Tolinapant

Overview

ASTX660 is under investigation in clinical trial NCT02503423 (Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas).

Background

ASTX660 is under investigation in clinical trial NCT02503423 (Phase 1-2 Study of ASTX660 in Subjects With Advanced Solid Tumors and Lymphomas).

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Testing the Addition of an Investigational Anti-Cancer Drug, ASTX660 (Tolinapant), to a Usual Chemotherapy Treatment (Eribulin) for Treatment of Advanced Triple Negative Breast Cancer	2024/09/19	NCT06590558	Phase 1	Suspended	National Cancer Institute (NCI)
Testing the Addition of ASTX660 (Tolinapant) to the Usual Chemotherapy Treatment (Paclitaxel With or Without Bevacizumab) in Patients With Recurrent Ovarian Cancer	2024/05/01	NCT06393751	Phase 1	Withdrawn	National Cancer Institute (NCI)
Preoperative Radiotherapy And ASTX660 in Rectum Cancer	2023/06/22	NCT05912075	Phase 1	Recruiting	Gustave Roussy, Cancer Campus, Grand Paris
A Study of Tolinapant in Combination With Oral Decitabine/Cedazuridine and Oral Decitabine/Cedazuridine Alone in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma (R/R PTCL)	2022/06/03	NCT05403450	Phase 1	Active, not recruiting	Taiho Oncology, Inc.
Tolinapant and Radiation for Cisplatin-Ineligible, Previously Untreated, Locally Advanced Head and Neck Cancer	2022/02/18	NCT05245682	Early Phase 1	Active, not recruiting	Emory University
ASTEROID: A Trial of ASTX660 in Combination With Pembrolizumab	2021/10/18	NCT05082259	Phase 1	Recruiting	Institute of Cancer Research, United Kingdom
Effect of Food on the Pharmacokinetics of ASTX660 in Healthy Volunteers	2020/07/21	NCT04479800	Phase 1	Completed	Astex Pharmaceuticals, Inc.
A Study to Investigate the Effect of CYP3A4 Inhibition on the Single Dose Pharmacokinetics of ASTX660 and the Effect of a Single Dose of ASTX660 on the Pharmacokinetics of the CYP3A4 Substrate Midazolam	2020/06/01	NCT04411030	Phase 1	Completed	Astex Pharmaceuticals, Inc.
A Phase I/II Study of ASTX660 in Patients With Relapsed or Refractory T-cell Lymphoma	2020/04/24	NCT04362007	Phase 1	Terminated	Otsuka Pharmaceutical Co., Ltd.
A Study of ASTX660 as a Single Agent and in Combination With ASTX727 in Subjects With Relapsed/Refractory Acute Myeloid Leukemia (AML)	2019/11/07	NCT04155580	Phase 1	Terminated	Astex 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.

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