Pictilisib (GDC-0941) Clinical Trials

Size	Price	Qty
5mg	USD 147
50mg	USD 590

Clinical Trials

Multiple Phase 1 and Phase 2 clinical trials have evaluated pictilisib (GDC-0941) in healthy volunteers and oncology indications, including advanced solid tumors, non-small cell lung cancer, non-Hodgkin's lymphoma, and triple-negative, HER2-negative, or recurrent breast carcinomas. Sponsored by industry leaders like Genentech Inc. and academic centers such as the Royal Marsden NHS Foundation Trust and Vanderbilt-Ingram Cancer Center, these trials hold completed or terminated recruitment statuses. Key evaluations included Phase 1 pharmacokinetic assessments alongside randomized Phase 2 studies in metastatic breast cancer and non-small cell lung cancer.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02389842	COMPLETED	Advanced Solid Tumours; Breast Cancer	Royal Marsden NHS Foundation Trust	2015-03-25	PHASE1
NCT01437566	COMPLETED	Breast Cancer	Genentech, Inc.	2011-10	PHASE2
NCT01493843	COMPLETED	Non-Small Cell Lung Cancer	Genentech, Inc.	2012-01-20	PHASE2
NCT00960960	COMPLETED	Breast Cancer	Genentech, Inc.	2009-08	PHASE1
NCT01740336	COMPLETED	Breast Cancer	Genentech, Inc.	2013-02-06	PHASE2
NCT00974584	COMPLETED	Non-Squamous Non-Small Cell Lung Cancer	Genentech, Inc.	2009-10	PHASE1
NCT01918306	TERMINATED	Estrogen Receptor Negative Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast; Triple Negative Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer; Triple-negative Breast Cancer	Vanderbilt-Ingram Cancer Center	2013-09	PHASE1; PHASE2
NCT00975182	COMPLETED	Non-Squamous Non-Small Cell Lung Cancer, Solid Cancers	Genentech, Inc.	2009-09	PHASE1
NCT02092831	COMPLETED	Healthy Volunteer	Genentech, Inc.	2014-04	PHASE1
NCT02092831	Completed	Healthy Volunteer	Genentech Inc.	2014-04	Phase 1
NCT00996892	TERMINATED	Solid Tumors	Genentech, Inc.	2009-11	PHASE1
NCT00928330	COMPLETED	Metastatic Breast Cancer	Genentech, Inc.	2009-07	PHASE1
NCT01740336	Completed	Breast Cancer	Genentech Inc.	2013-02-06	Phase 2
NCT00876122	COMPLETED	Non-Hodgkin's Lymphoma, Solid Cancers	Genentech, Inc.	2008-03	PHASE1
NCT00876109	COMPLETED	Solid Cancers	Genentech, Inc.	2007-10	PHASE1
NCT01474668	Completed	Healthy Volunteer	Genentech Inc.	2011-10	Phase 1
NCT01474668	COMPLETED	Healthy Volunteer	Genentech, Inc.	2011-10	PHASE1
NCT01240226	COMPLETED	Healthy Volunteer	Genentech, Inc.	2010-11	PHASE1
NCT01240226	Completed	Healthy Volunteer	Genentech Inc.	2010-11	Phase 1
NCT00999128	COMPLETED	Healthy Volunteers	Genentech, Inc.	2009-10-26	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-09-26)

Check the Pictilisib (GDC-0941) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pictilisib selectively binds to and inhibits class I phosphoinositide 3-kinase (PI3K) isoforms, particularly PI3Kα and PI3Kδ, thereby blocking downstream AKT phosphorylation and intracellular signaling pathways required for cell survival. This biochemical blockade induces autophagy and apoptosis while suppressing cell proliferation, providing therapeutic efficacy against tumor growth in clinical conditions such as breast 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>).