Clinical trial NCT01593228: Treatment Extension Study for Patients Who Have Previously Participated and Have Benefited From Iniparib in a Clinical Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Solid Tumors
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2012-05-08
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with incidence of adverse events by NCI-CTCAE version 4.03
timeFrame: Up to 30 days after last treatment dose
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Investigational Site Number 840013
state: Alabama
city: Santa Maria
country: United States
facility: Investigational Site Number 840033
state: California
city: Vallejo
country: United States
facility: Investigational Site Number 840046
state: California
city: Denver
country: United States
facility: Investigational Site Number 840008
state: Colorado
city: Jacksonville
country: United States
facility: Investigational Site Number 840027
state: Florida
city: Augusta
country: United States
facility: Investigational Site Number 840063
state: Georgia
city: Tucker
country: United States
facility: Investigational Site Number 840055
state: Georgia
city: Maywood
country: United States
facility: Investigational Site Number 840039
state: Illinois
city: Indianapolis
country: United States
facility: Investigational Site Number 840012
state: Indiana
city: Sioux City
country: United States
facility: Investigational Site Number 840025
state: Iowa
city: Boston
country: United States
facility: Investigational Site Number 840030
state: Massachusetts
city: Detroit
country: United States
facility: Investigational Site Number 840001
state: Michigan
city: Minneapolis
country: United States
facility: Investigational Site Number 840006
state: Minnesota
city: Jackson
country: United States
facility: Investigational Site Number 840002
state: Mississippi
city: Saint Louis
country: United States
facility: Investigational Site Number 840059
state: Missouri
city: Saint Louis
country: United States
facility: Investigational Site Number 840004
state: Missouri
city: Las Vegas
country: United States
facility: Investigational Site Number 840022
state: Nevada
city: Voorhees
country: United States
facility: Investigational Site Number 840017
state: New Jersey
city: Albany
country: United States
facility: Investigational Site Number 840010
state: New York
city: Charlotte
country: United States
facility: Investigational Site Number 840015
state: North Carolina
city: Cincinnati
country: United States
facility: Investigational Site Number 840060
state: Ohio
city: Cleveland
country: United States
facility: Investigational Site Number 840043
state: Ohio
city: Pittsburgh
country: United States
facility: Investigational Site Number 840021
state: Pennsylvania
city: Memphis
country: United States
facility: Investigational Site Number 840028
state: Tennessee
city: Austin
country: United States
facility: Investigational Site Number 840007
state: Texas
city: El Paso
country: United States
facility: Investigational Site Number 840003
state: Texas
city: Plano
country: United States
facility: Investigational Site Number 840019
state: Texas
city: Norfolk
country: United States
facility: Investigational Site Number 840005
state: Virginia
city: Vancouver
country: United States
facility: Investigational Site Number 840009
state: Washington
city: Leuven
country: Belgium
facility: Investigational Site Number 056002
city: Genova
country: Italy
facility: Investigational Site Number 380002
city: Valencia
country: Spain
facility: Investigational Site Number 724001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: