NCT00298675

Brief Summary

The purpose of this study is to assess the safety, establish the maximum tolerated dose (MTD) and generate pharmacokinetic profiles of BSI-201 after IV administration in adult subjects with histologically documented advanced solid tumors that are refractory to standard therapy or for which no standard therapy is available. Additionally, the safety and tolerability and clinical response of BSI-201 + irinotecan will be investigated in patients with metastatic breast cancer in the phase 1b portion of the study. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Mar 2006

Longer than P75 for phase_1

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 3, 2006

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

August 2, 2012

Status Verified

August 1, 2012

Enrollment Period

4.3 years

First QC Date

March 1, 2006

Last Update Submit

August 1, 2012

Conditions

Tumors

Outcome Measures

Primary Outcomes (1)

  • Maximum tolerated dose

    After one cycle

Secondary Outcomes (1)

  • Clinical Response

    8 months

Study Arms (2)

Iniparib

EXPERIMENTAL
Drug: BSI-201 (iniparib)

Iniparib/irinotecan

EXPERIMENTAL
Drug: BSI-201 (iniparib)Drug: irinotecan

Interventions

BSI-201 (iniparib)DRUG

BSI-201 administered intravenously (IV), 2x weekly

Also known as: SAR240550
IniparibIniparib/irinotecan
irinotecanDRUG

Irinotecan administered weekly, IV.

Iniparib/irinotecan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically documented, advanced solid tumor that is refractory to standard therapy or for which no standard therapy is available.
  • ECOG performance status of 0, 1, or 2
  • Adequate hematological status
  • Any prior toxicity from prior chemotherapeutic treatment recovered to grade 1 or grade 0
  • years of age or older
  • Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
  • For phase 1b portion only: metastatic breast cancer

You may not qualify if:

  • Hematologic malignancies
  • Symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids
  • Myocardial infarction within 6 months of study day 1, unstable angina, congestive heart failure with NYHA \> class II, uncontrolled hypertension
  • Known positive test for HIV or hepatitis C virus, or chronic active hepatitis
  • Major surgery within 1 month of study day 1
  • History of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary cancer with no known active disease present and no curative treatment administered for the last 3 years
  • History of seizure disorder or currently on anti-seizure medication
  • Systemic chemotherapy or radiation therapy within 28 days of study day 1
  • Antibody therapy for treatment of underlying malignancy within 1 month of study day 1
  • Evidence of liver disease shown by elevated enzymes
  • Evidence of renal disease shown by serum creatinine \> 1.5 x upper limit of normal
  • Currently receiving platelet of GCF support for any medical condition
  • Concurrent use of herbal medications taken with the intent to treat cancer
  • Enrolled in or not yet completed at least 30 days since ending other investigational device or drug study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Research Site

New Haven, Connecticut, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

San Antonio, Texas, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

iniparibIrinotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

March 1, 2006

First Posted

March 3, 2006

Study Start

March 1, 2006

Primary Completion

July 1, 2010

Study Completion

May 1, 2011

Last Updated

August 2, 2012

Record last verified: 2012-08

Locations

US(3)