NCT01624766

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

A Phase I Trial of Anakinra (IL-1 Receptor Antagonist) or Denosumab (Anti-RANKL Monoclonal Antibody) in Combination With Everolimus (mTOR Inhibitor) in Patients With Advanced Malignancies

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of anakinra or denosumab in combination with everolimus in patients with advanced cancers who progressed on standard therapy. SECONDARY OBJECTIVES: I. Preliminary assessment of antitumor efficacy of anakinra or denosumab in combination with everolimus in patients with advanced cancers. II. Assessment of the pharmacokinetic (PK) profile of anakinra or denosumab in combination with everolimus. III. Preliminary assessment of biomarkers. OUTLINE: This is a dose-escalation study of everolimus. Participants are assigned to 1 of 2 arms. ARM I: Participants receive everolimus orally (PO) daily and anakinra subcutaneously (SC) daily on days 1-28. Treatment repeats every 28 days in absence of disease progression or unacceptable toxicity. ARM II: Participants receive everolimus PO daily on days 1-28 and denosumab SC on day 1. Treatment repeats every 28 days in absence of disease progression or unacceptable toxicity. After completion of study treatment, participants are followed up at 30 days.

Conditions

• Advanced Malignant Neoplasm
• Metastatic Malignant Neoplasm
• Recurrent Malignant Neoplasm
• Refractory Malignant Neoplasm

Interventions

Type	Name	Description
BIOLOGICAL	Anakinra	Given SC
BIOLOGICAL	Denosumab	Given SC
DRUG	Everolimus	Given PO

Timeline

• Start date: 2012-06-19
• Primary completion: 2021-02-24
• Completion: 2021-02-24
• First posted: 2012-06-21
• Last updated: 2021-02-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study