A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by AbbVie
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02009631
First received: December 9, 2013
Last updated: July 25, 2014
Last verified: July 2014
  Purpose

This is a randomized Phase 1 study to evaluate the effects of Veliparib on cardiac repolarization in patients with solid tumors who's cancer has recurred or is no longer responding to current treatment.


Condition Intervention Phase
Breast Cancer
Ovarian Cancer
Colon Cancer
Lung Cancer
Gastric Cancer
Solid Tumors
Drug: Veliparib (ABT-888)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Official Title: A Randomized, Placebo-Controlled Crossover Study to Evaluate the Effect of Veliparib (ABT-888) on Cardiac Repolarization in Subjects With Relapsed or Refractory Solid Tumors

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • To evaluate the effect of Veliparib on corrected QT interval calculated by Fridericia's formula (QTcF) [ Time Frame: Electrocardiograms (ECGs) will be done at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 in triplicate, 1 time point on Day 2 of Periods 1, 2, and 3 and 1 time point on Day 3 of Period 3. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetic sampling maximum observed plasma concentration (Cmax) [ Time Frame: Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3. ] [ Designated as safety issue: No ]
  • Pharmacokinetic sampling - time to maximum observed plasma concentration (Tmax) [ Time Frame: Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3. ] [ Designated as safety issue: No ]
  • Pharmacokinetic sampling - the area under the plasma concentration-time curve (AUC) from time 0-24 hours (AUC 0-24) [ Time Frame: Pharmacokinetic samples will be drawn at Screening, 6 time points on Day 1 of Periods 1, 2 and 3 and 1 time point on Day 2 of Periods 1, 2, and 3. ] [ Designated as safety issue: No ]
  • The number of subjects with adverse events [ Time Frame: Up to 30 days after last dose of study drug. ] [ Designated as safety issue: Yes ]
  • Vital Signs [ Time Frame: Up to 30 days after last dose of study drug. ] [ Designated as safety issue: Yes ]
    Blood pressure, heart rate and temperature.

  • Clinical Laboratory Tests [ Time Frame: Up to 30 days after last dose of study drug. ] [ Designated as safety issue: Yes ]
    Hematology, chemistry, urinalysis

  • Tumor Assessment [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
    A computerized tomography scan will be done at screening to document tumor size.


Estimated Enrollment: 48
Study Start Date: November 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sequence Group A
200 mg Veliparib
Drug: Veliparib (ABT-888)
Experimental: Sequence Group B
400 mg Veliparib
Drug: Veliparib (ABT-888)
Placebo Comparator: Sequence Group C
Placebo
Drug: Placebo

  Eligibility

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

Inclusion Criteria:

  • Confirmed solid malignancy that is metastatic or unresectable for which standard curative measures or other therapy that may provide clinical benefit do not exist or are no longer effective.
  • Subjects with brain metastases must have clinically controlled neurologic symptoms.
  • Subject is able to swallow and retain oral medications and does not have uncontrolled emesis.
  • Subject has adequate bone marrow, renal and hepatic function per local laboratory reference ranges.

Exclusion Criteria:

  • Uncorrected serum potassium, serum magnesium, serum calcium or free thyroxin (FT4) and thyroid stimulating hormone (TSH) outside of normal reference ranges, or grade 2 hyponatremia or hypernatremia.
  • Subject has severe ECG morphologic abnormalities that make QTc evaluation difficult.
  • Subject has a history of cardiac conduction abnormalities.
  • Subject has a significant history of cardiovascular disease.
  • Subject has received any anti-cancer therapies 21 days prior to the first dose of study drug, or has recovered to no better than a grade 2 or higher clinically significant adverse effect(s)/toxicity(s) of the previous therapy.
  • Use of drugs with a known risk for QT prolongation and Torsades de Pointes within 7 days prior to the first study dose.
  • Use of tobacco or nicotine-containing products within 12 hours prior to the first study dose.
  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: NCT02009631

Contacts
Contact: Diane M Medina, BA 847-935-3868 diane.medina@abbvie.com
Contact: Xenia Kovacs, BA 847-938-4057 xenia.kovacs@abbvie.com

Locations
United States, Arizona
Site Reference ID/Investigator# 116015 Recruiting
Scottsdale, Arizona, United States, 85258
Principal Investigator: Site Reference ID/Investigator# 116015         
United States, Texas
Site Reference ID/Investigator# 116016 Recruiting
San Antonio, Texas, United States, 78229
Principal Investigator: Site Reference ID/Investigator# 116016         
United States, Wisconsin
Site Reference ID/Investigator# 39966 Not yet recruiting
West Bend, Wisconsin, United States, 53095
Principal Investigator: Site Reference ID/Investigator# 39966         
Netherlands
Site Reference ID/Investigator# 117320 Recruiting
Groningn, Netherlands, 9713 GZ
Principal Investigator: Site Reference ID/Investigator# 117320         
Site Reference ID/Investigator# 117336 Recruiting
Maastricht, Netherlands, 6229 HX
Principal Investigator: Site Reference ID/Investigator# 117336         
Spain
Site Reference ID/Investigator# 117517 Recruiting
Madrid, Spain, 28050
Principal Investigator: Site Reference ID/Investigator# 117517         
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Stacie Shepherd, PhD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02009631     History of Changes
Other Study ID Numbers: M12-020, 2013-002028-18
Study First Received: December 9, 2013
Last Updated: July 25, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
United States: Food and Drug Administration

Keywords provided by AbbVie:
Solid Tumors
Ovarian Cancer
Colon Cancer
Lung Cancer
Breast Cancer
Gastric Cancer

Additional relevant MeSH terms:
Neoplasms
Lung Neoplasms
Ovarian Neoplasms
Stomach Neoplasms
Breast Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 16, 2014