Serabelisib

Overview

Serabelisib is under investigation in clinical trial NCT02625259 (A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With an Insulin-Suppressing Diet in Patients With Advanced/Recurrent Endometrial Cancer	2024/06/17	NCT06463028	Phase 2	Recruiting	Faeth Therapeutics
Combination of Serabelisib and Insulin Suppressing Diet with or Without Nab-paclitaxel in Subjects with Advanced Solid Tumors with PIK3CA Mutations	2022/03/29	NCT05300048	Phase 1	Active, not recruiting	Faeth Therapeutics
A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors	2019/08/29	NCT04073680	Phase 1	UNKNOWN	Petra Pharma
Evaluation of the Safety and Tolerability of TAK-228 With TAK-117 and Paclitaxel in Advanced Solid Tumors	2017/05/16	NCT03154294	Phase 1	Completed	Avera McKennan Hospital & University Health Center
A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer	2016/03/31	NCT02725268	Phase 2	Completed	Millennium Pharmaceuticals, Inc.
MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma	2016/03/31	NCT02724020	Phase 2	Completed	Millennium Pharmaceuticals, Inc.
A Study to Evaluate the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics of TAK-117 (MLN1117) in Healthy Participants	2015/12/09	NCT02625259	Phase 1	Completed	Millennium Pharmaceuticals, Inc.
MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma	2015/09/16	NCT02551055	Phase 1	Terminated	Millennium Pharmaceuticals, Inc.
Docetaxel With or Without TAK-117 (MLN1117) in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer	2015/03/19	NCT02393209	Phase 1	Terminated	Millennium Pharmaceuticals, Inc.
A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies	2013/07/15	NCT01899053	Phase 1	Completed	Millennium Pharmaceuticals, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

Faeth Therapeutics Advances Novel Three-Pronged Approach for Metabolism-Driven Cancers with Promising Preclinical Results

4 months ago

Faeth Therapeutics has published preclinical proof-of-concept data in the British Journal of Cancer supporting their multi-node PIKTOR approach, which combines dual PI3K/AKT/mTOR pathway inhibitors with an insulin-suppressing diet.

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