A Study of the Safety and Pharmacokinetics of SAR245409 Tablets in Patients With Solid Tumors or Lymphoma

NCT01596270 | Completed Phase 1

• 2 other identifiers: TED12471U1111-1123-1488
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicities

  Up to Day 28

Secondary Outcomes (5)

• Number of patients with treatment-emergent adverse events

  From first dose of SAR245409 until 30 days after the last dose

• Maximum SAR245409 plasma concentration

  Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1

• Area under the SAR245409 plasma concentration versus time curve

  Cycle 1 Days 1, 2, 8, 15, and 28, and Cycle 2 Day 1

• Ratio of maximum SAR245409 plasma concentration between fed and fasted dosing

  Days 1, 2, 3, and 4 of the food interaction period

• Ratio of area under the SAR245409 plasma concentration versus time curve between fed and fasted dosing

  Days 1, 2, 3, and 4 of the food interaction period

Study Arms (2)

Once daily dosing

EXPERIMENTAL

escalating doses, once daily dosing every day, no eating for 2 hours prior and 1 hour after dose

Drug: SAR245409

Twice daily dosing

EXPERIMENTAL

escalating doses, twice daily dosing every day, no eating for 2 hours prior and 1 hour after dose

Drug: SAR245409

Interventions

SAR245409 DRUG

Pharmaceutical form: tablet Route of administration: oral

Once daily dosing; Twice daily dosing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (3)

Investigational Site Number 840001

Detroit, Michigan, 48201, United States

Location

Investigational Site Number 840002

New Brunswick, New Jersey, 08903, United States

Location

Investigational Site Number 840003

Dallas, Texas, 75230, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

XL765

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: May 10, 2012
• Study Start: June 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 28, 2020

Record last verified: 2014-10

Locations

US (3)