Safety and Pharmacokinetics of SAR245408 Daily Oral in Patients With Solid Tumors

NCT01392924 | Completed Phase 1

• 2 other identifiers: TED11883U1111-1118-9727
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objective: \- To confirm safety and tolerability of global recommended phase three dose (RPTD) of SAR245408 tablets when administered on continuous once daily dosing (CDD) in patients with solid tumors. Secondary Objectives:

• To evaluate the plasma pharmacokinetics (PK) of daily oral administration of SAR245408 in CDD treatment schedule in patients with solid tumors.
• To gather preliminary efficacy data after repeated administration of SAR245408 in patients with solid tumors.

Conditions

Neoplasm Malignant

Outcome Measures

Primary Outcomes (1)

• Dose limiting toxicity in cycle 1

  4 weeks

Secondary Outcomes (9)

• Number of treatment emergent adverse events

  28 days after the last dosing

• Number of serious adverse events

  28 days after the last dosing

• Number of abnormality of laboratory test as graded by National Cancer Institute-Common Toxicity Criteria

  28 days after the last dosing

• Pharmacokinetics (Cmax) of SAR245408

  an expected average of 3 months

• Pharmacokinetics (tmax) of SAR245408

  an expected average of 3 months

Study Arms (1)

SAR245408

EXPERIMENTAL

single cohort: SAR245408 administered once daily

Drug: SAR245408

Interventions

SAR245408 DRUG

Pharmaceutical form: tablet Route of administration: oral

SAR245408

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically confirmed solid tumor that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no known therapies to prolong survival.
• Before any study-specific procedure, the appropriate Institutional Review Board (IRB) approved written informed consent must be obtained. Second informed consent must be obtained before the patient starts the Treatment Extension Period (Cycle 2 and after).
• Measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) criteria.

You may not qualify if:

• \< 20 years old.
• Eastern Cooperative Oncology Group (ECOG) performance status \> 2.
• Incapable of understanding or complying with the protocol or has not signed the informed consent document.
• Unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
• Inadequate organ or bone marrow function.
• Prothrombin time (PT)/International Normalized Ratio (INR) and/or partial thromboplastin time (PTT) test results at screening that are above 1.3 × the laboratory upper limit of normal (ULN).
• Baseline corrected QT interval (QTc) \> 460 ms.
• Sexually active (males and females) who do not agree to use medically acceptable methods of contraception during the course of the study and for 3 months following discontinuation of study drug. Female patients of childbearing potential must have a negative pregnancy test at screening.
• Pregnant or breastfeeding.
• Has not tolerated previous treatment with other phosphatidylinositol 3-kinase (PI3K) inhibitor, or has been treated with SAR245408.
• Not recovered from all previous therapies (i.e. radiation, surgery, or medication)
• Currently receiving anticoagulation with therapeutic doses of warfarin (low-dose warfarin ≤ 1mg/day is permitted).
• Primary brain tumor or brain metastasis are considered eligible if the patient has not received radiation therapy for brain metastasis within 2 weeks of enrollment and has been on a stable dose of steroids for 2 or more weeks.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (including cytomegalovirus, Epstein-Barr virus, toxoplasmosis, and hepatitis B and C), symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• Known to be positive for the human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Sanofi: lead

Study Sites (2)

Investigational Site Number 392002

Kobe, Japan

Location

Investigational Site Number 392001

Nagoya, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

XL147

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 13, 2011
• Study Start: August 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: November 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

JP (2)