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

Solid Tumors 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593228
• Other study ID #: LTS12674
• Secondary ID: 2011-006246-33U1
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2012
• Last updated: September 12, 2017
• Start date: May 2012
• Est. completion date: September 2016

Study information

• Verified date: September 2017
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumors

Intervention

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

Locations

Country	Name	City	State
Belgium	Investigational Site Number 056002	Leuven
Italy	Investigational Site Number 380002	Genova
Spain	Investigational Site Number 724001	Valencia
United States	Investigational Site Number 840010	Albany	New York
United States	Investigational Site Number 840063	Augusta	Georgia
United States	Investigational Site Number 840007	Austin	Texas
United States	Investigational Site Number 840013	Birmingham	Alabama
United States	Investigational Site Number 840030	Boston	Massachusetts
United States	Investigational Site Number 840015	Charlotte	North Carolina
United States	Investigational Site Number 840060	Cincinnati	Ohio
United States	Investigational Site Number 840043	Cleveland	Ohio
United States	Investigational Site Number 840008	Denver	Colorado
United States	Investigational Site Number 840001	Detroit	Michigan
United States	Investigational Site Number 840003	El Paso	Texas
United States	Investigational Site Number 840012	Indianapolis	Indiana
United States	Investigational Site Number 840002	Jackson	Mississippi
United States	Investigational Site Number 840027	Jacksonville	Florida
United States	Investigational Site Number 840022	Las Vegas	Nevada
United States	Investigational Site Number 840039	Maywood	Illinois
United States	Investigational Site Number 840028	Memphis	Tennessee
United States	Investigational Site Number 840006	Minneapolis	Minnesota
United States	Investigational Site Number 840005	Norfolk	Virginia
United States	Investigational Site Number 840021	Pittsburgh	Pennsylvania
United States	Investigational Site Number 840019	Plano	Texas
United States	Investigational Site Number 840004	Saint Louis	Missouri
United States	Investigational Site Number 840059	Saint Louis	Missouri
United States	Investigational Site Number 840033	Santa Maria	California
United States	Investigational Site Number 840025	Sioux City	Iowa
United States	Investigational Site Number 840055	Tucker	Georgia
United States	Investigational Site Number 840046	Vallejo	California
United States	Investigational Site Number 840009	Vancouver	Washington
United States	Investigational Site Number 840017	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Belgium,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with incidence of adverse events by NCI-CTCAE version 4.03		Up to 30 days after last treatment dose