## Protocol Section
### Identification Module
**NCT ID:** NCT00677079

**Brief Title:** Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

**Official Title:** A Phase 2, Single Arm Study of BSI-201 in Patients With BRCA-1 or BRCA-2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

#### Organization Study ID Info
**ID:** ARD11489
#### Organization
**Class:** INDUSTRY
**Full Name:** Sanofi
#### Secondary ID Infos
**Domain:** BiPar
**ID:** 20080105
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Disp First Post Date
**Date:** 2012-12-28

**Type:** ESTIMATED

**Disp First Submit Date:** 2012-12-21
**Disp First Submit QC Date:** 2012-12-21

#### Expanded Access Info
**Has Expanded Access:** True
**Status For NCT ID:** NO_LONGER_AVAILABLE
#### Last Update Post Date
**Date:** 2013-10-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-09-23

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2008-12

**Type:** ACTUAL

#### Start Date
**Date:** 2008-06

**Status Verified Date:** 2013-09

#### Study First Post Date
**Date:** 2008-05-13
**Type:** ESTIMATED
**Study First Submit Date:** 2008-05-09
**Study First Submit QC Date:** 2008-05-12
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Sanofi

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The goal of this study was to determine the efficacy of iniparib (BSI-201/SAR240550) in patients with breast cancer gene-associated (BRCA) ovarian cancer.

Up to 35 patients were to be treated using a Simon 2-stage optimal design, i.e. twelve were to be treated in a first stage, then if 2/12 patients responded to treatment as defined by Response Evaluation Criteria in Solid Tumor (RECIST), 23 additional patients were be treated in the second stage.

**Detailed Description:** Participants were treated for at least one 8-week cycle, with additional cycles as long as they had stable or responding disease (per RECIST criteria) and wished to remain on study.

Participants had a final follow-up visit within 4 weeks following the last dose of iniparib, after which time they were contacted by study staff every 3 months for the first year and every 6 months thereafter to assess disease status and survival.

### Conditions Module

**Conditions:**

- Primary Peritoneal Cancer

- Advanced Epithelial Ovarian Cancer

**Keywords:**

- BRCA-1 or BRCA-2 associated advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer

- BRCA-1

- BRCA-2

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 12

**Type:** ACTUAL

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Iniparib, twice weekly on Days 1 and 4 of each week during 8-week cycles

**Intervention Names:**

- Drug: Iniparib

**Label:** Iniparib

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Iniparib

**Description:** Body weight adjusted dose

1 hour intravenous infusion

**Name:** Iniparib

**Other Names:**

- BSI-201

- SAR240550

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** Best overall response was defined as the best evaluation observed through the entire treatment period based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria.

**Measure:** Best overall response

**Time Frame:** until treatment discontinuation (assessment at the at the end of each 8-week cycle)

**Description:** Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to RECIST criteria.

**Measure:** Objective response rate

**Time Frame:** until treatment discontinuation (assessment at the at the end of each 8-week cycle)

#### Secondary Outcomes

**Description:** Clinical benefit rate was defined as the percentage of participants with complete response, partial response or stable disease according to RECIST criteria.

**Measure:** Clinical benefit rate

**Time Frame:** until treatment discontinuation (assessment at the at the end of each 8-week cycle)

**Description:** Progression-free survival was defined as the time interval from study entry until disease progression or death due to any cause, whichever came first.

In the absence disease progression or death, progression-free survival was censored at the last date the participant was known to be alive.

**Measure:** Progression-Free Survival

**Time Frame:** until death or study end

**Description:** Overall Survival was defined as the time interval from study entry until death due to any cause.

In the absence of confirmation of death, progression-free survival was censored at the last date the participant was known to be alive.

**Measure:** Overall Survival

**Time Frame:** until death or study end

**Description:** Objective response rate was defined as the percentage of participants with confirmed partial response or complete response according to CA125 levels.

