Spots Global Cancer Trial Database for A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
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Trial Identification
Brief Title: A Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Official Title: A Phase 1 Study of the Safety and Pharmacokinetics of Venetoclax in Pediatric and Young Adult Patients With Relapsed or Refractory Malignancies
Study ID: NCT03236857
Study Description
Brief Summary: An open-label, global, multi-center study to evaluate the safety and pharmacokinetics of venetoclax monotherapy, to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of venetoclax in pediatric and young adult participants with relapsed or refractory malignancies.
Detailed Description:
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Univ California, San Francisco /ID# 163460, San Francisco, California, United States
Children's Hospital Colorado /ID# 161551, Aurora, Colorado, United States
Children's Healthcare of Atlan /ID# 161552, Atlanta, Georgia, United States
Dana-Farber Cancer Institute /ID# 163440, Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 163444, New York, New York, United States
Cincinnati Children's Hospital /ID# 161550, Cincinnati, Ohio, United States
Children's Hospital of Philadelphia /ID# 163445, Philadelphia, Pennsylvania, United States
St Jude Children's Research Hospital /ID# 163447, Memphis, Tennessee, United States
Primary Children's /ID# 164399, Salt Lake City, Utah, United States
Seattle Children's Hospital /ID# 163459, Seattle, Washington, United States
Medical College of Wisconsin /ID# 163461, Milwaukee, Wisconsin, United States
Sydney Children's Hospital /ID# 163148, Randwick, New South Wales, Australia
Queensland Children's Hospital /ID# 163146, South Brisbane, Queensland, Australia
Women and Childrens Hospital /ID# 163147, North Adelaide, South Australia, Australia
Royal Children's Hospital /ID# 163104, Parkville, Victoria, Australia
Hospital for Sick Children /ID# 163726, Toronto, Ontario, Canada
CHU Sainte-Justine /ID# 163725, Montreal, Quebec, Canada
AP-HM - Hopital de la Timone /ID# 161465, Marseille CEDEX 05, Bouches-du-Rhone, France
Centre Leon Berard /ID# 163707, Lyon CEDEX 08, Rhone, France
AP-HP - Hopital Armand-Trousseau /ID# 163728, Paris, , France
Robert Debre Hopital, FR /ID# 161464, Paris, , France
CHU Toulouse - Hôpital des enfants /ID# 163727, Toulouse CEDEX 9, , France
Universitaetsklinikum Freiburg /ID# 164206, Freiburg, Baden-Wuerttemberg, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 161729, Kiel, Schleswig-Holstein, Germany
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 161730, Berlin, , Germany
Universitaetsklinikum Essen /ID# 164207, Essen, , Germany
Erasmus MC - Sophia /ID# 161579, Rotterdam, , Netherlands
Prinses Maxima Centrum /ID# 162670, Utrecht, , Netherlands
Kinderspital Zurich - Eleonorenstiftung /ID# 163037, Zurich, Zuerich, Switzerland
Great Ormond Street Hospital for Children /ID# 169238, London, London, City Of, United Kingdom
The Newcastle Upon Tyne Hospitals NHS Foundation Trust /ID# 162938, Newcastle Upon Tyne, , United Kingdom
Contact Details
Name: ABBVIE INC.
Affiliation: AbbVie
Role: STUDY_DIRECTOR
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