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XL147

Phase 2

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

XL147 development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jun 2008

XL147 target and mechanism

ModalitySmall molecule

Also known as XL147 (SAR245408)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials6
Total Enrollment386

FDA Designations

No designations recorded

XL147 clinical trials

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 studied in oncology for breast cancer, endometrial cancer, and other advanced solid tumors. Clinical trials have evaluated it both as a single agent and in combinations, including with letrozole in breast cancer, with trastuzumab or paclitaxel plus trastuzumab in metastatic breast cancer, and with paclitaxel and carboplatin in solid tumors.

Who is developing XL147?

XL147 is developed by Sanofi, which trades on the New York Stock Exchange under the ticker SNY. The compound originated at Exelixis and is also identified by the code SAR245408 in Sanofi's development nomenclature.

What phase is XL147 in?

XL147 is in clinical development. Its trials span Phase 1 and Phase 2, and the program is listed at Phase 1 overall. All four recorded studies are completed, with no active trials currently listed, and the drug is investigational rather than approved.

What clinical trials is XL147 in?

Four completed trials are registered for XL147. NCT01082068 tested XL147 or XL765 with letrozole in breast cancer, NCT01042925 tested XL147 with trastuzumab or paclitaxel plus trastuzumab in metastatic breast cancer, NCT01013324 studied advanced or recurrent endometrial carcinoma, and NCT00756847 combined XL147 with paclitaxel and carboplatin in solid tumors.

Is XL147 the same as SAR245408?

Yes. XL147 and SAR245408 refer to the same investigational compound. XL147 was the original Exelixis designation, and SAR245408 is the Sanofi code used after Sanofi took over development, so search results and trial records under either name describe the same drug.

How many patients have been enrolled in XL147 trials?

Across the four completed studies, 233 patients have been enrolled in XL147 clinical trials. Enrollment ranged from 42 participants in the metastatic breast cancer study to 72 in the breast cancer combination study with letrozole, and the trials were conducted in the United States, France, Spain, and Belgium.