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
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
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label
Identification of maximum tolerated dose
up to 4 years
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
TCD11742
NCT01357330
May 2011
July 2012
Name | Location |
---|---|
Investigational Site Number 840002 | Boston, Massachusetts 02114 |
Investigational Site Number 840001 | Boston, Massachusetts 02114 |
Investigational Site Number 840003 | Nashville, Tennessee 37203 |