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

NCT01593228 | Completed Phase 3

• 3 other identifiers: LTS126742011-006246-33U1111-1127-0888
• Study Type: interventional
• Target: 37
• Locations: 4 countries
• Sites: 32

Brief Summary

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

• Number of participants with incidence of adverse events by NCI-CTCAE version 4.03

  Up to 30 days after last treatment dose

Study Arms (1)

1

EXPERIMENTAL

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); Drug: Carboplatin; Drug: Doxorubicin HCL liposome injection; Drug: Gemcitabine; Drug: Irinotecan; Drug: Paclitaxel; Drug: Topotecan

Interventions

Iniparib (SAR240550/BSI-201) DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

1

Carboplatin DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

1

Doxorubicin HCL liposome injection DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

1

Gemcitabine DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

1

Irinotecan DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

1

Paclitaxel DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

1

Topotecan DRUG

Pharmaceutical form:Solution Route of administration: Intravenous

1

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (32)

Investigational Site Number 840013

Birmingham, Alabama, 35205, United States

Location

Investigational Site Number 840033

Santa Maria, California, 93454-8903, United States

Location

Investigational Site Number 840046

Vallejo, California, 94589, United States

Location

Investigational Site Number 840008

Denver, Colorado, 80218, United States

Location

Investigational Site Number 840027

Jacksonville, Florida, 32256, United States

Location

Investigational Site Number 840063

Augusta, Georgia, 30912, United States

Location

Investigational Site Number 840055

Tucker, Georgia, 30084, United States

Location

Investigational Site Number 840039

Maywood, Illinois, 60153, United States

Location

Investigational Site Number 840012

Indianapolis, Indiana, 46227, United States

Location

Investigational Site Number 840025

Sioux City, Iowa, 51105, United States

Location

Investigational Site Number 840030

Boston, Massachusetts, 02115, United States

Location

Investigational Site Number 840001

Detroit, Michigan, 48201, United States

Location

Investigational Site Number 840006

Minneapolis, Minnesota, 55407-3799, United States

Location

Investigational Site Number 840002

Jackson, Mississippi, 39202, United States

Location

Investigational Site Number 840059

St Louis, Missouri, 63110, United States

Location

Investigational Site Number 840004

St Louis, Missouri, 63141, United States

Location

Investigational Site Number 840022

Las Vegas, Nevada, 89169, United States

Location

Investigational Site Number 840017

Voorhees Township, New Jersey, 08043, United States

Location

Investigational Site Number 840010

Albany, New York, 12206, United States

Location

Investigational Site Number 840015

Charlotte, North Carolina, United States

Location

Investigational Site Number 840060

Cincinnati, Ohio, United States

Location

Investigational Site Number 840043

Cleveland, Ohio, 44106, United States

Location

Investigational Site Number 840021

Pittsburgh, Pennsylvania, 15213, United States

Location

Investigational Site Number 840028

Memphis, Tennessee, 38120-2146, United States

Location

Investigational Site Number 840007

Austin, Texas, 78731, United States

Location

Investigational Site Number 840003

El Paso, Texas, 79915, United States

Location

Investigational Site Number 840019

Plano, Texas, 75075, United States

Location

Investigational Site Number 840005

Norfolk, Virginia, 23502, United States

Location

Investigational Site Number 840009

Vancouver, Washington, 98684, United States

Location

Investigational Site Number 056002

Leuven, 3000, Belgium

Location

Investigational Site Number 380002

Genova, 16132, Italy

Location

Investigational Site Number 724001

Valencia, 46010, Spain

Location

MeSH Terms

Interventions

iniparib; Carboplatin; Gemcitabine; Irinotecan; Paclitaxel; Topotecan

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Camptothecin; Alkaloids; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes

Study Officials

• Clinical Sciences & Operations

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 8, 2012
• Study Start: May 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 19, 2017

Record last verified: 2017-09

Locations

ES (1); US (29); BE (1); IT (1)