Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma

Status Completed

Clinical Trial Summary

There has not been any systemic therapy approved in the United States or in Europe for treating advanced or recurrent endometrial cancer (EC). This study will evaluate the safety and preliminary efficacy of XL147 in advanced or recurrent EC.

Constitutively active phosphatidylinositol-3 kinase (PI3K)/phosphatase and tensin homolog on chromosome 10 (PTEN) pathway signaling is common in EC and involved in the development and/or progression of the disease. PTEN deficiency and/or activating mutations/amplification in the PIK3CA gene that encodes the p110α catalytic subunit of PI3K have been frequently detected in EC patients. XL147 is a potent and highly selective inhibitor of the Class I PI3K family of lipid kinases. In addition, in vivo preclinical data have demonstrated that XL147 targets both proximal and distal signaling in the PI3K/PTEN pathway. Therefore, XL147 may have utility in the treatment of subjects with advanced or recurrent EC.

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01013324
Study type	Interventional
Source	Sanofi
Contact
Status	Completed
Phase	Phase 2
Start date	January 2010
Completion date	March 2013

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05796518` - Feasibility of a Patient Directed Tool to Assess Heart Health Among Endometrial Cancer Survivors	N/A
Recruiting	`NCT05489211` - Study of Dato-Dxd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)	Phase 2
Active, not recruiting	`NCT03667716` - COM701 (an Inhibitor of PVRIG) in Subjects With Advanced Solid Tumors.	Phase 1
Active, not recruiting	`NCT03170960` - Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors	Phase 1/Phase 2
Not yet recruiting	`NCT06463028` - Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel, Serabelisib With Paclitaxel, and Paclitaxel Alone in Patients With Advanced/Recurrent Endometrial Cancer	Phase 2
Recruiting	`NCT06036836` - Study of Favezelimab Coformulated With Pembrolizumab (MK-4280A) in Participants With Selected Solid Tumors (MK-4280A-010)	Phase 2
Terminated	`NCT04586335` - Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.	Phase 1
Completed	`NCT03820024` - MOtiVating Endometrial Cancer Survivors With Activity Monitors and Tailored Feedback	N/A
Active, not recruiting	`NCT05082025` - Phase 2 Study of PI3K Inhibitor Copanlisib in Combination With Fulvestrant in Selected ER+ and/or PR+ Cancers With PI3K (PIK3CA, PIK3R1) and/or PTEN Alterations	Phase 2
Active, not recruiting	`NCT00587886` - Estrogen, Diet, Genetics and Endometrial Cancer
Completed	`NCT05378152` - Assessing the Benefit of Pipelle Biopsy in Patients With Postmenopausal Bleeding and an Atrophic-appearing Cavity	N/A
Suspended	`NCT05124743` - HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors
Recruiting	`NCT03876860` - An Enhanced Vaginal Dilator to Reduce Radiation-Induced Vaginal Stenosis	N/A
Recruiting	`NCT04569773` - Choosing Ovarian Preservation or Removal Before Surgery for Endometrial Cancer
Completed	`NCT04534309` - Behavioral Weight Loss Program for Cancer Survivors in Maryland	N/A
Not yet recruiting	`NCT06366347` - ALPINE: Maintenance Letrozole/Abemaciclib vs Pembrolizumab	Phase 2
Not yet recruiting	`NCT05998798` - Revealing Engagement Patterns Among Endometrial Cancer Patients
Not yet recruiting	`NCT06073184` - Weight-loss Drug for Fertility-Sparing Treatment of Atypical Hyperplasia and Grade 1 Cancer of the Endometrium	Phase 2
Terminated	`NCT02907073` - Positron Emission Tomography (PET) Imaging Studies With NIS Reporter	Phase 1/Phase 2
Completed	`NCT02549989` - Study of LY3023414 for the Treatment of Recurrent or Persistent Endometrial Cancer	Phase 2