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

December 9, 2013
July 25, 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. ] [ Designated as safety issue: Yes ]
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. ] [ 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.
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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.
 
Recruiting
48
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.
Both
18 Years and older
No
Contact: Diane M Medina, BA 847-935-3868 diane.medina@abbvie.com
Contact: Xenia Kovacs, BA 847-938-4057 xenia.kovacs@abbvie.com
United States,   Netherlands,   Spain
 
NCT02009631
M12-020, 2013-002028-18
No
AbbVie
AbbVie
Not Provided
Study Director: Stacie Shepherd, PhD AbbVie
AbbVie
July 2014

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