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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

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 fo the regimen at the dose/schedule that isto 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.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 96
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 204

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) specificied 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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;Secondary Objective: not applicabile;Primary end point(s): Number of participants with incidence of adverse events by NCI-CTCAE version 4.03;Timepoint(s) of evaluation of this end point: During treatment and up to 30 days after last treatment dose

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable

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