Onalespib (AT13387) Clinical Trials

Size	Price	Qty
5mg	USD 270
50mg	USD 970

Clinical Trials

Onalespib (AT13387) has been evaluated across several Phase 1 and Phase 2 clinical trials—sponsored primarily by the National Cancer Institute and Astex Pharmaceuticals—investigating its safety, tolerability, and efficacy as monotherapy or combination therapy. These studies targeted various advanced malignancies, including triple-negative breast cancer, non-small cell lung cancer, platinum-resistant ovarian carcinoma, head and neck squamous cell carcinoma, BRAF-mutant melanoma, and gastrointestinal stromal tumors. Recruitment statuses across protocols range from completed interventions, such as combination regimens with erlotinib or olaparib, to terminated and withdrawn trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT02474173	TERMINATED	Advanced Breast Carcinoma; Metastatic Breast Carcinoma; Stage III Breast Cancer AJCC v7; Stage IIIA Breast Cancer AJCC v7; Stage IIIB Breast Cancer AJCC v7; Stage IIIC Breast Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7; Triple-Negative Breast Carcinoma	National Cancer Institute (NCI)	2016-01-15	PHASE1
NCT02535338	COMPLETED	Recurrent Lung Non-Small Cell Carcinoma; Stage IV Lung Non-Small Cell Cancer AJCC v7	National Cancer Institute (NCI)	2016-04-11	PHASE1; PHASE2
NCT02572453	TERMINATED	Recurrent Anaplastic Large Cell Lymphoma; Recurrent Diffuse Large B-Cell Lymphoma; Recurrent Mantle Cell Lymphoma; Recurrent Transformed Non-Hodgkin Lymphoma; Refractory Anaplastic Large Cell Lymphoma; Refractory Diffuse Large B-Cell Lymphoma; Refractory Mantle Cell Lymphoma; Refractory Transformed Non-Hodgkin Lymphoma	National Cancer Institute (NCI)	2016-04-04	PHASE2
NCT02503709	COMPLETED	Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Solid Neoplasm	National Cancer Institute (NCI)	2016-09-30	PHASE1
NCT02898207	COMPLETED	Metastatic High Grade Fallopian Tube Serous Adenocarcinoma; Metastatic Malignant Solid Neoplasm; Metastatic Primary Peritoneal Serous Adenocarcinoma; Metastatic Triple-Negative Breast Carcinoma; Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Ovarian Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; Recurrent Breast Carcinoma; Recurrent High Grade Fallopian Tube Serous Adenocarcinoma; Recurrent High Grade Ovarian Serous Adenocarcinoma; Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma; Recurrent Triple-Negative Breast Carcinoma; Refractory Fallopian Tube Serous Adenocarcinoma; Refractory Ovarian Serous Adenocarcinoma; Refractory Primary Peritoneal Serous Adenocarcinoma; Refractory Triple-Negative Breast Carcinoma; Unresectable High Grade Fallopian Tube Serous Adenocarcinoma; Unresectable Malignant Solid Neoplasm; Unresectable Primary Peritoneal Serous Adenocarcinoma	National Cancer Institute (NCI)	2017-05-19	PHASE1
NCT02381535	COMPLETED	Stage III Hypopharyngeal Squamous Cell Carcinoma AJCC v7; Stage III Laryngeal Squamous Cell Carcinoma AJCC v6 and v7; Stage III Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7; Stage III Oropharyngeal Squamous Cell Carcinoma AJCC v7; Stage IVA Hypopharyngeal Squamous Cell Carcinoma AJCC v7; Stage IVA Laryngeal Squamous Cell Carcinoma AJCC v7; Stage IVA Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7; Stage IVA Oropharyngeal Squamous Cell Carcinoma AJCC v7; Stage IVB Hypopharyngeal Squamous Cell Carcinoma AJCC v7; Stage IVB Laryngeal Squamous Cell Carcinoma AJCC v7; Stage IVB Oral Cavity Squamous Cell Carcinoma AJCC v6 and v7; Stage IVB Oropharyngeal Squamous Cell Carcinoma AJCC v7	National Cancer Institute (NCI)	2015-10-22	PHASE1
