A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/8/2014 |
| Start Date: | June 2012 |
| End Date: | October 2014 |
| Contact: | For site information, send an email with site number to |
| Email: | Contact-Us@sanofi.com |
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
Primary Objective:
- To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a
day in patients with solid tumors or lymphoma.
Secondary Objectives:
- To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or
twice a day in patients with solid tumors or lymphoma.
- To evaluate the effect of food on blood levels of SAR245409 after administration of
SAR245409 tablets in patients with solid tumors or lymphoma.
- To evaluate the effect of SAR245409 on the body after administration of SAR245409
tablets once or twice a day in patients with solid tumors or lymphoma.
- To obtain information on how SAR245409 administered once or twice a day to patients
with solid tumors or lymphoma affect disease symptoms and study treatment side effects
as reported by the patients on a questionnaire.
- To explore the antitumor activity of SAR245409 tablets administered once or twice a day
to patients with solid tumors or lymphoma.
- To evaluate the safety and tolerability of SAR245409 tablets administered once or twice a
day in patients with solid tumors or lymphoma.
Secondary Objectives:
- To evaluate blood levels of SAR245409 after administration of SAR245409 tablets once or
twice a day in patients with solid tumors or lymphoma.
- To evaluate the effect of food on blood levels of SAR245409 after administration of
SAR245409 tablets in patients with solid tumors or lymphoma.
- To evaluate the effect of SAR245409 on the body after administration of SAR245409
tablets once or twice a day in patients with solid tumors or lymphoma.
- To obtain information on how SAR245409 administered once or twice a day to patients
with solid tumors or lymphoma affect disease symptoms and study treatment side effects
as reported by the patients on a questionnaire.
- To explore the antitumor activity of SAR245409 tablets administered once or twice a day
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).
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 :
- 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.
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