Ipatasertib (GDC-0068) Clinical Trials

Size	Price	Qty
5mg	USD 270
25mg	USD 790

Clinical Trials

Numerous clinical trials evaluate the investigational compound ipatasertib (GDC-0068) across Phase 1, Phase 2, and Phase 3 studies targeting advanced solid tumors, castrate-resistant prostate cancer, triple-negative breast cancer, and ovarian cancer. These monotherapy and combination studies range from actively recruiting to completed and are sponsored by pharmaceutical companies like Genentech and Hoffmann-La Roche alongside cooperative groups and academic centers, including the National Cancer Institute, Queen Mary University of London, and Alliance Foundation Trials.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT05862285	RECRUITING	Cancer	Hoffmann-La Roche	2023-06-01	PHASE3
NCT04589845	ACTIVE_NOT_RECRUITING	Solid Tumors	Hoffmann-La Roche	2021-01-18	PHASE2
NCT03424005	RECRUITING	Metastatic Breast Cancer	Hoffmann-La Roche	2018-03-30	PHASE1; PHASE2
NCT05564377	RECRUITING	Advanced Malignant Solid Neoplasm; Anatomic Stage III Breast Cancer AJCC v8; Anatomic Stage IV Breast Cancer AJCC v8; Locally Advanced Malignant Solid Neoplasm; Malignant Female Reproductive System Neoplasm; Metastatic HER2-Negative Breast Carcinoma; Metastatic Malignant Solid Neoplasm; Recurrent Endometrial Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Malignant Female Reproductive System Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Unresectable HER2-Negative Breast Carcinoma; Unresectable Malignant Solid Neoplasm	National Cancer Institute (NCI)	2023-04-07	PHASE2
NCT05332561	RECRUITING	Early-stage Breast Cancer	German Cancer Research Center	2023-06-29	PHASE2
NCT04802759	RECRUITING	Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer	Hoffmann-La Roche	2021-06-22	PHASE1; PHASE2
NCT04931342	ACTIVE_NOT_RECRUITING	Ovarian Cancer	Hoffmann-La Roche	2021-10-07	PHASE2
NCT05172245	RECRUITING	Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8; Head and Neck Carcinoma of Unknown Primary; Locally Advanced Head and Neck Squamous Cell Carcinoma; Locally Advanced Hypopharyngeal Squamous Cell Carcinoma; Locally Advanced Laryngeal Squamous Cell Carcinoma; Locally Advanced Nasal Cavity Squamous Cell Carcinoma; Locally Advanced Oral Cavity Squamous Cell Carcinoma; Locally Advanced Oropharyngeal Squamous Cell Carcinoma; Locally Advanced Paranasal Sinus Squamous Cell Carcinoma; Locally Advanced Sinonasal Squamous Cell Carcinoma; Maxillary Sinus Squamous Cell Carcinoma; Stage III Hypopharyngeal Carcinoma AJCC v8; Stage III Laryngeal Cancer AJCC v8; Stage III Lip and Oral Cavity Cancer AJCC v8; Stage III Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage III Sinonasal Cancer AJCC v8; Stage IVA Hypopharyngeal Carcinoma AJCC v8; Stage IVA Laryngeal Cancer AJCC v8; Stage IVA Lip and Oral Cavity Cancer AJCC v8; Stage IVA Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVA Sinonasal Cancer AJCC v8; Stage IVB Hypopharyngeal Carcinoma AJCC v8; Stage IVB Laryngeal Cancer AJCC v8; Stage IVB Lip and Oral Cavity Cancer AJCC v8; Stage IVB Oropharyngeal (p16-Negative) Carcinoma AJCC v8; Stage IVB Sinonasal Cancer AJCC v8	National Cancer Institute (NCI)	2022-09-19	PHASE1
