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

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 :

- 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.