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Serabelisib

Generic Name
Serabelisib
Drug Type
Small Molecule
Chemical Formula
C19H17N5O3
CAS Number
1268454-23-4
Unique Ingredient Identifier
43J9Q56T3W
Background

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).

Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With Diet in Patients With Advanced/Recurrent Endometrial Cancer

Phase 2
Recruiting
Conditions
Endometrial Cancer
Interventions
First Posted Date
2024-06-17
Last Posted Date
2025-03-17
Lead Sponsor
Faeth Therapeutics
Target Recruit Count
40
Registration Number
NCT06463028
Locations
🇺🇸

UC San Diego Moores Cancer Center, La Jolla, California, United States

🇺🇸

Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States

🇺🇸

Florida Cancer Specialists, North, Saint Petersburg, Florida, United States

and more 7 locations

Combination of Serabelisib and Insulin Suppressing Diet with or Without Nab-paclitaxel in Subjects with Advanced Solid Tumors with PIK3CA Mutations

Phase 1
Active, not recruiting
Conditions
Advanced Solid Tumor
PIK3CA Mutation
PTEN Loss of Function Mutation
Interventions
Other: Insulin Suppressing Diet
First Posted Date
2022-03-29
Last Posted Date
2025-02-27
Lead Sponsor
Faeth Therapeutics
Target Recruit Count
68
Registration Number
NCT05300048
Locations
🇺🇸

New Jersey Cancer Care, PA, Belleville, New Jersey, United States

🇺🇸

Englewood Health, Englewood, New Jersey, United States

🇺🇸

Northwell Health, Lake Success, New York, United States

and more 14 locations

A Phase 1b/2 Study of Serabelisib in Combination With Canagliflozin in Patients With Advanced Solid Tumors

Phase 1
Conditions
Endometrial Cancer
Lung Cancer
Colo-rectal Cancer
Breast Cancer
Head and Neck Cancer
Interventions
First Posted Date
2019-08-29
Last Posted Date
2020-05-21
Lead Sponsor
Petra Pharma
Target Recruit Count
60
Registration Number
NCT04073680

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

Phase 1
Completed
Conditions
Advanced Solid Tumor
Interventions
First Posted Date
2017-05-16
Last Posted Date
2024-07-26
Lead Sponsor
Avera McKennan Hospital & University Health Center
Target Recruit Count
19
Registration Number
NCT03154294
Locations
🇺🇸

Avera Cancer Institute, Sioux Falls, South Dakota, United States

MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma

Phase 2
Completed
Conditions
Clear-cell Metastatic Renal Cell Carcinoma
Interventions
First Posted Date
2016-03-31
Last Posted Date
2021-11-19
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
96
Registration Number
NCT02724020
Locations
🇮🇹

Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi, Bologna, Italy

🇮🇹

Istituto Nazionale Tumori Fondazione G. Pascale, Napoli, Italy

🇫🇷

Groupe Hospitalier Pitie-Salpetriere, Paris cedex 13, Paris, France

and more 33 locations

A Study of Sapanisertib, Combination of Sapanisertib With MLN1117, Paclitaxel and Combination of Sapanisertib With Paclitaxel in Women With Endometrial Cancer

Phase 2
Completed
Conditions
Endometrial Neoplasms
Interventions
First Posted Date
2016-03-31
Last Posted Date
2021-11-24
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
241
Registration Number
NCT02725268
Locations
🇺🇸

Florida Cancer Specialists, West Palm Beach, Florida, United States

🇺🇸

University of Kansas Medical Center Research Institute, Inc., Westwood, Kansas, United States

🇺🇸

University of Pittsburgh Medical Center Cancer Center at Magee-Womens Hospital, Pittsburgh, Pennsylvania, United States

and more 74 locations

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

Phase 1
Completed
Conditions
Neoplasm, Advanced or Metastatic
Interventions
First Posted Date
2015-12-09
Last Posted Date
2018-01-08
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
54
Registration Number
NCT02625259

MLN1117 in Combination With Docetaxel, Paclitaxel, and Other Investigational Anticancer Agents to Treat Participants With Gastric and Gastroesophageal Adenocarcinoma

Phase 1
Terminated
Conditions
Advanced and Metastatic Gastric or Gastroesophageal Adenocarcinoma
Interventions
First Posted Date
2015-09-16
Last Posted Date
2019-09-20
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
32
Registration Number
NCT02551055

Docetaxel With or Without TAK-117 (MLN1117) in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer

Phase 1
Terminated
Conditions
Non-small Cell Lung Cancer
Interventions
First Posted Date
2015-03-19
Last Posted Date
2018-02-07
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
14
Registration Number
NCT02393209

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

Phase 1
Completed
Conditions
Advanced Nonhematologic Malignancies
Interventions
First Posted Date
2013-07-15
Last Posted Date
2019-10-30
Lead Sponsor
Millennium Pharmaceuticals, Inc.
Target Recruit Count
101
Registration Number
NCT01899053
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