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XL147

Phase 2

Endometrial Cancer | Small molecule | Oncology |Sanofi|Last Updated: Jun 3, 2016

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment67

FDA Designations

No designations recorded

Clinical trial landscape

XL147 · 6 trials · 9 indications

Phase 2 1Phase 1 5
NCT01013324Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial CarcinomaEndometrial Cancer
COMPLETED67 Analytics
PHASE2COMPLETED
Study of XL147 (SAR245408) in Advanced or Recurrent Endometrial Carcinoma
Endometrial CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy as defined by overall response rate and progression-free survival (PFS) at 6 months
every 8-10 weeks
Safety of XL147 in the EC population
scheduled evaluations every 2-4 weeks
Safety and tolerability of XL147 and letrozole and XL765 and letrozole
at weekly and bi-weekly study visits
In Phase 1, to determine the maximum tolerated dose of XL147 in combination with letrozole and of XL765 in combination with letrozole
assessed by weekly study visits
In Phase 2, to evaluate progression-free survival at 3 months
tumor assessments at Week 13 and every 8 weeks thereafter
Safety and tolerability of XL147 in combination with trastuzumab and in combination with trastuzumab and paclitaxel
safety assessments at weekly study visits
In Phase 1, the maximum tolerated dose (MTD) of XL147 when administered in combination with trastuzumab and in combination with trastuzumab and paclitaxel
assessed by weekly study visits
In Phase 2, objective tumor response
every 6 weeks
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 175 mg/m2) and carboplatin in subjects with advanced solid tumors
Assessed at periodic visits
To evaluate the safety, tolerability, and MTD of XL147 administered in combination with paclitaxel (at doses up to 225 mg/m2) and carboplatin in subjects with NSCLC
Assessed at periodic visits
Safety, tolerability, and maximum tolerated dose of XL147 administered in combination with erlotinib
Assessed during periodic visits
Safety, tolerability, and maximum tolerated dose of oral administration of two formulations of XL147 in two treatment schedules
Assessed at each visit/periodic visits
Safety and tolerability of oral dosing with XL147 capsules in subjects with lymphoma, and of XL147 capsules and tablets in subjects with solid tumors
Assessed at periodic study visits

Secondary Endpoints

Duration of response and PFS
every 8-10 weeks
Characterize pharmacokinetic and pharmacodynamic profiles of XL147
at periodic visits not less than every 4 weeks
In Phase 2, to assess other clinical benefit and efficacy parameters
tumor assessments at Week 13 and every 8 weeks thereafter
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single ArmEXPERIMENTALAll subjects will receive single-agent XL147 dosed daily
Arm 1EXPERIMENTALXL147 (SAR245408) + letrozole
Arm 2EXPERIMENTALXL765 + letrozole
1EXPERIMENTAL -
2EXPERIMENTALContinuous daily dosing
3EXPERIMENTALContinuous daily dosing

Interventions

NameTypeDescription
XL147 (SAR245408)DRUGdosed as capsules taken orally daily
XL765 (SAR245409)DRUGgiven orally twice daily as capsules
letrozole (Femara)DRUGgiven orally once daily as tablets
trastuzumabBIOLOGICALadministered by IV once every 3 weeks
paclitaxelDRUGadministered by IV once every week
XL147 (SAR245408),DRUGGelatin capsules supplied in 25- and 100-mg strengths; daily dosing
carboplatinDRUGIntravenous injection dosed once every three weeks
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
SexFEMALE
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * The subject has a histologically confirmed diagnosis of EC (endometrioid, serous, clear cell adenocarcinoma, adenosquamous carcinoma, or mixed histology, any grade) that is advanced (ie, persistent, locally advanced) or recurrent, and is incurable by standard therapies and has...

Countries:United StatesBelgiumFranceSpain
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Frequently asked questions about XL147

What is XL147 used for?

XL147 is an investigational small molecule being studied for the treatment of cancer, including endometrial cancer, breast cancer, and non-small cell lung cancer. It was evaluated in clinical trials for solid tumors and lymphoma. XL147 is not approved and remains in clinical development.

What does XL147 target?

XL147 is a small molecule that targets the PI3K pathway. It was studied as a single agent and in combination with other therapies for the treatment of various cancers, including endometrial cancer and non-small cell lung cancer.

Who makes XL147?

XL147 is being developed by Sanofi, a company traded on the stock exchange under the ticker SNY. Sanofi conducted clinical trials to evaluate the safety and efficacy of XL147 in patients with cancer.

What phase is XL147 in?

XL147 has completed Phase 1 and Phase 2 clinical trials. The Phase 2 trial studied XL147 in advanced or recurrent endometrial carcinoma. However, XL147 is still investigational and has not been approved by regulatory authorities.

What clinical trials is XL147 in?

XL147 has been studied in several clinical trials, including NCT00486135, a Phase 1 study in adults with solid tumors or lymphoma; NCT00692640, a Phase 1 study combining XL147 with erlotinib; NCT00756847, a Phase 1 study combining XL147 with paclitaxel and carboplatin; and NCT01013324, a Phase 2 study in endometrial carcinoma.

Is XL147 the same as SAR245408?

Yes, XL147 is also known as SAR245408. Clinical trials for XL147 often list the drug under the name SAR245408, as seen in studies such as NCT00486135 and NCT00692640.