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XL765

Phase 1

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

XL765 target and mechanism

ModalitySmall molecule

Also known as XL765 (SAR245409)

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials4
Total Enrollment257

FDA Designations

No designations recorded

XL765 clinical trials

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
GlioblastomaUnlock trial analytics
PHASE1COMPLETED
A Study of XL765 (SAR245409) in Combination With Temozolomide With and Without Radiation in Adults With Malignant Gliomas
Mixed GliomasUnlock trial analytics
PHASE1COMPLETED
Safety Study of XL765 (SAR245409) in Combination With Erlotinib in Adults With Solid Tumors
CancerUnlock trial analytics
PHASE1COMPLETED
Study of the Safety and Pharmacokinetics of XL765 (SAR245409) in Adults With Solid Tumors
CancerUnlock 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
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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
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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
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Competitive Landscape -Cancer 7 trials

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Frequently asked questions about XL765

What is XL765 used for?

XL765 is an investigational small molecule being studied in oncology for the treatment of cancer, including glioblastoma, mixed gliomas, and other solid tumors. It has been evaluated in Phase 1 clinical trials in adults with recurrent glioblastoma, malignant gliomas, non-small cell lung cancer, and advanced solid tumors.

Who is developing XL765?

XL765 is being developed by Sanofi, which trades under the ticker SNY. The drug is also known as SAR245409.

What phase is XL765 in?

XL765 is in Phase 1 clinical development. All four of its listed trials are Phase 1 studies, and all are completed. The drug is investigational and has not been approved by the FDA.

What clinical trials is XL765 in?

XL765 has been studied in four completed Phase 1 trials: NCT01240460 in recurrent glioblastoma, NCT00777699 in combination with erlotinib in solid tumors and non-small cell lung cancer, NCT00704080 with temozolomide in malignant gliomas, and NCT00485719 in solid tumors.

Is XL765 the same as SAR245409?

Yes, XL765 and SAR245409 are the same drug. SAR245409 is an alternative name for XL765, and both names refer to the same investigational small molecule developed by Sanofi.