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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01392924
First received: July 5, 2011
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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.

Condition Intervention Phase
Neoplasm Malignant
Drug: SAR245408
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Dose Escalation Study Evaluating the Safety and Pharmacokinetics of SAR245408 Administered Orally Daily in Patients With Solid Tumors

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Dose limiting toxicity in cycle 1 [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of treatment emergent adverse events [ Time Frame: 28 days after the last dosing ] [ Designated as safety issue: Yes ]
  • Number of serious adverse events [ Time Frame: 28 days after the last dosing ] [ Designated as safety issue: Yes ]
  • Number of abnormality of laboratory test as graded by National Cancer Institute-Common Toxicity Criteria [ Time Frame: 28 days after the last dosing ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics (Cmax) of SAR245408 [ Time Frame: an expected average of 3 months ] [ Designated as safety issue: No ]
    Cycles 1 and 2, and every 4th cycle after Cycle 4

  • Pharmacokinetics (tmax) of SAR245408 [ Time Frame: an expected average of 3 months ] [ Designated as safety issue: No ]
    Cycles 1 and 2, and every 4th cycle after Cycle 4

  • Pharmacokinetics (AUC) of SAR245408 [ Time Frame: an expected average of 3 months ] [ Designated as safety issue: No ]
    Cycles 1 and 2, and every 4th cycle after Cycle 4

  • Pharmacokinetics (accumulation ratio) of SAR245408 [ Time Frame: an expected average of 3 months ] [ Designated as safety issue: No ]
    Cycles 1 and 2, and every 4th cycle after Cycle 4

  • Pharmacokinetics (Ctrough) of SAR245408 [ Time Frame: an expected average of 3 months ] [ Designated as safety issue: No ]
    Cycles 1 and 2, and every 4th cycle after Cycle 4

  • Objective tumor response as defined by RECIST (response evaluation criteria in solid tumors) [ Time Frame: At 8 weeks and every 2 months thereafter ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2011
Estimated Study Completion Date: November 2014
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SAR245408
single cohort: SAR245408 administered once daily
Drug: SAR245408
Pharmaceutical form: tablet Route of administration: oral

Detailed Description:

The duration of the study for 1 patient will include a period for screening up to 28 days, the study treatment period, followed by a 28-day follow-up after the last study drug administration.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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.

Exclusion criteria:

  • < 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)
  • Psychiatric illness/social situation(s) that would limit compliance with study requirements.
  • Allergy or hypersensitivity to components of the SAR245408 formulation.
  • Withdraws consent during the screening (starting from signed informed consent form (ICF))
  • Patient who is judged by the investigator as not suitable for participating in the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01392924

Locations
Japan
Investigational Site Number 392002
Kobe-Shi, Japan
Investigational Site Number 392001
Nagoya-Shi, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01392924     History of Changes
Other Study ID Numbers: TED11883, U1111-1118-9727
Study First Received: July 5, 2011
Last Updated: November 19, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on July 24, 2014