Dactolisib (BEZ235) Clinical Trials

Size	Price	Qty
50mg	USD 147
1g	USD 970

Clinical Trials

Numerous clinical trials, ranging from Phase 1 to Phase 3, evaluate dactolisib across diverse oncology and respiratory indications, including metastatic breast cancer, acute lymphoblastic leukemia, castration-resistant prostate cancer, and symptomatic respiratory infections. Sponsored by academic and industry entities such as Novartis Pharmaceuticals, Restorbio Inc., Pfizer, and Goethe University, these protocols reflect varied recruitment outcomes, encompassing active, completed, terminated, and withdrawn studies.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04668352	COMPLETED	Respiratory Tract Infections	Restorbio Inc.	2019-04-15	PHASE3
NCT04139915	WITHDRAWN	Clinically Symptomatic Respiratory Illness	Restorbio Inc.	2019-10-21	PHASE3
NCT03373903	ACTIVE_NOT_RECRUITING	Respiratory Tract Infections	Restorbio Inc.	2017-11-15	PHASE2
NCT01756118	COMPLETED	Acute Lymphoblastic Leukemia; Leukemia, Myelocytic, Acute; Chronic Myelogenous Leukemia With Crisis of Blast Cells	Goethe University	2012-06	PHASE1
NCT01288092	WITHDRAWN	Metastatic Breast Cancer	Novartis Pharmaceuticals	2012-03	PHASE2
NCT01658436	COMPLETED	Pancreatic Neuroendocrine Tumors (pNET)	Novartis Pharmaceuticals	2012-11	PHASE2
NCT01634061	COMPLETED	Castration-resistant Prostate Cancer	Novartis Pharmaceuticals	2012-09	PHASE1
NCT01482156	COMPLETED	Advanced Solid Tumors; Metastatic Breast Cancer; Metastatic Renal Cell Carcinoma	Novartis Pharmaceuticals	2012-01	PHASE1
NCT01690871	WITHDRAWN	Malignant PEComa (Perivascular Epithelioid Cell Tumors)	Novartis Pharmaceuticals	2012-09	PHASE2
NCT01285466	COMPLETED	Metastatic or Locally Advanced Solid Tumors	Novartis Pharmaceuticals	2011-01	PHASE1
NCT01628913	TERMINATED	Pancreatic Neuroendocrine Tumors (pNET)	Novartis Pharmaceuticals	2012-10	PHASE2
NCT01290406	WITHDRAWN	Endometrial Cancer	Novartis Pharmaceuticals	2012-03	PHASE2
NCT01495247	TERMINATED	Inoperable Locally Advanced Breast Cancer; Metastatic Breast Cancer (MBC)	Novartis Pharmaceuticals	2012-01-30	PHASE1; PHASE2
NCT01453595	TERMINATED	Renal Cancer	Memorial Sloan Kettering Cancer Center	2011-10	PHASE1; PHASE2
NCT01508104	TERMINATED	Cancer	University of Cincinnati	2012-01	PHASE1
NCT01343498	COMPLETED	Malignant Solid Tumour	SCRI Development Innovations, LLC	2011-04	PHASE1
NCT01856101	TERMINATED	Carcinoma Transitional Cell	Cliniques universitaires Saint-Luc- Université Catholique de Louvain	2013-02	PHASE2
NCT01717898	TERMINATED	Castrate-resistant Prostate Cancer	Charles Ryan	2013-01-31	PHASE1; PHASE2
NCT01195376	COMPLETED	Advanced Solid Tumor	Novartis Pharmaceuticals	2010-10	PHASE1
NCT01337765	COMPLETED	Unspecified Adult Solid Tumor, Protocol Specific; Solid Tumor	Pfizer	2011-07-08	PHASE1
NCT01856101	Terminated	Carcinoma Transitional Cell	Cliniques universitaires Saint-Luc- Université Catholique de Louvain\|Novartis	2013-02	Phase 2
NCT00620594	COMPLETED	Breast Cancer; Advanced Solid Tumors; Cowden Syndrome	Novartis Pharmaceuticals	2006-12-21	PHASE1
NCT01717898	Terminated	Castrate-resistant Prostate Cancer	Charles Ryan\|Novartis Pharmaceuticals\|University of California San Francisco	2013-01-31	Phase 1\|Phase 2
NCT01248494	COMPLETED	Metastatic Breast Cancer	Vanderbilt-Ingram Cancer Center	2010-11	PHASE1
NCT01471847	COMPLETED	Locally Advance Breast Cancer (LABC); Metastatic Breast Cancer (MBC)	Novartis Pharmaceuticals	2012-02	PHASE1
NCT01756118	Completed	Acute Lymphoblastic Leukemia\|Leukemia Myelocytic Acute\|Chronic Myelogenous Leukemia With Crisis of Blast Cells	Goethe University	2012-06	Phase 1
NCT01290406	Withdrawn	Endometrial Cancer	Novartis Pharmaceuticals\|Novartis	2012-03	Phase 2
NCT01288092	Withdrawn	Metastatic Breast Cancer	Novartis Pharmaceuticals\|Novartis	2012-03	Phase 2

(data from https://clinicaltrials.gov, updated on 2021-06-23)

Check the Dactolisib (BEZ235) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Dactolisib selectively binds to the ATP-binding cleft of Class I PI3K isoforms and mTOR, directly blocking enzyme catalytic activity and suppressing downstream phosphorylation of Akt at Ser473 and Thr308. This dual inhibition downregulates key intracellular survival signaling and induces autophagy, thereby suppressing cell proliferation and tumor growth in oncological conditions such as metastatic breast cancer and acute leukemias evaluated in clinical trials.

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>).