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
18 Years
N/A
Both
Neoplasm Malignant
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 840002 | Newark, New Jersey 07103 |
| Investigational Site Number 840001 | Detroit, Michigan 48201 |
| Investigational Site Number 840003 | Dallas, Texas 75230 |