**Measure:** Cancer antigen 125 response (participants with elevated CA125)

**Time Frame:** until treatment discontinuation (assessment at the at the end of each 8-week cycle)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Female, age 18 or older;
* Histologically or cytologically confirmed advanced epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer (stage III or IV);
* At least one previous regimen with platinum/taxane combination therapy and no curative options as determined by their physician (no limit on the number of prior therapies);
* Confirmed BRCA1 or BRCA2 status;
* One or more measurable lesions, at least 10mm in longest diameter by spiral computed tomography (CT) scan or 20mm in longest diameter when measured with conventional techniques (palpation, plain x-ray, CT or magnetic resonance imaging (MRI));
* Karnofsky performance status ≥70%;
* Estimated life expectancy of at least 16 weeks.

Exclusion Criteria:

* Normal clinical laboratory values;
* Any anti-cancer therapy within 21 days prior to study start;
* Any other malignancy within 3 years of study start, except adequately treated carcinoma in situ of the cervix, ductal carcinoma in situ (DCIS) of the breast, or basal or squamous cell skin cancer;
* Active viral infection including HIV/AIDS, Hepatitis B or Hepatitis C infection;
* Active central nervous system or brain metastases;
* History of seizures or current treatment with anti-epileptic medication;
* Persistent grade 2 or greater toxicities from prior therapy, excluding alopecia.

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**State:** New York

**Zip:** 10021

#### Overall Officials

**Official 1:**

**Affiliation:** Sanofi

**Name:** Clinical Sciences & Operations

**Role:** STUDY_DIRECTOR

### References Module

#### References

**Citation:** Bell-McGuinn KM, Konner JA, Tew WP, Hensley ML, Iasonos A, Charpentier E, Mironov S, Sabbatini P, Aghajanian C. A Phase 2, Single Arm Study of Iniparib in Patients With BRCA1 or BRCA2 Associated Advanced Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Int J Gynecol Cancer. 2016 Feb;26(2):255-60. doi: 10.1097/IGC.0000000000000591.

**PMID:** 26745694

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010051

- Term: Ovarian Neoplasms

- ID: D000004701

- Term: Endocrine Gland Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000010049

- Term: Ovarian Diseases

- ID: D000000291

- Term: Adnexal Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000005833

- Term: Genital Neoplasms, Female

- ID: D000014565

- Term: Urogenital Neoplasms

- ID: D000091662

- Term: Genital Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000006058

- Term: Gonadal Disorders

- ID: D000000008

- Term: Abdominal Neoplasms

- ID: D000004067

- Term: Digestive System Neoplasms

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000010532

- Term: Peritoneal Diseases

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M12974

- Name: Ovarian Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M1704

- Name: Carcinoma, Ovarian Epithelial

- Relevance: HIGH

- As Found: Epithelial Ovarian Cancer

- ID: M13443

- Name: Peritoneal Neoplasms

- Relevance: HIGH

- As Found: Peritoneal Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M7863

- Name: Endocrine Gland Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M12972

- Name: Ovarian Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M3643

- Name: Adnexal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8945

- Name: Genital Neoplasms, Female

- Relevance: LOW

- As Found: Unknown

- ID: M17315

- Name: Urogenital Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9163

- Name: Gonadal Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7

- Name: Abdominal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M8886

- Name: Gastrointestinal Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7256

- Name: Digestive System Neoplasms

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M13441

- Name: Peritoneal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: T4352

- Name: Ovarian Cancer

- Relevance: HIGH

- As Found: Epithelial Ovarian Cancer

- ID: T4354

- Name: Ovarian Epithelial Cancer

- Relevance: HIGH

- As Found: Epithelial Ovarian Cancer

### Condition Browse Module - Meshes

- ID: D000010534

- Term: Peritoneal Neoplasms

- ID: D000077216

- Term: Carcinoma, Ovarian Epithelial

### Intervention Browse Module - Ancestors

- ID: D000067856

- Term: Poly(ADP-ribose) Polymerase Inhibitors

- ID: D000004791

- Term: Enzyme Inhibitors

- ID: D000045504

- Term: Molecular Mechanisms of Pharmacological Action

- ID: D000000970

- Term: Antineoplastic Agents

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M233006

- Name: Iniparib

- Relevance: HIGH

- As Found: Vaccine administration

- ID: M205

- Name: Poly(ADP-ribose) Polymerase Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M7951

- Name: Enzyme Inhibitors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: C000090712

- Term: Iniparib

### Misc Info Module

- Version Holder: 2024-05-24
