Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial

International, Multi-Center, Open-label, Treatment Extension Study of Iniparib as Monotherapy or in Combination Chemotherapeutic Regimens in Cancer Patients Who Have Derived Clinical Benefit From Iniparib Following Completion of a Phase 1, 2 or 3 Parental Study

The purpose of this study is to assess the safety and tolerability of iniparib administered as monotherapy or in combination regimens in patients previously treated with iniparib in a clinical study and who have derived clinical benefit after completion of the parental study's objectives.

Study Overview

• Status: Completed
• Conditions: Solid Tumors
• Intervention / Treatment: Drug: Iniparib (SAR240550/BSI-201); Drug: Carboplatin; Drug: Doxorubicin HCL liposome injection; Drug: Gemcitabine; Drug: Irinotecan; Drug: Paclitaxel; Drug: Topotecan

Detailed Description

The Treatment Extension protocol consists of three time points/periods: the Screening Period (during which assessments are performed to determine whether the patient meets the criteria to participate in the study), the Treatment Period (during which the patient receives treatment with the study drug(s)), and the Post-Treatment Period (during which patients complete an evaluation approximately 30 days after the last dose of study drug). Patients may continue to participate on the Treatment Extension study as long as they meet criteria to continue to receive therapy, tolerate the treatment regimen, do not develop progressive disease (PD), do not discontinue from iniparib, do not withdraw consent, or until iniparib becomes commercially available.

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Investigational Site Number 056002
• Italy
  • Genova, Italy, 16132
    • Investigational Site Number 380002
• Spain
  • Valencia, Spain, 46010
    • Investigational Site Number 724001
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Investigational Site Number 840013
  • California
    • Santa Maria, California, United States, 93454-8903
      • Investigational Site Number 840033
    • Vallejo, California, United States, 94589
      • Investigational Site Number 840046
  • Colorado
    • Denver, Colorado, United States, 80218
      • Investigational Site Number 840008
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Investigational Site Number 840027
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Investigational Site Number 840063
    • Tucker, Georgia, United States, 30084
      • Investigational Site Number 840055
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Investigational Site Number 840039
  • Indiana
    • Indianapolis, Indiana, United States, 46227
      • Investigational Site Number 840012
  • Iowa
    • Sioux City, Iowa, United States, 51105
      • Investigational Site Number 840025
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Investigational Site Number 840030
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Investigational Site Number 840001
  • Minnesota
    • Minneapolis, Minnesota, United States, 55407-3799
      • Investigational Site Number 840006
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • Investigational Site Number 840002
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Investigational Site Number 840059
    • Saint Louis, Missouri, United States, 63141
      • Investigational Site Number 840004
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Investigational Site Number 840022
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
      • Investigational Site Number 840017
  • New York
    • Albany, New York, United States, 12206
      • Investigational Site Number 840010
  • North Carolina
    • Charlotte, North Carolina, United States
      • Investigational Site Number 840015
  • Ohio
    • Cincinnati, Ohio, United States
      • Investigational Site Number 840060
    • Cleveland, Ohio, United States, 44106
      • Investigational Site Number 840043
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Investigational Site Number 840021
  • Tennessee
    • Memphis, Tennessee, United States, 38120-2146
      • Investigational Site Number 840028
  • Texas
    • Austin, Texas, United States, 78731
      • Investigational Site Number 840007
    • El Paso, Texas, United States, 79915
      • Investigational Site Number 840003
    • Plano, Texas, United States, 75075
      • Investigational Site Number 840019
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Investigational Site Number 840005
  • Washington
    • Vancouver, Washington, United States, 98684
      • Investigational Site Number 840009

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria :

• Cancer patients greater than 18 years of age who have completed all assessments required to meet the primary objectives of a parental phase 1, 2 or 3 clinical study of iniparib as monotherapy or in a combination regimen.
• Previously received and are continuing to derive clinical benefit from iniparib, as monotherapy or in combination with chemotherapy, as determined by the treating physician.
• Ongoing treatment with iniparib at time of parental study completion/closure and meet criteria to initiate a subsequent cycle of therapy, as described in the parental study protocol.
• On a stable parental study regimen (at least one cycle for the regimen at the dose/schedule that is to be given in the Treatment Extension study must have been given prior to the patient's discontinuation from the parental study). Signed written informed consent.

Exclusion criteria:

• Patient has not previously participated in any clinical trial of iniparib.
• Patient has evidence of progressive disease while receiving iniparib.
• Patient has another concurrent invasive malignancy (aside from the malignancy for which the patient has received therapy for on the parental protocol).
• Patient has a major medical or co-morbid condition(s) that the investigator believes might compromise safe participation in the study (such as uncontrolled lung, kidney, or liver problems; uncontrolled infection; a history of congestive heart failure; or an electrocardiogram suggesting significant problems with the heart).
• Patient has not recovered to baseline or less than Grade 1 from non-hematologic adverse events related to any anticancer therapy received prior to signing informed consent on the Treatment Extension study, with the exception of hair loss.
• Patient is receiving concurrent treatment with other investigational agents not allowed as part of the combination regimen in the parental study protocol.
• Concurrent anticancer treatment with any agent other than iniparib and any co-administered chemotherapeutic agent(s) specified on the parental study protocol are not permitted throughout the course of the study.
• Patient is receiving concurrent radiation therapy to treat primary disease with curative intent. (Note that palliative radiotherapy is allowed as long as there is no evidence of progressive disease.)
• Patient is unable to comply with the requirements of the study.
• Pregnant or breast-feeding women.
• Women of childbearing potential or men with partners of childbearing potential who are not protected or who are unwilling to use an effective contraceptive method of birth control during the course of the study and for a period of 6 months following the last dose.

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 1; Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions: Drug: Iniparib monotherapy; Drug: Iniparib + gemcitabine + carboplatin; Drug: Iniparib + topotecan; Drug: Iniparib + irinotecan; Drug: Iniparib + paclitaxel; Drug: Iniparib + liposomal doxorubicin + carboplatin

Drug: Iniparib (SAR240550/BSI-201); Pharmaceutical form:Solution Route of administration: Intravenous; Drug: Carboplatin; Pharmaceutical form:Solution Route of administration: Intravenous; Drug: Doxorubicin HCL liposome injection; Pharmaceutical form:Solution Route of administration: Intravenous; Drug: Gemcitabine; Pharmaceutical form:Solution Route of administration: Intravenous; Drug: Irinotecan; Pharmaceutical form:Solution Route of administration: Intravenous; Drug: Paclitaxel; Pharmaceutical form:Solution Route of administration: Intravenous; Drug: Topotecan; Pharmaceutical form:Solution Route of administration: Intravenous

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with incidence of adverse events by NCI-CTCAE version 4.03	Up to 30 days after last treatment dose

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: April 30, 2012
• First Submitted That Met QC Criteria: May 4, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Poly(ADP-ribose) Polymerase Inhibitors; Antibiotics, Antineoplastic; Topoisomerase I Inhibitors; Gemcitabine; Carboplatin; Paclitaxel; Irinotecan; Doxorubicin; Liposomal doxorubicin; Topotecan; Iniparib
• Other Study ID Numbers: LTS12674; 2011-006246-33 (EudraCT Number); U1111-1127-0888 (Other Identifier: UTN)