NCT02097225	TERMINATED	BRAF V600E Mutation Present; BRAF V600K Mutation Present; Metastatic Malignant Solid Neoplasm; Metastatic Melanoma; Stage III Cutaneous Melanoma AJCC v7; Stage IIIA Cutaneous Melanoma AJCC v7; Stage IIIB Cutaneous Melanoma AJCC v7; Stage IIIC Cutaneous Melanoma AJCC v7; Stage IV Cutaneous Melanoma AJCC v6 and v7; Unresectable Solid Neoplasm	National Cancer Institute (NCI)	2014-05-29	PHASE1
NCT02627430	WITHDRAWN	Adult Solid Neoplasm; Estrogen Receptor Negative; Fallopian Tube Serous Neoplasm; HER2/Neu Negative; Ovarian Serous Adenocarcinoma; Ovarian Serous Tumor; Primary Peritoneal Serous Adenocarcinoma; Progesterone Receptor Negative; Recurrent Breast Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Triple-Negative Breast Carcinoma	National Cancer Institute (NCI)	2016-03	PHASE1
NCT02898207	Completed	Metastatic High Grade Fallopian Tube Serous Adenocarcinoma\|Metastatic Malignant Solid Neoplasm\|Metastatic Primary Peritoneal Serous Adenocarcinoma\|Metastatic Triple-Negative Breast Carcinoma\|Platinum-Resistant Fallopian Tube Carcinoma\|Platinum-Resistant Ovarian Carcinoma\|Platinum-Resistant Primary Peritoneal Carcinoma\|Recurrent Breast Carcinoma\|Recurrent High Grade Fallopian Tube Serous Adenocarcinoma\|Recurrent High Grade Ovarian Serous Adenocarcinoma\|Recurrent Primary Peritoneal High Grade Serous Adenocarcinoma\|Recurrent Triple-Negative Breast Carcinoma\|Refractory Fallopian Tube Serous Adenocarcinoma\|Refractory Ovarian Serous Adenocarcinoma\|Refractory Primary Peritoneal Serous Adenocarcinoma\|Refractory Triple-Negative Breast Carcinoma\|Unresectable High Grade Fallopian Tube Serous Adenocarcinoma\|Unresectable Malignant Solid Neoplasm\|Unresectable Primary Peritoneal Serous Adenocarcinoma	National Cancer Institute (NCI)	2017-05-19	Phase 1
NCT01712217	COMPLETED	Non-small Cell Lung Cancer(NSCLC)	Astex Pharmaceuticals, Inc.	2012-10	PHASE1; PHASE2
NCT01685268	COMPLETED	Prostate Cancer	Astex Pharmaceuticals, Inc.	2012-09	PHASE1; PHASE2
NCT01246102	COMPLETED	Solid Tumors; Breast Cancer	National Cancer Institute (NCI)	2010-11-19	PHASE1
NCT00878423	COMPLETED	Metastatic Solid Tumors	Astex Pharmaceuticals, Inc.	2008-05	PHASE1
NCT01294202	COMPLETED	Gastrointestinal Stromal Tumor (GIST)	Astex Pharmaceuticals, Inc.	2011-03	PHASE2

(data from https://clinicaltrials.gov, updated on 2022-11-04)

Check the Onalespib (AT13387) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Onalespib selectively binds to heat shock protein 90 (Hsp90) with high affinity, disrupting its molecular chaperone activity and promoting the degradation of oncogenic client proteins involved in signal transduction. This targeted biochemical blockade suppresses downstream tumor cell proliferation and survival, providing a mechanistic rationale for its investigation in clinical trials for advanced malignancies, including triple-negative 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>).