Ignite Creation Date:
2024-05-06 @ 12:39 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01624766
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2012-06-19
Brief Title:
Everolimus and Anakinra or Denosumab in Treating Participants With Relapsed or Refractory Advanced Cancers
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 arent 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2011-1043 | OTHER | M D Anderson Cancer Center | None |
| NCI-2018-01842 | REGISTRY | None | None |