Know Cancer

or
forgot password

A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma


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

Thank you

Trial Information

A Phase 1 Dose-escalation Study of the Safety and Pharmacokinetics of a Tablet Formulation of SAR245409 Administered Daily to Patients With Solid Tumors or Lymphoma


The total study duration per patient will be 58 to 128 days and will include a screening
period (1 to 28 days), a food interaction investigation period (when applicable; 4 to 11
days), two 28-day treatment cycles (56 days), an end-of-treatment visit (within 7 days after
the last SAR245409 administration) and a follow-up visit (within 30 ± 3 days after the last
SAR245409 administration).

Inclusion Criteria


Inclusion criteria :

- Solid tumor that is metastatic or unresectable, or relapsed or refractory lymphoma
(including chronic lymphocytic leukemia/small lymphocytic lymphoma), for which
standard therapies are no longer effective or there are no therapies known to prolong
survival.

- Male or female patient > or = 18 years old.

- Eastern Cooperative Oncology Group Performance Status < or = 1.

- Adequate white blood cells, platelets and haemoglobin.

- Adequate liver and kidney functions.

- Fasting plasma glucose < 160 mg/dL.

- No other malignancy.

- Women of childbearing potential using adequate contraception.

Exclusion criteria:

- History of partial or full gastrectomy.

- Lymphoma involving the gastrointestinal tract.

- Uncontrolled brain metastases or a primary brain tumor.

- Prior treatment with cytotoxic chemotherapy (including investigational agents) or
biologic agents (antibodies, immune modulators, and cytokines) within 4 weeks, or
nitrosoureas or mitomycin C within 6 weeks, before the first dose of study treatment.

- Prior treatment with a small-molecule kinase inhibitor (including investigational
agents) within 2 weeks, or 5 half lives of the drug or active metabolites, whichever
is longer, before the first dose of study treatment.

- Any other investigational therapy within 4 weeks before the first dose of study
treatment.

- Prior anticancer hormonal therapy within 1 week before the first dose of study
treatment.

- Prior radiation therapy within 2 weeks before the first dose of study treatment.

- Intolerance of prior treatment with a PI3K inhibitor.

- Hereditary or acquired immunodeficiency syndrome or HIV (human immunodeficiency
virus) infection.

- Lymphoma patients with positive serologies for Hepatitis B surface antigen (HBsAg) or
anti-Hepatitis C virus (anti-HCV) antibodies.

- Positive serologies for Hepatitis B surface antigen (HBsAg) or anti-Hepatitis C virus
(anti-HCV) antibodies.

- Patient is pregnant or breastfeeding.

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:

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

Outcome Measure:

Dose Limiting Toxicities

Outcome Time Frame:

Up to Day 28

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

TED12471

NCT ID:

NCT01596270

Start Date:

June 2012

Completion Date:

June 2014

Related Keywords:

  • Neoplasm Malignant
  • Neoplasms
  • Lymphoma

Name

Location

Investigational Site Number 840002Newark, New Jersey  07103
Investigational Site Number 840001Detroit, Michigan  48201
Investigational Site Number 840003Dallas, Texas  75230