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NCT01624766

Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers

Completed Phase 1 Last updated 25 February 2021
What this trial tests

Phase 1 trial testing Anakinra in Advanced Malignant Neoplasm in 57 participants. Completed in 24 February 2021.

Timeline
19 June 2012
Primary endpoint
24 February 2021
24 February 2021

Quick facts

Lead sponsorM.D. Anderson Cancer Center
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment57
Start date19 June 2012
Primary completion24 February 2021
Estimated completion24 February 2021
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 Advanced Malignant Neoplasm or Metastatic Malignant Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial studies the side effects and best dose of everolimus when given together with anakinra or denosumab in treating participants with cancers that have spread to other places in the body and have come back or aren't responding to treatment. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Anakinra is designated to block a protein that is involved in tumor development, new blood vessels growing, and the spread of cancer. Monoclonal antibodies, such as denosumab, may interfere with the ability of tumor cells to grow and spread. Giving everolimus and anakinra or denosumab may work better in treating participants with advanced cancers.

Publications & conference data

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

  1. Targeting cytokine and chemokine signaling pathways for cancer therapy.
    Yi M, Li T, Niu M, Zhang H, et al · · 2024 · cited 264× · PMID 39034318 · DOI 10.1038/s41392-024-01868-3
  2. Roles of IL-1 in Cancer: From Tumor Progression to Resistance to Targeted Therapies.
    Gelfo V, Romaniello D, Mazzeschi M, Sgarzi M, et al · · 2020 · cited 135× · PMID 32825489 · DOI 10.3390/ijms21176009
  3. The Role of Interleukin-1 in the Pathogenesis of Cancer and its Potential as a Therapeutic Target in Clinical Practice.
    Litmanovich A, Khazim K, Cohen I. · · 2018 · cited 76× · PMID 32700032 · DOI 10.1007/s40487-018-0089-z
  4. Pro-Inflammatory Cytokines in the Formation of the Pre-Metastatic Niche.
    Li R, Wen A, Lin J. · · 2020 · cited 63× · PMID 33322216 · DOI 10.3390/cancers12123752
  5. Tumor-associated macrophage polarization in the inflammatory tumor microenvironment.
    Zou Z, Lin H, Li M, Lin B. · · 2023 · cited 57× · PMID 36816959 · DOI 10.3389/fonc.2023.1103149
  6. Targeting interleukin-1β and inflammation in lung cancer.
    Zhang J, Veeramachaneni N. · · 2022 · cited 56× · PMID 35086565 · DOI 10.1186/s40364-021-00341-5
  7. Involvement of inflammasomes in tumor microenvironment and tumor therapies.
    Zhang Z, Li X, Wang Y, Wei Y, et al · · 2023 · cited 55× · PMID 36932407 · DOI 10.1186/s13045-023-01407-7
  8. Metastasis-associated fibroblasts: an emerging target for metastatic cancer.
    Wang Z, Liu J, Huang H, Ye M, et al · · 2021 · cited 50× · PMID 34112258 · DOI 10.1186/s40364-021-00305-9

Verify or expand the search:

Other trials of Anakinra

Trials testing the same drug.

Other recruiting trials for Advanced Malignant Neoplasm

Currently open trials in the same condition.

Other M.D. Anderson Cancer Center trials

Trials by the same sponsor.

Verify against primary sources

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/NCT01624766.

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