Clinical Trials

Gedatolisib (PKI-587) has been evaluated across numerous clinical trials spanning Phase I, Phase II, and Phase III for solid tumors and hematologic malignancies, including breast cancer subtypes (triple-negative, HER2-positive, and metastatic), endometrial cancer, non-small cell lung cancer, ovarian cancer, and acute myeloid leukemia. Sponsored by industry leaders such as Pfizer and Celcuity Inc. alongside academic institutions like the Dana-Farber Cancer Institute and Institut Curie, these studies encompass completed protocols, active recruiting and non-recruiting trials, and terminated early-phase evaluations.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06757634 RECRUITING
Breast Cancer
Celcuity Inc
 2025-07-24 PHASE3
NCT03675893 RECRUITING
Endometrial Cancer
Dana-Farber Cancer Institute
 2018-12-24 PHASE2
NCT06190899 RECRUITING
mCRPC (Metastatic Castration-resistant Prostate Cancer); Genital Diseases, Male; Urogenital Diseases, Male; Prostatic Disease; Prostatic Neoplasms, Castration-Resistant; Prostate Cancer
Celcuity Inc
 2024-01-01 PHASE1; PHASE2
NCT03065062 SUSPENDED
Lung Cancer Squamous Cell; Solid Tumors; Head & Neck Cancer; Pancreatic Cancer
Dana-Farber Cancer Institute
 2017-02-28 PHASE1
NCT05501886 ACTIVE_NOT_RECRUITING
Breast Cancer
Celcuity Inc
 2022-12-08 PHASE3
NCT03911973 ACTIVE_NOT_RECRUITING
TNBC - Triple-Negative Breast Cancer
Kari Wisinski
 2019-04-17 PHASE1; PHASE2
NCT02626507 UNKNOWN
Breast Cancer
Hoffman Oncology
 2016-01 PHASE1
NCT02684032 COMPLETED
Breast Cancer
Celcuity Inc
 2016-06-14 PHASE1
NCT03698383 UNKNOWN
HER2-positive Breast Cancer; Metastatic Breast Cancer
Korean Cancer Study Group
 2019-12-03 PHASE2
NCT03243331 COMPLETED
Triple Negative Breast Cancer; Metastatic Breast Cancer
Kathy Miller
 2018-01-19 PHASE1
NCT01920061 COMPLETED
Neoplasm
Pfizer
 2013-09-10 PHASE1
NCT03400254 WITHDRAWN
Breast Cancer
Abramson Cancer Center at Penn Medicine
 2019-02-26 PHASE1; PHASE2
NCT02920450 TERMINATED
Non-Small Cell Lung Cancer
University of Florida
 2017-09-25 PHASE1; PHASE2
NCT02438761 TERMINATED
Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome; Acute Myeloid Leukemia, in Relapse; de Novo Acute Myeloid Leukemia at Diagnostic
Institut Curie
 2015-08-31 PHASE2
NCT02438761 Terminated
Therapy-related Acute Myeloid Leukemia and Myelodysplastic Syndrome|Acute Myeloid Leukemia in Relapse|de Novo Acute Myeloid Leukemia at Diagnostic
Institut Curie|Fondation ARC|National Cancer Institute France
 2015-08-31 Phase 2
NCT02069158 Completed
Breast Cancer|NSCLC|Ovary Cancer|Endometrial Cancer|Small Cell Lung Cancer (SCLC)|Head and Neck (HNSCC)
Cristiana Sessa|Oncology Institute of Southern Switzerland
 2014-04 Phase 1
NCT01420081 Terminated
Endometrial Neoplasms
Pfizer
 2012-01-19 Phase 2
NCT00940498 COMPLETED
Neoplasms
Pfizer
 2010-01 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-05-18)

Check the Gedatolisib (PKI-587) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Gedatolisib (PKI-587) is a potent dual kinase inhibitor that selectively binds to phosphoinositide 3-kinase (PI3K) isoforms and mammalian target of rapamycin (mTOR), thereby preventing downstream phosphorylation of key effectors such as Akt. This biochemical blockade suppresses hyperactive cell survival signaling and induces apoptosis in malignant cells, providing therapeutic efficacy in clinical conditions such as breast cancer, endometrial carcinoma, and acute myeloid leukemia.

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.