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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
December 9, 2013
December 12, 2013
December 12, 2014
November 2013
December 2014   (Final data collection date for primary outcome measure)
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. ]
Same as current
Complete list of historical versions of study NCT02009631 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
A Study to Evaluate the Effects of Veliparib on Heart Rhythms in Patients With Solid Tumors
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
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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Breast Cancer
  • Ovarian Cancer
  • Colon Cancer
  • Lung Cancer
  • Gastric Cancer
  • Solid Tumors
  • Drug: Veliparib (ABT-888)
  • Drug: Placebo
  • Experimental: Sequence Group A
    200 mg Veliparib
    Intervention: Drug: Veliparib (ABT-888)
  • Experimental: Sequence Group B
    400 mg Veliparib
    Intervention: Drug: Veliparib (ABT-888)
  • Placebo Comparator: Sequence Group C
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2014
December 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands,   Spain,   United States
 
 
NCT02009631
M12-020
2013-002028-18 ( EudraCT Number )
No
Not Provided
Not Provided
AbbVie
AbbVie
Not Provided
Study Director: Stacie Shepherd, PhD AbbVie
AbbVie
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP