Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers
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|ClinicalTrials.gov Identifier: NCT01624766|
Recruitment Status : Active, not recruiting
First Posted : June 21, 2012
Last Update Posted : September 20, 2018
|Condition or disease||Intervention/treatment||Phase|
|Advanced Malignant Neoplasm Metastatic Malignant Neoplasm Recurrent Malignant Neoplasm Refractory Malignant Neoplasm||Biological: Anakinra Biological: Denosumab Drug: Everolimus||Phase 1|
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.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||147 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Actual Study Start Date :||June 19, 2012|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Experimental: Arm I (everolimus, anakinra)
Participants receive everolimus PO daily and anakinra SC daily on days 1-28. Treatment repeats every 28 days in absence of disease progression or unacceptable toxicity.
Experimental: Arm II (everolimus, denosumab)
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.
- Maximum tolerated dose (MTD) of everolimus [ Time Frame: At 28 days ]If more than 33% of patients enrolled at any particular dose level develop dose limiting toxicity (DLT), the treatment will continue at the dose level immediately below. If not more than 33% of the patients in the cohort develop DLT, this cohort will be considered the MTD. Only DLTs within course 1 (4 weeks) will be counted with respect to the dose-escalation algorithm.
- Incidence of adverse events [ Time Frame: Up to 30 days ]Describing the toxicity profile, descriptive statistics will be provided on the grade and type of toxicity by dose level.
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): NCT01624766
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Filip Janku||M.D. Anderson Cancer Center|