TAK-228

DRUG8 trials

Sponsors

Millennium Pharmaceuticals, Inc., Gary Schwartz, M.D. Anderson Cancer Center, Fox Chase Cancer Center, The Methodist Hospital Research Institute

Conditions

Advanced Nonhematologic MalignanciesAdvanced Nonhematological NeoplasmsAdvanced Solid TumorBreast CancerEstrogen Receptor Positive Breast CancerMalignant Neoplasms of Digestive OrgansMalignant Neoplasms of Female Genital OrgansMalignant Neoplasms of Lip Oral Cavity and Pharynx

Phase 1

A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies

CompletedNCT01899053

Millennium Pharmaceuticals, Inc.Advanced Nonhematologic Malignancies

Start: 2013-06-28End: 2018-04-30Updated: 2019-10-30

Neoadjuvant Run-In Study With TAK-228 Followed by Letrozole/TAK-228 in Women With High-Risk ER+/HER2- Breast Cancer

WithdrawnNCT02619669

Gary SchwartzBreast Cancer

Start: 2017-04-20End: 2019-06-14Updated: 2020-03-12

Alisertib and TAK-228 in Participants With Human Papilloma Virus (HPV) Associated Malignancies

WithdrawnNCT02812056

M.D. Anderson Cancer CenterMalignant Neoplasms of Digestive Organs, Malignant Neoplasms of Female Genital Organs, Malignant Neoplasms of Lip Oral Cavity and Pharynx +1

Start: 2016-09-30Updated: 2017-03-27

Evaluation of the Safety and Tolerability of TAK-228 With TAK-117 and Paclitaxel in Advanced Solid Tumors

CompletedNCT03154294

Avera McKennan Hospital & University Health CenterAdvanced Solid Tumor

Start: 2017-07-06End: 2022-11-20Updated: 2024-07-26

A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK) of TAK-228 as Single Agent in Adult East Asian Participants With Advanced Nonhematological Malignancies

TerminatedNCT03370302

Calithera Biosciences, IncAdvanced Nonhematological Neoplasms

Start: 2018-01-17End: 2019-08-28Updated: 2023-02-08

Phase 2

Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas

TerminatedNCT02987959

Fox Chase Cancer CenterSoft-tissue Sarcoma

Start: 2017-02-21End: 2020-07-24Updated: 2022-10-14

TAK-228 Plus Tamoxifen in Patients With ER-Positive, HER2-negative Breast Cancer

CompletedNCT02988986

The Methodist Hospital Research InstituteEstrogen Receptor Positive Breast Cancer

Start: 2017-04-24End: 2019-03-30Updated: 2021-09-22

Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma

CompletedNCT03097328

Bradley A. McGregor, MDRenal Cell Carcinoma

Start: 2017-08-01End: 2024-04-24Updated: 2024-04-29

Related Papers

Sapanisertib and serabelisib (PIKTOR) with paclitaxel and a diet substudy in patients with advanced/recurrent endometrial cancer (GOG-3111).

Journal of Clinical Oncology2025-05-28

Serabelisib, sapanisertib (PIKTOR) and paclitaxel: A combinatorial approach to improve PI3K/mTOR/AKT pathway inhibition and treatment response in solid tumors.

Journal of Clinical Oncology2024-06-01

Phase I study of sapanisertib with carboplatin and paclitaxel in mTOR pathway altered solid malignancies.

2023-04-185 citations

Phase I dose escalation study of dual PI3K/mTOR inhibition by Sapanisertib and Serabelisib in combination with paclitaxel in patients with advanced solid tumors.

2022-07-1516 citations

Biomarker-Based Phase II Study of Sapanisertib (TAK-228): An mTORC1/2 Inhibitor in Patients With Refractory Metastatic Renal Cell Carcinoma

JCO Precision Oncology2022-02-169 citations

A Phase 1 Study of Sapanisertib (TAK-228) in East Asian Patients with Advanced Nonhematological Malignancies.

2021-11-297 citations

Final results of phase 1 evaluation of the safety and clinical activity of sapanisertib in combination with serabelisib and paclitaxel in patients with advanced ovarian, endometrial, or breast cancer.

Journal of Clinical Oncology2021-05-202 citations

Biomarker-based phase II study of sapanisertib (TAK-228), an mTORC1/2 inhibitor in patients with refractory metastatic renal cell carcinoma (mRCC).

Journal of Clinical Oncology2021-02-201 citations

Phase 1 study of mTORC1/2 inhibitor sapanisertib (TAK-228) in advanced solid tumours, with an expansion phase in renal, endometrial or bladder cancer.

2020-09-1170 citations

Phase 1 Study to Evaluate the Effect of the Investigational Anticancer Agent Sapanisertib on the QTc Interval in Patients With Advanced Solid Tumors

Clinical Pharmacology in Drug Development2020-06-0212 citations

Results of a phase Ib trial evaluating the safety and clinical activity of sapanisertib (TAK 228) in combination with serabelisib (TAK 117) and paclitaxel in patients with advanced ovarian, endometrial, or breast cancer.

Journal of Clinical Oncology2020-05-209 citations

Open label, phase II trial of neoadjuvant TAK-228 plus tamoxifen in patients with estrogen receptor (ER)-positive, human epidermal growth factor receptor type 2 (HER2)-negative breast cancer-ANETT.

Journal of Clinical Oncology2019-05-202 citations

Abstract C176: The combination of mTORC1/2 and PI3Kα inhibition alleviates PI3K pathway reactivation and leads to significant antitumor activity in multiple preclinical xenograft models.

Molecular Cancer Therapeutics2013-11-012 citations