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SAR260301

Phase 1

Neoplasm Malignant | Small molecule | Oncology |Sanofi|Last Updated: Apr 10, 2015

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment75

FDA Designations

No designations recorded

Clinical trial landscape

SAR260301 · 1 trial · 1 indication

Phase 1 1
NCT01673737A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced CancerNeoplasm Malignant
COMPLETED75 Analytics
PHASE1COMPLETED
A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer
Neoplasm MalignantUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximal tolerated dose (MTD) of SAR260301 in monotherapy (Study Part A)
Day 28
Maximal tolerated dose (MTD) of SAR260301 in combination with vemurafenib (Study Part B)
Day 28

Secondary Endpoints

Number of patients with treatment emergent events
Up to 2 years
Assessment of PK parameters for SAR260301 and vemurafenib, including tmax, Cmax, AUC, Rac (Day 28/Day1), half-life, CL, Ctrough
4 weeks
Assessment of PK parameters for SAR260301 including tmax, Cmax, AUC fasting and fed (food effect)(Only part A)
Up to 8 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A MonotherapyEXPERIMENTALDose escalation of daily or twice daily SAR260301 within a 28-day cycle, followed by an expansion phase at the maximal tolerated dose
Part B CombinationEXPERIMENTALDose escalation of twice-daily SAR260301 within a 28-day cycle and in combination with 720 or 960 mg twice daily of Vemurafenib, followed by an expansion phase at the maximal tolerated dose of SAR260301 in combination

Interventions

NameTypeDescription
SAR260301DRUGPharmaceutical form: film-coated tablets Route of administration: oral
VemurafenibDRUGPharmaceutical form: film-coated tablets Route of administration: oral
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Eligibility Criteria

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

Inclusion criteria : * Age ≥18 years old * Locally advanced or metastatic solid tumor disease as well as lymphoma for which no alternative therapy is available (Part A) * Unresectable / metastatic BRAF-mutated melanomas, progressing on BRAF inhibitor after no more than 4 months treatment or with on...

Countries:United StatesCanada
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Frequently asked questions about SAR260301

What is SAR260301 used for?

SAR260301 is an investigational small molecule being studied for the treatment of Neoplasm Malignant, a type of cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved for any use. The drug is being evaluated in patients with various advanced cancers.

Who makes SAR260301?

SAR260301 is being developed by Sanofi, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol SNY. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational oncology drug.

What phase is SAR260301 in?

SAR260301 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is no longer in active clinical trials according to available data.

What clinical trials is SAR260301 in?

SAR260301 has been studied in one clinical trial, identified as NCT01673737. This was a Phase I/Ib trial evaluating SAR260301 as a monotherapy or in combination with vemurafenib in patients with various advanced cancers. The trial was completed and enrolled 75 participants.

Is SAR260301 the same as any other drug?

No alternative names for SAR260301 have been identified. It is a unique investigational compound developed by Sanofi. In clinical trials, it has been studied both alone and in combination with vemurafenib, but it is not known to be the same as any other marketed drug.