Recent Updates
Recently added Catalysts

XL765

Phase 1

Cancer | Small molecule | Oncology |Sanofi|Last Updated: May 30, 2013

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials2
Total Enrollment163

FDA Designations

No designations recorded

Clinical trial landscape

XL765 · 4 trials · 7 indications

Phase 1 4
NCT01240460Exploratory Study of XL765 (SAR245409) or XL147 (SAR245408) in Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical ResectionGlioblastoma
COMPLETED40 Analytics
NCT00704080A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant GliomasMixed Gliomas
COMPLETED54 Analytics
NCT00777699Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid TumorsCancer
COMPLETED80 Analytics
NCT00485719Study of the Safety and Pharmacokinetics of XL765 (SAR245409) in Adults With Solid TumorsCancer
COMPLETED83 Analytics
PHASE1COMPLETED
Exploratory Study of XL765 (SAR245409) or XL147 (SAR245408) in Subjects With Recurrent Glioblastoma Who Are Candidates for Surgical Resection
Glioblastoma
NCT0124046040
Unlock trial analytics
PHASE1COMPLETED
A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas
Mixed Gliomas
NCT0070408054
Unlock trial analytics
PHASE1COMPLETED
Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors
Cancer
NCT0077769980
Unlock trial analytics
PHASE1COMPLETED
Study of the Safety and Pharmacokinetics of XL765 (SAR245409) in Adults With Solid Tumors
Cancer
NCT0048571983
Unlock trial analytics

Study Endpoints

Primary Endpoints

To explore the biological effect of XL765 and XL147 measured by modulation of PI3K/ mTOR pathway readouts in GB tumor tissue
Assessed between 10 and 28 days after initiation of study drug
Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with temozolomide in subjects with anaplastic gliomas or glioblastoma currently stable on a maintenance temozolomide dose
Assessed at each visit/periodic visits
Safety, tolerability, and maximum tolerated dose of XL765 administered in combination with erlotinib
Assessed during periodic visits
Safety, tolerability, and maximum tolerated dose (MTD) of daily oral administration of XL765 in two treatment schedules
Assessed at each visit/periodic visits

Secondary Endpoints

To examine the safety profile of daily oral administration of XL765 and XL147 in subjects with recurrent GB
Assessed at every visit to the study clinic for the duration of subject's treatment
To determine the levels of XL765 and XL147 in plasma and GB tumor tissue
Assessed at periodic visits between 10 and 28 days after initiation of study drug for the duration of subject's treatment
To assess the anti-proliferative and pro-apoptotic effects of XL765 and XL147 on tumor cells
Assessed at periodic visits to the study clinic for the duration of subject's treatment
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTwice-daily dosing (every 12 hours) XL765
2EXPERIMENTALOnce-daily dosing XL147
3EXPERIMENTALOnce-daily dosing XL765

Interventions

NameTypeDescription
XL765 (SAR245409)DRUGSupplied as 10-mg and/or 50-mg capsules
XL147 (SAR245408)DRUGSupplied as 100-mg, 150-mg and/or 200-mg tablets
TemozolomideDRUGCapsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days
erlotinibDRUGTablets supplied in 25-mg, 100-mg, and 150-mg strengths; daily dosing
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. The subject has histologically confirmed diagnosis of primary GB for which the subject has received prior treatment, including radiation and/or chemotherapy, and will be undergoing a second surgical resection. 2. The subject has available archival tumor tissue from the time o...

Countries:United StatesSpain
Unlock Eligibility Criteria

Competitive Landscape -Cancer 5 trials

CompanyTickerTrialsLead PhaseDrugs
GE Healthcare Technologies Inc.GEHC1PHASE1GEH200520/ GEH200521- Part A
Zimmer Biomet Holdings, Inc.ZBH1 - Undisclosed
Ascentage Pharma Group International Unsponsored ADRAAPG1PHASE1Olverembatinib
Unlock Competitive Intelligence

Frequently asked questions about XL765

What is XL765 used for?

XL765 is an investigational small molecule being studied for the treatment of cancer, including mixed gliomas, glioblastoma, and other solid tumors. It is being developed by Sanofi (SNY) and is currently in Phase 1 clinical development.

What does XL765 target?

XL765 is a small molecule that targets PI3K and mTOR pathways. It is being studied in oncology for its potential to inhibit these signaling pathways involved in tumor growth.

Who makes XL765?

XL765 is being developed by Sanofi, a pharmaceutical company traded on the stock exchange under the ticker SNY. It is an investigational drug currently in Phase 1 clinical trials.

What phase is XL765 in?

XL765 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All clinical trials for XL765 have been completed.

What clinical trials is XL765 in?

XL765 has been studied in several Phase 1 clinical trials, including NCT00485719 for solid tumors, NCT00704080 for malignant gliomas, NCT00777699 for solid tumors and non-small cell lung cancer, and NCT01240460 for recurrent glioblastoma.

Is XL765 the same as SAR245409?

Yes, XL765 is also known as SAR245409. In clinical trials, it is referred to by both names, such as in the study of XL765 (SAR245409) in adults with solid tumors.