A Study Evaluating Veliparib as a Single Agent or in Combination With Chemotherapy in Subjects With Solid Tumors

Breast Cancer Clinical Trial

Official title:

An Extension Study to Evaluate the Safety of Veliparib as Single Agent Therapy or in Combination With Chemotherapy in Subjects With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02033551
• Other study ID #: M14-144
• Secondary ID: 2013-003137-16
• Status: Completed
• Phase: Phase 1
• First received: January 8, 2014
• Last updated: September 26, 2016
• Start date: December 2013
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationSpain: Comité Ético de Investigación ClínicaSpain: Agencia Española de Medicamentos y Productos SanitariosNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

This is an extension study to evaluate the safety of Veliparib monotherapy or in combination with Carboplatin plus Paclitaxel or modified Folinic Acid/Fluorouracil/Irinotecan (FOLFIRI) in subjects with solid tumors.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Must have confirmed solid malignancy that is metastatic, and standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.

• For Veliparib monotherapy (must have tumor with defects in DNA repair mechanisms (BRCA mutation or high grade ovarian cancer or solid tumors for combination therapy.

• If the subject has known brain metastases must have clinically controlled neurologic symptoms, defined as surgical excision and/or radiation therapy followed by 21 days of stable neurologic function and no evidence of Central Nervous System (CNS) disease progression as determined by comparing a computed tomography (CT) scan or magnetic resonance imaging (MRI) scan performed during screening to a prior scan performed at least 4 weeks earlier and provided that the subject is asymptomatic, has no evidence of cavitation or hemorrhage, and does not require corticosteroids (must have discontinued steroids at least 3 months prior to study drug administration).

• Subject must have adequate bone marrow, renal and hepatic function per local laboratory reference range.

Exclusion Criteria:

• Subject has a clinically significant and uncontrolled major medical condition(s) including but not limited to:

• Uncontrolled seizure disorder, including focal or generalized seizure within the last 12 months;

• Uncontrolled nausea/vomiting/diarrhea;

• Active uncontrolled infection;

• Symptomatic congestive heart failure;

• Unstable angina pectoris or cardiac arrhythmia;

• Psychiatric illness/social situation that would limit compliance with study requirements;

• Any medical condition, which in the opinion of the study investigator, places the subject at an unacceptably high risk for toxicities.

• Subjects who have hypersensitivity to Carboplatin, Paclitaxel or Cremophor should be excluded from arm B.

• Subject has received any of the following anti-cancer therapies 21 days prior to the first dose of study drug or a biologic agent for anti-neoplastic intent within 30 days prior to the first dose of study drug.

• Subject who requires parenteral nutrition, tube feeding or has evidence of a partial bowel obstruction or perforation within 28 days prior to study drug.

• The subject has had another active malignancy within the past 3 years except for any cancer in situ that the Principal Investigator considers to be cured.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Colon Cancer
• Colonic Neoplasms
• Gastric Cancer
• Lung Cancer
• Lung Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Solid Tumors
• Stomach Neoplasms

Intervention

Drug:
• Veliparib

• Carboplatin

• Paclitaxel

• FOLFIRI
combination of Fluorouracil, leucovorin and irinotecan

Locations

Country	Name	City	State
Netherlands	Site Reference ID/Investigator# 117337	Groningen
Netherlands	Site Reference ID/Investigator# 117338	Maastricht
Spain	Site Reference ID/Investigator# 117451	Madrid
United States	Site Reference ID/Investigator# 117415	San Antonio	Texas
United States	Site Reference ID/Investigator# 117416	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		Measured up to 30 days after the last dose of study drug.	Yes
Secondary	Objective Response Rate (ORR)		Radiographic evaluation at Screening and every 6-9 weeks until the final visit, up to 18 months.	No
Secondary	Overall Survival (OS)		Every 3 months after the subject is registered off study up to 2 years post discontinuation or until date of death from any cause, whichever comes first.	No
Secondary	Time to Disease Progression (TTP)		Assessed at each visit up to 18 months after the last subject has enrolled in the study.	No
Secondary	Progression Free Survival (PFS)		Radiographic evaluation starting from the first day of study drug until documented progression or date of death, whichever comes first, until the subject is registered off study.	No
Secondary	Clinical Laboratory Tests	Hematology, Chemistry, Urinalysis	Up to 18 months.	Yes
Secondary	Electrocardiogram		Up to 18 months.	Yes
Secondary	Tumor Assessment	A computerized tomography scan to document the size of the tumor.	Up to 18 months.	Yes