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NCT Number: NCT01213381

Safety and Pharmacokinetics of SAR240550 (BSI-201) Twice Weekly in Patients With Advanced Solid Tumors

Primary Objective:

- To determine a dose of SAR240550 to be further studied in combination with chemotherapy regimens

Secondary Objectives:

* To determine the dose limiting toxicity (DLT) of SAR240550 and SAR240550 in combination with chemotherapy regimen (gemcitabine and carboplatin * To assess safety profiles: significant laboratory changes and adverse events (AEs) * To make a preliminary assessment of antitumor effect in study subjects per Response Evaluation Criteria in Solid Tumors (RECIST) with measurable disease * To characterize SAR240550 and metabolites, 4-iodo-3-amino benzamide (IABM) and 4-iodo-3-amino-benzoic acid (IABA), pharmacokinetics * To collect blood samples for glutathione S-transferase (GST) genotypes at baseline)

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

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Key information

Conditions

Advance Solid Tumors

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Sanofi-Aventis Investigational Site Number 392001, Kobe, Japan

Loading trial locations.

About this study

The duration of the study for each patient will include an up to 4-week screening phase, 21-day study cycle(s), followed by a 30 day follow-up.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically or cytologically documented advanced solid tumor that was refractory to standard therapy or for which no standard therapy is available

Exclusion criteria

  • Eastern Cooperative Oncology Group (ECOG) performance status of ≥2
  • Known hematological malignancies
  • Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
  • Myocardial infarction within 6 months of study Day 1, unstable angina, congestive heart failure with New York Heart Association >class II, uncontrolled hypertension
  • Active human immunodeficiency virus infection, hepatitis C virus, or chronic hepatitis B infection
  • Major surgery within 28 days of study Day 1
  • Not recovered from all previous therapies (i.e. radiation, surgery, and medications)
  • Adverse events related to previous therapies must be Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1 (except alopecia) at screening or returned to the subject's baseline prior to their most recent previous therapy
  • Inadequate organ and bone marrow function Radiation therapy within 14 days of study Day 1
  • Chemotherapy or antibody therapy for treatment of underlying malignancy within 21 days of study Day 1
  • Concurrent or prior (within 7 days of study Day 1) anticoagulation therapy
  • Currently enrolled or was enrolled within 30 days of completing other investigational drug study, or receiving other investigational agent not approved for any indications
  • Subject who had been previously enrolled in this study . Not available for follow-up assessment
  • Any kind of disorder that compromised the ability of the subject to give written informed consent and/or comply with the study procedures
  • Patient who is judged by the investigator as not suitable for participation in the study

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

Treatment and study plan

Iniparib (SAR240550 - BSI-201)

Drug

Pharmaceutical form:sterile aqueous solution

Route of administration: intravenous

Gemcitabine

Drug

Pharmaceutical form:sterile aqueous solution

Route of administration: intravenous

carboplatin

Drug

Pharmaceutical form:sterile aqueous solution

Route of administration: intravenous

Primary outcomes

  1. Dose Limiting Toxicity in cycle 1

    Time frame: 3 Weeks

Secondary outcomes

  1. Efficacy assessment as tumor response defined by Response Evaluation Criteria in Solid Tumors (RECIST)

    Time frame: 30 days after the last injection

  2. Safety based on clinical and laboratory tests and Adverse Events (AEs)

    Time frame: 30 days after the last injection

  3. Pharmacokinetics of SAR240550

    Time frame: Cycle 1 and Cycle 2

  4. Pharmacodynamics of SAR240550

    Time frame: Cycle1, Cycle 2 and 30 days after the last injection

  5. Pharmacogenomic analysis of glutathione S-transferase (GST) genotypes

    Time frame: Cycle 1

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase I Study Evaluating the Safety and Pharmacokinetics of SAR240550 Administered Twice Weekly in Patients With Advanced Solid Tumors.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Oct 4, 2010
Registry last updated
May 24, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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