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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Sanofi
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01593228
First received: April 30, 2012
Last updated: September 14, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Solid Tumors
Drug: Iniparib (SAR240550/BSI-201)
Drug: Carboplatin
Drug: Doxorubicin HCL liposome injection
Drug: Gemcitabine
Drug: Irinotecan
Drug: Paclitaxel
Drug: Topotecan
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Number of participants with incidence of adverse events by NCI-CTCAE version 4.03 [ Time Frame: Up to 30 days after last treatment dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 41
Study Start Date: May 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1

Patients receiving iniparib alone or in combination with other anti-cancer agents as defined by the parental study. Interventions:

  • Drug: Iniparib monotherapy
  • Drug: Iniparib + gemcitabine + carboplatin
  • Drug: Iniparib + topotecan
  • Drug: Iniparib + irinotecan
  • Drug: Iniparib + paclitaxel
  • Drug: Iniparib + liposomal doxorubicin + carboplatin
Drug: Iniparib (SAR240550/BSI-201)

Pharmaceutical form:Solution

Route of administration: Intravenous

Drug: Carboplatin

Pharmaceutical form:Solution

Route of administration: Intravenous

Drug: Doxorubicin HCL liposome injection

Pharmaceutical form:Solution

Route of administration: Intravenous

Drug: Gemcitabine

Pharmaceutical form:Solution

Route of administration: Intravenous

Drug: Irinotecan

Pharmaceutical form:Solution

Route of administration: Intravenous

Drug: Paclitaxel

Pharmaceutical form:Solution

Route of administration: Intravenous

Drug: Topotecan

Pharmaceutical form:Solution

Route of administration: Intravenous


Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593228

Contacts
Contact: For site information, send an email with site number to Contact-Us@sanofi.com

  Show 29 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01593228     History of Changes
Other Study ID Numbers: LTS12674, 2011-006246-33, U1111-1127-0888
Study First Received: April 30, 2012
Last Updated: September 14, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Carboplatin
Doxorubicin
Gemcitabine
Irinotecan
Liposomal doxorubicin
Paclitaxel
Topotecan
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase I Inhibitors
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on October 21, 2014