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NCT02632071

ACY-1215 + Nab-paclitaxel in Metastatic Breast Cancer

Completed Phase 1 Last updated 7 January 2021
What this trial tests

Phase 1 trial testing ACY-1215 in Metastatic Breast Cancer in 17 participants. Completed in 30 September 2020.

Timeline
1 March 2016
Primary endpoint
30 September 2020
30 September 2020

Quick facts

Lead sponsorColumbia University
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment17
Start date1 March 2016
Primary completion30 September 2020
Estimated completion30 September 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Columbia University

Who can join

18 and older, any sex, with Metastatic Breast Cancer or Breast Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a non-randomized phase 1 trial designed to determine the MTD and evaluate the safety and tolerability of ACY-1215 with nab-paclitaxel. Based on the activity profile of ACY-1215 in breast cancer, corresponding biomarker availability with the HDAC6 MR score, and its potential synergy with taxanes, these data support the rationale for testing the ability of ACY-1215 to improve the response rate for patients with metastatic breast cancer in combination with standard taxane chemotherapy.

Publications & conference data

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

  1. Off-target toxicity is a common mechanism of action of cancer drugs undergoing clinical trials.
    Lin A, Giuliano CJ, Palladino A, John KM, et al · · 2019 · cited 549× · PMID 31511426 · DOI 10.1126/scitranslmed.aaw8412
  2. Histone deacetylase 6 in cancer.
    Li T, Zhang C, Hassan S, Liu X, et al · · 2018 · cited 261× · PMID 30176876 · DOI 10.1186/s13045-018-0654-9
  3. Chemotherapy-induced peripheral neuropathy: where are we now?
    Colvin LA. · · 2019 · cited 230× · PMID 31008843 · DOI 10.1097/j.pain.0000000000001540
  4. An expanded universe of cancer targets.
    Hahn WC, Bader JS, Braun TP, Califano A, et al · · 2021 · cited 160× · PMID 33667368 · DOI 10.1016/j.cell.2021.02.020
  5. HDAC6 inhibition effectively reverses chemotherapy-induced peripheral neuropathy.
    Krukowski K, Ma J, Golonzhka O, Laumet GO, et al · · 2017 · cited 155× · PMID 28267067 · DOI 10.1097/j.pain.0000000000000893
  6. Beyond symptomatic relief for chemotherapy-induced peripheral neuropathy: Targeting the source.
    Ma J, Kavelaars A, Dougherty PM, Heijnen CJ. · · 2018 · cited 133× · PMID 29461625 · DOI 10.1002/cncr.31248
  7. Recent developments in epigenetic cancer therapeutics: clinical advancement and emerging trends.
    Nepali K, Liou JP. · · 2021 · cited 122× · PMID 33840388 · DOI 10.1186/s12929-021-00721-x
  8. Network-based assessment of HDAC6 activity predicts preclinical and clinical responses to the HDAC6 inhibitor ricolinostat in breast cancer.
    Zeleke TZ, Pan Q, Chiuzan C, Onishi M, et al · · 2023 · cited 65× · PMID 36585452 · DOI 10.1038/s43018-022-00489-5

Verify or expand the search:

Other trials of ACY-1215

Trials testing the same drug.

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Other Columbia University trials

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Data sources for this page

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