Know Cancer

or
forgot password

Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Adult Patients With DS6-positive and Refractory Solid Tumors


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Neoplasm Malignant

Thank you

Trial Information

Dose Escalation, Safety and Pharmacokinetic, First in Man Study, of SAR566658 Administered as a Single Agent by Intravenous Infusion Every 3 Weeks in Adult Patients With DS6-positive and Refractory Solid Tumors


The study consists in a period for screening (maximum length of 3 weeks), a treatment phase
with 21-day study treatment cycles. Patients may continue treatment until disease
progression, unacceptable toxicity, or willingness to stop. There will be a 30-day follow-up
visit after the last dose of study treatment administration.

Inclusion Criteria


Inclusion criteria:

- Diagnosis of DS6-positive solid tumors defined as moderate to intense membrane staining
of ≥ than 30% of tumor cells) with measurable and/or non-measurable disease for which no
standard therapy is available

Exclusion criteria :

- Eastern Cooperative Oncology Group performance status > or = 2

- Any serious active disease or co-morbid condition, which, in the opinion of the
investigator, may interfere with the safety or the compliance with the study

- Poor bone marrow reserve

- Poor liver and renal function

- Pregnant or breast-feeding woman

- No use of effective birth control methods, when applicable

- No resolution of any specific toxicities related to any prior anti-cancer therapy to
Grade < 1 according to the NCI--CTCAE (National Cancer Institute - Common Toxicity
Criteria for Adverse Events) version 4.03 grade scaling

- Wash out period of less than 3 weeks from previous antitumor therapy or any
investigational treatment, (and less than 6 weeks in case of prior nitroso-urea and
or mitomycin C treatment). Patients will be eligible if hormonotherapy (ie, for
breast tumors) is discontinued before first Investigational Product administration

- Wash out period of less than 1 week from last palliative dose of radiotherapy

- Patients with respiratory insufficiency defined by a decrease more than 25% compared
to theoretical baseline pulmonary volumes and theoretical baseline DLCO (Diffusing
capacity of the Lung for Carbon monoxide)

- Any lung radiotherapy in patient's cancer history

- Patients with abnormal cardiac function defined by a Left Ventricular Ejection
Fraction < 50%

- Patients with previous history of acute cardiac failure

- Patients with previous history and/or unresolved corneal disorders

- Known intolerance to infused protein products or maytansinoids

- Patients with previous history or active interstitial lung disease or pulmonary
fibrosis

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Assessment of investigational product (IP) related dose limiting toxicities (DLTs) observed at first cycle

Outcome Time Frame:

3 weeks

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TED10499

NCT ID:

NCT01156870

Start Date:

September 2010

Completion Date:

April 2015

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms

Name

Location

Investigational Site Number 840001San Antonio, Texas  78229
Investigational Site Number 840002Cincinnati, Ohio  45267-0542