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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

Phase 1
18 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

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

Inclusion Criteria

Inclusion criteria:

Patient with advanced solid tumors for which there is no approved or curative therapy:

- has any advanced solid tumor with diagnosed alteration in 1 or more genes of the
PI3K, and mitogen-activated protein kinase (MAPK) pathways and/or

- has a histologically or cytologically confirmed diagnosis of 1 of the following solid
tumors: pancreatic, thyroid, colorectal, non-small cell lung, endometrial, renal,
breast, ovarian carcinoma and melanoma

Exclusion criteria:

The patient has previously been treated with a PI3K inhibitor or a Mitogen-activated
protein extracellular signal-regulated kinase (MEK) inhibitor

The patient has received:

- Chemotherapy, immunotherapy, hormonal therapy, biologic therapy, or any other
anticancer therapy within 28 days or 5 half lives for noncytotoxics (whichever is
shorter) of Day 1 of trial drug treatment (6 weeks for nitrosureas or mitomycin C)

- Any investigational agent within 28 days of Day 1 of trial drug treatment The patient
is currently receiving anticoagulation therapy with therapeutic doses of warfarin
(low-dose warfarin ≤1 mg/day, heparin, and low-molecular weight heparins are
permitted) History of central nervous system metastases The patient has had
congestive heart failure, unstable angina, a myocardial infarction, cardiac
conduction abnormality or pacemaker or a stroke within 3 months of entering the
study. The patient has retinal degenerative disease (hereditary retinal degeneration
or age-related macular degeneration), history of uveitis, or history of retinal vein
occlusion, or has medically relevant abnormalities identified on screening
ophthalmologic examination.

The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

Identification of maximum tolerated dose

Outcome Time Frame:

up to 4 years

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2011

Completion Date:

July 2012

Related Keywords:

  • Solid Tumors
  • locally advanced or metastatic
  • Neoplasms



Investigational Site Number 840002Boston, Massachusetts  02114
Investigational Site Number 840001Boston, Massachusetts  02114
Investigational Site Number 840003Nashville, Tennessee  37203