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

NCT01673737 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2015-04-10

No results posted yet for this study

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)

Conditions

  • Neoplasm Malignant

Interventions

DRUG

SAR260301

Pharmaceutical form: film-coated tablets Route of administration: oral

DRUG

Vemurafenib

Pharmaceutical form: film-coated tablets Route of administration: oral

Sponsors & Collaborators

Principal Investigators

  • Clinical Sciences & Operations · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-02-28
Completion
2015-02-28

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01673737 on ClinicalTrials.gov