NCT05172258	ACTIVE_NOT_RECRUITING	Head and Neck Squamous Cell Carcinoma; Metastatic Head and Neck Squamous Cell Carcinoma; Metastatic Hypopharyngeal Squamous Cell Carcinoma; Metastatic Laryngeal Squamous Cell Carcinoma; Metastatic Oral Cavity Squamous Cell Carcinoma; Metastatic Oropharyngeal Squamous Cell Carcinoma; Recurrent Head and Neck Squamous Cell Carcinoma; Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Oral Cavity Squamous Cell Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Stage IV Hypopharyngeal Carcinoma AJCC v8; Stage IV Laryngeal Cancer AJCC v8; Stage IV Lip and Oral Cavity Cancer AJCC v8; Stage IV Oropharyngeal (p16-Negative) Carcinoma AJCC v8	National Cancer Institute (NCI)	2022-07-26	PHASE2
NCT04920708	ACTIVE_NOT_RECRUITING	Metastatic Breast Cancer; ER+ Breast Cancer; Advanced Breast Cancer	Royal Marsden NHS Foundation Trust	2022-12-28	PHASE2
NCT05554380	ACTIVE_NOT_RECRUITING	Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm	National Cancer Institute (NCI)	2023-09-22	PHASE2
NCT05538897	ACTIVE_NOT_RECRUITING	FIGO Grade 1 Endometrial Endometrioid Adenocarcinoma; FIGO Grade 2 Endometrial Endometrioid Adenocarcinoma; Metastatic Endometrial Endometrioid Adenocarcinoma; Recurrent Endometrial Endometrioid Adenocarcinoma	National Cancer Institute (NCI)	2023-03-31	PHASE1; PHASE2
NCT02465060	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma	National Cancer Institute (NCI)	2015-08-17	PHASE2
NCT04486352	RECRUITING	Endometrial Cancer	Alliance Foundation Trials, LLC.	2021-10-20	PHASE1; PHASE2
NCT05498896	ACTIVE_NOT_RECRUITING	Triple Negative Breast Cancer	Queen Mary University of London	2018-12-19	PHASE2
NCT04739202	COMPLETED	Gastric Adenocarcinoma; Metastatic Gastric Cancer; Metastatic Adenocarcinoma; Advanced Gastric Carcinoma	Hospices Civils de Lyon	2021-03-19	PHASE2
NCT03673787	ACTIVE_NOT_RECRUITING	Solid Tumor; Glioblastoma Multiforme; Prostate Cancer Metastatic	Institute of Cancer Research, United Kingdom	2018-08-13	PHASE1; PHASE2
NCT03337698	TERMINATED	Carcinoma, Non-Small-Cell Lung	Hoffmann-La Roche	2017-12-27	PHASE1; PHASE2
NCT04650581	ACTIVE_NOT_RECRUITING	Breast Cancer	Canadian Cancer Trials Group	2021-01-27	PHASE3
NCT05276973	ACTIVE_NOT_RECRUITING	Fallopian Tube Endometrioid Adenocarcinoma; Fallopian Tube High Grade Serous Adenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian High Grade Serous Adenocarcinoma; Primary Peritoneal Endometrioid Adenocarcinoma; Primary Peritoneal High Grade Serous Adenocarcinoma; Stage III Fallopian Tube Cancer AJCC v8; Stage III Ovarian Cancer AJCC v8; Stage III Primary Peritoneal Cancer AJCC v8; Stage IV Fallopian Tube Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Primary Peritoneal Cancer AJCC v8; Unresectable Fallopian Tube Endometrioid Adenocarcinoma; Unresectable Fallopian Tube High Grade Serous Adenocarcinoma; Unresectable Ovarian Endometrioid Adenocarcinoma; Unresectable Ovarian High Grade Serous Adenocarcinoma; Unresectable Primary Peritoneal Endometrioid Adenocarcinoma; Unresectable Primary Peritoneal High Grade Serous Adenocarcinoma	National Cancer Institute (NCI)	2022-09-08	PHASE1
NCT04551521	COMPLETED	Metastatic or Locally Advanced Malignancies	German Cancer Research Center	2021-10-13	PHASE2
NCT04591431	UNKNOWN	Breast Cancer; Gastrointestinal Cancer; Non Small Cell Lung Cancer; Other Cancer	Fondazione per la Medicina Personalizzata	2020-10-07	PHASE2
NCT03385655	ACTIVE_NOT_RECRUITING	Prostate Cancer	Canadian Cancer Trials Group	2018-08-01	PHASE2
NCT03280563	COMPLETED	Breast Neoplasms	Hoffmann-La Roche	2017-12-22	PHASE1; PHASE2
NCT04467801	UNKNOWN	NSCLC Stage IV; NSCLC Stage IIIB	Jun Zhang, MD, PhD	2021-09-14	PHASE2
