests

Phase 1 trial testing DS-3032b in Myeloma in 14 participants. Terminated before completion.

Timeline
30 August 2016
Primary endpoint
7 November 2019
7 November 2019

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment14
Start date30 August 2016
Primary completion7 November 2019
Estimated completion7 November 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

M.D. Anderson Cancer Center — full company profile →

Who can join

18 and older, any sex, with Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a 2 part study: Part 1 (dose escalation) and Part 2 (dose expansion). The goal of Part 1 of this clinical research study is to find the highest tolerable dose of DS-3032b that can be given to patients with multiple myeloma (MM) that is relapsed (has come back) and/or refractory (has not responded to treatment). The goal of Part 2 of this clinical research study is to continue to study the safety of the highest tolerable dose found in Part 1 of the study.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Targeting p53 pathways: mechanisms, structures, and advances in therapy.
    Wang H, Guo M, Wei H, Chen Y. · · 2023 · cited 580× · PMID 36859359 · DOI 10.1038/s41392-023-01347-1
  2. Ubiquitination and deubiquitination in cancer: from mechanisms to novel therapeutic approaches.
    Liu F, Chen J, Li K, Li H, et al · · 2024 · cited 195× · PMID 39048965 · DOI 10.1186/s12943-024-02046-3
  3. MDM2/X inhibitors under clinical evaluation: perspectives for the management of hematological malignancies and pediatric cancer.
    Tisato V, Voltan R, Gonelli A, Secchiero P, et al · · 2017 · cited 191× · PMID 28673313 · DOI 10.1186/s13045-017-0500-5
  4. Targeting p53-MDM2 interaction by small-molecule inhibitors: learning from MDM2 inhibitors in clinical trials.
    Zhu H, Gao H, Ji Y, Zhou Q, et al · · 2022 · cited 141× · PMID 35831864 · DOI 10.1186/s13045-022-01314-3
  5. Inhibition of p53 inhibitors: progress, challenges and perspectives.
    Sanz G, Singh M, Peuget S, Selivanova G. · · 2019 · cited 106× · PMID 31310659 · DOI 10.1093/jmcb/mjz075
  6. Small-molecule MDM2/X inhibitors and PROTAC degraders for cancer therapy: advances and perspectives.
    Fang Y, Liao G, Yu B. · · 2020 · cited 80× · PMID 32874827 · DOI 10.1016/j.apsb.2020.01.003
  7. Therapeutic Approaches Targeting Nucleolus in Cancer.
    Carotenuto P, Pecoraro A, Palma G, Russo G, et al · · 2019 · cited 64× · PMID 31527430 · DOI 10.3390/cells8091090
  8. Reactivating TP53 signaling by the novel MDM2 inhibitor DS-3032b as a therapeutic option for high-risk neuroblastoma.
    Arnhold V, Schmelz K, Proba J, Winkler A, et al · · 2018 · cited 64× · PMID 29416773 · DOI 10.18632/oncotarget.23409

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Other recruiting trials for Myeloma

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02579824.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing