Ravoxertinib (GDC-0994) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

Several Phase 1 clinical trials sponsored by Genentech, Inc. evaluated the safety, tolerability, and pharmacokinetics of Ravoxertinib (GDC-0994) both as monotherapy and in combination with cobimetinib. These studies targeted patients with advanced solid tumors, melanoma, non-small cell lung cancer, and metastatic colorectal cancer. All of these registered trials have completed recruitment, establishing initial clinical safety and pharmacokinetic profiles in oncological settings.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02457793	COMPLETED	Non-Small Cell Lung Cancer, Metastatic Colorectal Cancer, Metastatic Non Small Cell Lung Cancer, Metastatic Cancers, Melanoma	Genentech, Inc.	2015-06-16	PHASE1
NCT01875705	COMPLETED	Solid Tumor	Genentech, Inc.	2013-06-21	PHASE1
NCT02457793	Completed	Non-Small Cell Lung Cancer Metastatic Colorectal Cancer Metastatic Non Small Cell Lung Cancer Metastatic Cancers Melanoma	Genentech Inc.	2015-06-16	Phase 1
NCT01875705	Completed	Solid Tumor	Genentech Inc.	2013-06-21	Phase 1

(data from https://clinicaltrials.gov, updated on 2018-11-20)

Check the Ravoxertinib (GDC-0994) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ravoxertinib selectively binds to and inhibits extracellular signal-regulated kinases 1 and 2 (ERK1/2) with nanomolar potency, thereby suppressing downstream MAPK/ERK signaling and transcriptional programs essential for tumor cell proliferation and survival. By blocking this hyperactive kinase cascade, the inhibitor induces cell cycle arrest and apoptosis, providing a targeted therapeutic strategy to disrupt oncogenic signaling in solid tumors, melanoma, non-small cell lung cancer, and metastatic colorectal 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>).