Clinical Trials

Numerous clinical trials evaluate the efficacy and safety of ridaforolimus as monotherapy or in combination with chemotherapy or biologics across diverse oncological and cardiovascular conditions, including advanced solid tumors, non-small cell lung cancer, endometrial cancer, ovarian cancer, lymphoma, multiple myeloma, and coronary stenosis. Spanning Phase 1 through Phase 3 development, these studies are sponsored by pharmaceutical companies and academic institutions. The trials encompass various recruitment statuses, including completed, active, recruiting, suspended, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06410313 RECRUITING
Superficial Femoral Artery Stenosis; Popliteal Artery Stenosis
Medinol Ltd.
 2024-08-15
NCT06071702 SUSPENDED
Coronary Stenosis; Coronary Artery Disease
Medinol Ltd.
 2025-08-07
NCT05364697 ACTIVE_NOT_RECRUITING
Coronary Stenosis; Coronary Disease; Non-ST Elevated Myocardial Infarction; Cardiovascular Diseases
Medinol Ltd.
 2022-08-30
NCT03702608 COMPLETED
Coronary Stenosis
Medinol Ltd.
 2018-11-14
NCT02828917 COMPLETED
de Novo or Restenosis Lesions
Medinol Ltd.
 2017-01-16
NCT00836927 TERMINATED
Advanced Cancers
Merck Sharp & Dohme LLC
 2009-02-01 PHASE2
NCT02834806 COMPLETED
Stenosis
Medinol Ltd.
 2016-09
NCT01995487 COMPLETED
Coronary Artery Stenosis
Medinol Ltd.
 2014-01
NCT01256268 COMPLETED
Endometrial Cancer; Ovarian Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2011-06-13 PHASE1
NCT01995500 COMPLETED
Coronary Artery Stenosis
Medinol Ltd.
 2014-03-19 PHASE2
NCT01169532 COMPLETED
Lymphoma; Unspecified Adult Solid Tumor, Protocol Specific
Fox Chase Cancer Center
 2010-10 PHASE1
NCT01605396 COMPLETED
Breast Neoplasms
Merck Sharp & Dohme LLC
 2012-07-04 PHASE2
NCT01295632 COMPLETED
Advanced Cancer
Merck Sharp & Dohme LLC
 2011-02 PHASE1
NCT01234857 COMPLETED
Breast Cancer
Merck Sharp & Dohme LLC
 2010-09-17 PHASE2
NCT01431547 COMPLETED
Solid Tumors
Merck Sharp & Dohme LLC
 2012-02 PHASE1
NCT01431534 TERMINATED
Solid Tumors
Merck Sharp & Dohme LLC
 2012-01-30 PHASE1
NCT01243762 TERMINATED
Neoplasms Malignant
Merck Sharp & Dohme LLC
 2010-11-22 PHASE1
NCT01212627 TERMINATED
Non-Small Cell Lung Cancer
Angela Taber MD
 2010-09 PHASE1
NCT01220570 COMPLETED
Breast Cancer
Merck Sharp & Dohme LLC
 2010-09 PHASE1
NCT00818675 TERMINATED
Non-Small Cell Lung Cancer
Merck Sharp & Dohme LLC
 2009-03 PHASE2
NCT00770185 COMPLETED
Endometrial Cancer
NCIC Clinical Trials Group
 2008-11-13 PHASE2
NCT01431547 Completed
Solid Tumors
Merck Sharp & Dohme LLC
 2012-02 Phase 1
NCT01431534 Terminated
Solid Tumors
Merck Sharp & Dohme LLC
 2012-01-30 Phase 1
NCT01380184 COMPLETED
Cancer, Advanced
Merck Sharp & Dohme LLC
 2011-07-05 PHASE1
NCT01010672 COMPLETED
Sarcoma
Merck Sharp & Dohme LLC
 2009-11 PHASE2
NCT01296659 WITHDRAWN
Soft Tissue Sarcoma
The University of Texas Health Science Center at San Antonio
