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A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.

Phase 1
20 Years
Not Enrolling
Advance Solid Tumors

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Trial Information

A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.

The duration of the study for each patient will include an up to 4-week screening phase,
21-day study cycle(s), followed by a 30 day follow-up.

Inclusion Criteria

Inclusion criteria:

- Histologically or cytologically documented advanced solid tumor that was refractory to
standard therapy or for which no standard therapy is available

Exclusion criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of ≥2

- Known hematological malignancies

- Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive
of but not limited to surgery, radiation, and corticosteroids

- Myocardial infarction within 6 months of study Day 1, unstable angina, congestive
heart failure with New York Heart Association >class II, uncontrolled hypertension

- Active human immunodeficiency virus infection, hepatitis C virus, or chronic
hepatitis B infection

- Major surgery within 28 days of study Day 1

- Not recovered from all previous therapies (i.e. radiation, surgery, and medications)

- Adverse events related to previous therapies must be Common Terminology Criteria for
Adverse Events (CTCAE) grade ≤ 1 (except alopecia) at screening or returned to the
subject's baseline prior to their most recent previous therapy

- Inadequate organ and bone marrow function Radiation therapy within 14 days of study
Day 1

- Chemotherapy or antibody therapy for treatment of underlying malignancy within 21
days of study Day 1

- Concurrent or prior (within 7 days of study Day 1) anticoagulation therapy

- Currently enrolled or was enrolled within 30 days of completing other investigational
drug study, or receiving other investigational agent not approved for any indications

- Subject who had been previously enrolled in this study . Not available for follow-up

- Any kind of disorder that compromised the ability of the subject to give written
informed consent and/or comply with the study procedures

- Patient who is judged by the investigator as not suitable for participation in the

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, Primary Purpose: Treatment

Outcome Measure:

Dose Limiting Toxicity in cycle 1

Outcome Time Frame:

3 Weeks

Safety Issue:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

September 2010

Completion Date:

February 2013

Related Keywords:

  • Advance Solid Tumors
  • Neoplasms