NCT04632992	COMPLETED	Advanced Unresectable or Metastatic Solid Malignancy	Genentech, Inc.	2021-01-13	PHASE2
NCT04464174	COMPLETED	Triple Negative Breast Cancer	MedSIR	2020-10-08	PHASE2
NCT04060862	TERMINATED	Breast Cancer	Hoffmann-La Roche	2019-11-21	PHASE1
NCT03395899	COMPLETED	Breast Cancer; Estrogen Receptor-positive Breast Cancer	Queen Mary University of London	2017-12-21	PHASE2
NCT06400251	ACTIVE_NOT_RECRUITING	Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma	National Cancer Institute (NCI)	2019-08-08	PHASE2
NCT04341259	COMPLETED	Solid Tumors	Hoffmann-La Roche	2020-11-03	PHASE1
NCT04177108	COMPLETED	Triple-Negative Breast Cancer	Hoffmann-La Roche	2019-11-25	PHASE3
NCT03498521	COMPLETED	Cancer of Unknown Primary Site	Hoffmann-La Roche	2018-07-10	PHASE2
NCT03853707	COMPLETED	Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma; Prognostic Stage IV Breast Cancer AJCC v8	City of Hope Medical Center	2019-03-04	PHASE1; PHASE2
NCT03337724	COMPLETED	Breast Cancer	Hoffmann-La Roche	2018-01-06	PHASE3
NCT03959891	ACTIVE_NOT_RECRUITING	Breast Cancer	Massachusetts General Hospital	2019-05-30	PHASE1
NCT04404140	TERMINATED	Castration-Resistant Prostatic Cancer	Hoffmann-La Roche	2020-07-09	PHASE1
NCT04561817	WITHDRAWN	Ovarian Neoplasms	Icahn School of Medicine at Mount Sinai	2020-10-01	PHASE2
NCT04737109	TERMINATED	Castrate Resistant Prostate Cancer	David VanderWeele	2021-07-13	PHASE1; PHASE2
NCT03800836	COMPLETED	Breast Cancer	Hoffmann-La Roche	2018-02-13	PHASE1
NCT03840200	COMPLETED	Breast Cancer; Prostate Cancer; Ovarian Cancer	Hoffmann-La Roche	2019-06-12	PHASE1
NCT04253561	COMPLETED	Metastatic Breast Cancer	SOLTI Breast Cancer Research Group	2020-02-25	PHASE1
NCT01362374	COMPLETED	Neoplasms	Genentech, Inc.	2011-07-11	PHASE1
NCT03072238	COMPLETED	Metastatic Prostate Cancer	Hoffmann-La Roche	2017-06-30	PHASE3
NCT03341884	COMPLETED	Hepatic Insufficiency	Genentech, Inc.	2017-11-09	PHASE1
NCT03222310	COMPLETED	Healthy Volunteers	Hoffmann-La Roche	2017-07-18	PHASE1
NCT02301988	COMPLETED	Breast Cancer	Genentech, Inc.	2015-02-17	PHASE2
NCT02162719	COMPLETED	Breast Neoplasms	Genentech, Inc.	2014-08-19	PHASE2
NCT02536391	COMPLETED	Cancer	Genentech, Inc.	2015-10	PHASE1
NCT01485861	COMPLETED	Prostate Cancer	Genentech, Inc.	2012-01-11	PHASE1; PHASE2
NCT01896531	COMPLETED	Gastric Cancer	Genentech, Inc.	2013-08-14	PHASE2
NCT02390492	COMPLETED	Healthy Volunteer	Genentech, Inc.	2015-03	PHASE1
NCT01090960	COMPLETED	Solid Cancers	Genentech, Inc.	2010-03	PHASE1
NCT01562275	COMPLETED	Neoplasms	Genentech, Inc.	2012-04	PHASE1
NCT02063581	COMPLETED	Healthy Volunteer	Genentech, Inc.	2014-02	PHASE1
NCT01090960	Completed	Solid Cancers	Genentech Inc.	2010-03	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the Ipatasertib (GDC-0068) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ipatasertib (GDC-0068) is a potent, ATP-competitive pan-Akt inhibitor that selectively targets Akt1, Akt2, and Akt3 isoforms to block intracellular Akt signaling and inhibit the phosphorylation of downstream effectors such as PRAS40, S6, and eIF4G while promoting FOXO nuclear localization. This downstream signaling blockade suppresses cell proliferation and induces apoptosis in tumor cells harboring PI3K/Akt/mTOR pathway alterations, demonstrating significant clinical relevance for treating Akt-driven malignancies including prostate cancer, triple-negative breast cancer, and other advanced solid tumors 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>).