A Phase 1 Dose Escalation Study of Combination Therapy With Oral SAR245408 (XL147) and Oral MSC1936369B in Patients With Locally Advanced or Metastatic Solid Tumors
Overview
- Phase
- Phase 1
- Intervention
- SAR245408 (XL147)
- Conditions
- Solid Tumors
- Sponsor
- Sanofi
- Enrollment
- 18
- Locations
- 3
- Primary Endpoint
- Identification of maximum tolerated dose
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Dose Escalation
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)
Intervention: SAR245408 (XL147)
Dose Escalation
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)
Intervention: MSC1936369B
Outcomes
Primary Outcomes
Identification of maximum tolerated dose
Time Frame: up to 4 years
Secondary Outcomes
- 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: Cmax(up to 4 years)
- Pharmakokinetic parameters of SAR245408: Tmax(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)