 2011-02 PHASE1
NCT01380184 Completed
Cancer Advanced
Merck Sharp & Dohme LLC
 2011-07-05 Phase 1
NCT00777959 COMPLETED
Prostate Cancer
Merck Sharp & Dohme LLC
 2008-10 PHASE2
NCT00739830 COMPLETED
Endometrial Cancer
Merck Sharp & Dohme LLC
 2008-08 PHASE2
NCT01295632 Completed
Advanced Cancer
Merck Sharp & Dohme LLC
 2011-02 Phase 1
NCT00736970 COMPLETED
Breast Cancer; Breast Neoplasms
Merck Sharp & Dohme LLC
 2008-07 PHASE2
NCT00730379 COMPLETED
Neoplasms
Merck Sharp & Dohme LLC
 2008-07 PHASE1
NCT00538239 COMPLETED
Metastatic Soft-Tissue Sarcomas; Metastatic Bone Sarcomas
Merck Sharp & Dohme LLC
 2007-10 PHASE3
NCT01071304 COMPLETED
Relapsed or Refractory Advanced Cancer
Merck Sharp & Dohme LLC
 2010-03 PHASE1
NCT01212627 Terminated
Non-Small Cell Lung Cancer
Angela Taber MD|Rhode Island Hospital|The Miriam Hospital|Memorial Hospital of Rhode Island|Roger Williams Medical Center|Brown University
 2010-09 Phase 1
NCT00704054 COMPLETED
Solid Tumors
Merck Sharp & Dohme LLC
 2008-01 PHASE1
NCT01043887 COMPLETED
Healthy Volunteers; Hepatic Insufficiency
Merck Sharp & Dohme LLC
 2010-01 PHASE1
NCT00781846 COMPLETED
Solid Tumor
Merck Sharp & Dohme LLC
 2008-10 PHASE1
NCT00874731 COMPLETED
Metastatic or Locally Advanced Cancer
Merck Sharp & Dohme LLC
 2009-04-28 PHASE1
NCT00694083 COMPLETED
Neoplasm
Merck Sharp & Dohme LLC
 2008-06-10 PHASE1
NCT00112372 COMPLETED
Cancer
Merck Sharp & Dohme LLC
 2005-05 PHASE1
NCT00093080 COMPLETED
Leiomyosarcoma; Liposarcoma; Osteosarcoma; Sarcoma, Soft Tissue; Metastases
Merck Sharp & Dohme LLC
 2004-10 PHASE2
NCT00288431 COMPLETED
Cancer; Sarcoma
Merck Sharp & Dohme LLC
 2006-02 PHASE1
NCT00122343 COMPLETED
Endometrial Cancer
Merck Sharp & Dohme LLC
 2005-08 PHASE2
NCT00110188 COMPLETED
Prostate Cancer
Merck Sharp & Dohme LLC
 2005-05 PHASE2
NCT00086125 COMPLETED
Hematologic Malignancies; Leukemia; Myelodysplastic Syndromes; Myeloid Metaplasia; Lymphoma
Merck Sharp & Dohme LLC
 2004-06 PHASE2
NCT00060645 COMPLETED
Tumors; Lymphoma; Multiple Myeloma
Merck Sharp & Dohme LLC
 2003-05 PHASE1
NCT00060632 COMPLETED
Tumors; Lymphoma; Multiple Myeloma
Merck Sharp & Dohme LLC
 2003-04 PHASE1

(data from https://clinicaltrials.gov, updated on 2025-09-22)

Check the Ridaforolimus (Deforolimus, MK-8669) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ridaforolimus binds to FK506-binding protein 12 (FKBP12) to form a complex that selectively inhibits the mammalian target of rapamycin (mTOR) signaling pathway, blocking downstream kinase cascade activation involved in protein synthesis and cellular metabolism. This inhibition induces a nutrient-starvation phenotype that suppresses cellular proliferation, survival, and angiogenesis, ultimately impeding disease progression in clinical settings such as advanced solid tumors, endometrial cancer, and non-small cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.