A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma
This study is currently recruiting participants.
Verified February 2013 by Sanofi
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01596270
First received: May 9, 2012
Last updated: February 28, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Neoplasm Malignant |
Drug: SAR245409 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Dose Limiting Toxicities [ Time Frame: Up to Day 28 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Number of patients with treatment-emergent adverse events [ Time Frame: From first dose of SAR245409 until 30 days after the last dose ] [ Designated as safety issue: Yes ]
- Maximum SAR245409 plasma concentration [ Time Frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
- Area under the SAR245409 plasma concentration versus time curve [ Time Frame: Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1 ] [ Designated as safety issue: No ]
- Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing [ Time Frame: Days 1, 2, 3, and 4 of the food interaction period ] [ Designated as safety issue: No ]
- Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing [ Time Frame: Days 1, 2, 3, and 4 of the food interaction period ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Once daily dosing
escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose
|
Drug: SAR245409
Pharmaceutical form: tablet Route of administration: oral
|
|
Experimental: Twice daily dosing
escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose
|
Drug: SAR245409
Pharmaceutical form: tablet Route of administration: oral
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01596270
Contacts
| Contact: For site information, send an email with site number to | Contact-Us@sanofi.com |
Locations
| United States, Michigan | |
| Investigational Site Number 840001 | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Investigational Site Number 840002 | Recruiting |
| New Brunswick, New Jersey, United States, 08903 | |
| United States, Texas | |
| Investigational Site Number 840003 | Recruiting |
| Dallas, Texas, United States, 75230 | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
More Information
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT01596270 History of Changes |
| Other Study ID Numbers: | TED12471, U1111-1123-1488 |
| Study First Received: | May 9, 2012 |
| Last Updated: | February 28, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Neoplasms Lymphoma Neoplasms by Histologic Type Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013