Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid Tumors

Phase 1

Completed

• Conditions: Solid Tumors
• Interventions: Drug: SAR245408 (XL147); Drug: MSC1936369B

• Registration Number: NCT01357330
• Lead Sponsor: Sanofi

Brief Summary

Primary Objective:

- To determine the maximum tolerated dose(s) (MTD) and the recommended Phase 2 dose(s) (RP2D) of SAR245408 and MSC1936369B when combined in adult subjects with locally advanced or metastatic solid tumors.

Secondary Objective:

* To characterize the safety and tolerability of SAR245408 and MSC1936369B combination therapy administered orally to adult patients with locally advanced or metastatic solid tumors

* To evaluate the pharmacokinetic (PK) profile of SAR245408 and MSC1936369B when used in combination

* To evaluate the pharmacodynamic (PD) effect of the SAR245408/MSC1936369B combination by assessing target and pathway inhibition

Detailed Description

The duration of the study will include a period for screening of up to a maximum of 28 days, a pretreatment evaluation period of up to 5 days, the on-treatment period, followed by a minimum of 30-day follow-up after the last study drug administration.

The patient may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal.

The study will have 2 parts:

* Part one - Dose Escalation

* Part Two - Expansion. At the defined maximum tolerated doses (MTD(s), additional patients will be enrolled to collect safety, Pharmacokinetic, and Pharmacodynamic data

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-16
• Study First Submitted QC: 2011-05-19
• Study First Posted: 2011-05-20
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-08
• Last Update Submitted: 2016-03-31
• Last Update Posted: 2016-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dose Escalation	SAR245408 (XL147)	Dose escalation phase The starting dose of SAR245408 will be 25-mg once daily (up to 200-mg). The starting dose of MSC1936369B will be 15- mg once daily (up to 90-mg)
Dose Escalation	MSC1936369B	Dose escalation phase The starting dose of SAR245408 will be 25-mg once daily (up to 200-mg). The starting dose of MSC1936369B will be 15- mg once daily (up to 90-mg)

Primary Outcome Measures

Name	Time	Method
Identification of maximum tolerated dose	up to 4 years

Secondary Outcome Measures

Name	Time	Method
Number of participants with treatment emergent adverse events	up to 4 years
Pharmakokinetic parameters of MSC1936369B: AUCι	up to 4 years
Pharmakokinetic parameters of SAR245408: Tmax	up to 4 years
Pharmakokinetic parameters of SAR245408: Cmax	up to 4 years
Pharmakokinetic parameters of SAR245408:AUCι	up to 4 years
Pharmakokinetic parameters of MSC1936369B: Cmax	up to 4 years
Pharmakokinetic parameters of MSC1936369B: Tmax	up to 4 years

Trial Locations

Locations (3)

Investigational Site Number 840001; 🇺🇸 Boston, Massachusetts, United States

Investigational Site Number 840002; 🇺🇸 Boston, Massachusetts, United States

Investigational Site Number 840003; 🇺🇸 Nashville, Tennessee, United States