NCT01673737

A Phase I/Ib Trial for the Evaluation of SAR260301 in Monotherapy or in Combination With Vemurafenib in Patients With Various Advanced Cancer

A Phase I/Ib Study for the Evaluation of SAR260301, Administered Orally in Monotherapy in Patients With Advanced Solid Tumors or Lymphomas, and in Combination With Vemurafenib in Patients With Unresectable / Metastatic BRAF-mutated Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Sanofi · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: Part A - Monotherapy: \- To determine the maximum tolerated dose (MTD) of SAR260301 administered as monotherapy and either on a once or twice daily schedule, to patients with advanced solid tumors or lymphomas. Part B - Combination: \- To determine the maximum tolerated dose (MTD) of SAR260301 administered in combination with the recommended standard dosage of vemurafenib to patients with unresectable / metastatic v-raf murine sarcoma viral oncogene homolog B1 (BRAF)-mutated melanoma. Secondary Objectives: * To characterize the overall safety and tolerability profile of SAR260301 administered as monotherapy (Part A) and in combination with vemurafenib (Part B). * To characterize the pharmacokinetic (PK) profile of SAR260301 administered as monotherapy (Part A) and in combination with vemurafenib (Part B) as well as vemurafenib PK in combination with SAR260301 (Part B) * To evaluate food effect on SAR260301 PK (Part A) * To assess preliminary antitumor activity according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria). * To assess preliminary antitumor activity using volumetric computed tomography (CT) or magnetic resonance imaging(MRI) * To evaluate the pharmacodynamic (PD) effects of SAR260301 on blood and tumor. * To evaluate PK/PD relationships. * To identify the recommended phase 2 dose of SAR260301 in combination with vemurafenib (RP2D) (Part B only) * To assess potential induction effect of SAR260301 on cytochrome P450 (CYP) isoenzyme 3A (CYP3A) (Part A)

Detailed description

Study duration for one patient will include a period for inclusion (screening period) of up to 4 weeks, a treatment period of at least 4 weeks, and a end-of-study visit at 30 days following the last administration of study drug. The patient may continue treatment until disease progression, unacceptable toxicity or willingness to stop, followed by a minimum of 30-days follow-up.

Conditions

• Neoplasm Malignant

Interventions

Type	Name	Description
DRUG	SAR260301	Pharmaceutical form: film-coated tablets Route of administration: oral
DRUG	Vemurafenib	Pharmaceutical form: film-coated tablets Route of administration: oral

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2012-08-28
• Last updated: 2015-04-10

Locations

4 sites across 2 countries: United States, Canada