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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02009631
First Posted: December 12, 2013
Last Update Posted: December 12, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AbbVie
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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. ]

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. ]
  • 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. ]
  • 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. ]
  • The number of subjects with adverse events [ Time Frame: Up to 30 days after last dose of study drug. ]
  • Vital Signs [ Time Frame: Up to 30 days after last dose of study drug. ]
    Blood pressure, heart rate and temperature.

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

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


Enrollment: 45
Study Start Date: November 2013
Study Completion Date: December 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02009631


Locations
United States, Arizona
Site Reference ID/Investigator# 116015
Scottsdale, Arizona, United States, 85258
United States, Texas
Site Reference ID/Investigator# 116016
San Antonio, Texas, United States, 78229
Netherlands
Site Reference ID/Investigator# 117320
Groningn, Netherlands, 9713 GZ
Site Reference ID/Investigator# 117336
Maastricht, Netherlands, 6229 HX
Spain
Site Reference ID/Investigator# 117517
Madrid, Spain, 28050
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Stacie Shepherd, PhD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02009631     History of Changes
Other Study ID Numbers: M12-020
2013-002028-18 ( EudraCT Number )
First Submitted: December 9, 2013
First Posted: December 12, 2013
Last Update Posted: December 12, 2014
Last Verified: December 2014

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

Additional relevant MeSH terms:
Ovarian Neoplasms
Stomach Neoplasms
Colonic Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
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
Colorectal Neoplasms
Intestinal Neoplasms
Colonic Diseases
Intestinal Diseases
Veliparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents