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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
Open (Enrolling)
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

- 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:


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:


Principal Investigator

Clinical Sciences & Operations

Investigator Role:

Study Director

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

March 2014

Related Keywords:

  • Solid Tumors



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