A Study Evaluating INIPARIB in Combination With Chemother... | NCT01173497

Studies
A Study Evaluating INIPARIB in Combination With Chemotherapy to Treat Triple Negative Breast Cancer Brain Metastasis

NCT01173497

Sponsor

Sanofi

Status

Completed

Last Update Posted

Mar 17, 2016Estimated

Enrollment

44Actual

Phase

Phase 2

Conditions

Estrogen Receptor Negative (ER-Negative) Breast Cancer
Progesterone Receptor Negative (PR-Negative) Breast Cancer
Human Epidermal Growth Factor Receptor 2 Negative (HER2-Negative) Breast Cancer
Brain Metastases

Interventions

INIPARIB + irinotecan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
20100210	Other Identifier	BiPar

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

YesNCT01130259No longer available

Start Date

Jul 2010

Primary Completion Date

Oct 2012Actual

Completion Date

Jul 2013Actual

First Submitted Date

Jul 28, 2010

First Submission Date that Met QC Criteria

Jul 29, 2010

First Posted Date

Aug 2, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Feb 17, 2016

Certification/Extension First Submitted that Passed QC Review

Feb 17, 2016

Certification/Extension First Posted Date

Mar 17, 2016Estimated

Last Update Submitted Date

Feb 17, 2016

Last Update Posted Date

Mar 17, 2016Estimated

Name	Class
UNC Lineberger Comprehensive Cancer Center	OTHER

Description Module

Brief Summary

The purpose of the study is to investigate the response rate for triple negative breast cancer patients with brain metastasis when INIPARIB is used in combination with irinotecan.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Label	Type	Description	Intervention Names
INIPARIB, irinotecan	Experimental		Drug: INIPARIB + irinotecan

Name	Type	Description	Arm Group Labels	Other Names
INIPARIB + irinotecan	Drug	21 day cycle	INIPARIB, irinotecan

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy	AS measured by intra or extra cranial time to progression (TTP)	12 months

Secondary Outcomes

Measure	Description	Time Frame
Response Rate	as measured by RECIST	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria -

Histologically-confirmed, ER negative, PR negative and Her2 negative adenocarcinoma of the breast with brain lesion on radiographic imaging.
ECOG Performance Status of 0-2.
Life expectancy of >12 weeks.
No limit to prior therapies with last anti-cancer treatment ≥ 2 weeks from initiation of protocol-based therapy provided all toxicities (other than alopecia) have resolved to ≤Grade 1 or baseline.
No active serious infection or other comorbid illness which would impair ability to participate in the trial.
Stable or decreasing dose of steroids for ≥ 7 days.
Interval ≥ 4 weeks between open brain biopsy and initiation of protocol-based therapy.
Patients must have adequate organ function.

Exclusion Criteria -

Pregnant or breast-feeding
Prior allergic reaction to INIPARIB
Prior allergic reaction to irinotecan.
Evidence of hemorrhage or impending herniation on baseline brain imaging
Evidence of diffuse leptomeningeal disease on brain MRI or by previously documented CSF cytology-NOTE: discrete dural metastases are permitted.
Clinically significant cardiac, renal, hepatic, infectious or pulmonary disease which might affect trial participation.
Concurrent or planned radiation, hormonal, chemotherapeutic, experimental or targeted biologic therapy.
Contraindication to gadolinium-enhanced MRI imaging.
Inability to comply with study and/or follow-up procedures.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
University of Alabama At Birmingham		Birmingham	Alabama		United States
University of California At San Francisco

ID	Term
D001943	Breast Neoplasms
D001932	Brain Neoplasms
D064726	Triple Negative Breast Neoplasms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
C090712	iniparib
D000077146	Irinotecan

ID	Term
D002166	Camptothecin
D000470	Alkaloids
D006571	Heterocyclic Compounds