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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


Phase 3
18 Years
N/A
Open (Enrolling)
Both
Solid Tumors

Thank you

Trial Information

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 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.

Inclusion 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.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Up to 30 days after last treatment dose

Safety Issue:

Yes

Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

LTS12674

NCT ID:

NCT01593228

Start Date:

May 2012

Completion Date:

March 2014

Related Keywords:

  • Solid Tumors

Name

Location

Investigational Site Number 840046La Jolla, California  92037
Investigational Site Number 840027Jacksonville, Florida  32256
Investigational Site Number 840017East Orange, New Jersey  07018
Investigational Site Number 840028Chattanooga, Tennessee  37404
Investigational Site Number 840006Rochester, Minnesota  55905
Investigational Site Number 840001Detroit, Michigan  48201
Investigational Site Number 840003Dallas, Texas  75230
Investigational Site Number 840013Birmingham, Alabama  35205
Investigational Site Number 840025Sioux City, Iowa  51105
Investigational Site Number 840002Jackson, Mississippi  39202
Investigational Site Number 840010Albany, New York  12206
Investigational Site Number 840007Austin, Texas  78731
Investigational Site Number 840019Plano, Texas  75075
Investigational Site Number 840033Santa Maria, California  93454-8903
Investigational Site Number 840008Denver, Colorado  80218
Investigational Site Number 840055Tucker, Georgia  30084
Investigational Site Number 840039Maywood, Illinois  60153
Investigational Site Number 840012Indianapolis, Indiana  46227
Investigational Site Number 840030Boston, Massachusetts  02115
Investigational Site Number 840004St. Louis, Missouri  63141
Investigational Site Number 840022Las Vegas, Nevada  89169
Investigational Site Number 840015Charlotte, North Carolina  28204
Investigational Site Number 840043Cleveland, Ohio  44106
Investigational Site Number 840021Pittsburgh, Pennsylvania  15213
Investigational Site Number 840005Norfolk, Virginia  23502
Investigational Site Number 840009Vancouver, Washington  98684