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Sponsors and Collaborators: |
Abbott Genentech |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00445198 |
The Phase 1 portion of the study will evaluate the pharmacokinetic profile and safety of ABT-263 with the objective of defining the dose limiting toxicity and maximum tolerated dose.
The Phase 2a portion of the study will evaluate ABT-263 at the defined recommended Phase 2 dose to obtain additional safety information and a preliminary assessment of efficacy.
Condition | Intervention | Phase |
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Small Cell Lung Cancer Non-Hematological Malignancies |
Drug: ABT-263 |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase 1/2a Study Evaluating the Safety, Pharmacokinetics, and Efficacy of ABT-263 in Subjects With Small Cell Lung Cancer (SCLC) or Other Non-Hematological Malignancies |
Estimated Enrollment: | 76 |
Study Start Date: | April 2007 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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40 SCLC patients: Experimental |
Drug: ABT-263
Dose escalation (CRM-design) starting at 10mg.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate bone marrow, renal & hepatic function per local lab reference range at Screening as follows:
Surgically sterile postmenopausal(for at least one year) or a negative pregnancy test performed as follows:
All female subjects not surgically sterile or postmenopausal(for at least 1 year)and non-vasectomized male subject must practice at least one of the following methods for birth control:
Exclusion Criteria:
Previous or current malignancies at other sites, with the exception of:
Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
Contact: Cathy Nolan | 847-937-2404 | cathy.nolan@abbott.com |
United States, Arizona | |
Dedicated Phase I | Completed |
Phoenix, Arizona, United States, 85013 | |
United States, California | |
UC Davis Cancer Center | Recruiting |
Sacramento, California, United States, 95817 | |
Contact: Grace Loredo 916-843-7133 grace.loredo@ucdmc.ucdavis.edu | |
Principal Investigator: David R Gandara, MD | |
United States, Colorado | |
University of Colorado Cancer Centre | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: DeLee Peake 303-724-1659 delee.peake@uchsc.edu | |
Principal Investigator: Ross Camidge, MD | |
United States, Illinois | |
Rush University Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Deborah Pach 312-563-3347 deborah_b_pach@rush.edu | |
Principal Investigator: Philip D. Bonomi,, MD, MS | |
United States, Maryland | |
Johns Hopkins University | Recruiting |
Baltimore, Maryland, United States, 21231 | |
Contact: Susan Markus 443-287-2911 smarkus@jhmi.edu | |
Principal Investigator: Charles M Rudin, MD, PhD | |
United States, Massachusetts | |
Dana Farber Cancer Institute | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Sara Thiede 617-632-5955 sthiede@dfci.harvard.edu | |
Principal Investigator: Geoffry Shapiro, MD | |
United States, Washington | |
Northwest Medical Specialties, PLLC | Recruiting |
Tacoma, Washington, United States, 98407 | |
Contact: Julie Skarsvog 253-396-5329 jskarsvog@nwmsonline.com | |
Principal Investigator: Moacyr Ribeiro de Oliveira, MD | |
United Kingdom | |
Christie Hospital | Recruiting |
Manchester, United Kingdom, M20 4BX |
Study Director: | Global Medical Information (1-800-633-9110) | Abbott |
Responsible Party: | Abbott ( Diane Medina ) |
Study ID Numbers: | M06-822 |
Study First Received: | March 6, 2007 |
Last Updated: | November 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00445198 |
Health Authority: | United States: Food and Drug Administration |
SCLC |
Thoracic Neoplasms Carcinoma, Neuroendocrine Carcinoma Neuroendocrine Tumors Carcinoma, Small Cell Neuroectodermal Tumors Respiratory Tract Diseases |
Lung Neoplasms Lung Diseases Neoplasms, Germ Cell and Embryonal Neuroepithelioma Adenocarcinoma Neoplasms, Glandular and Epithelial |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Nerve Tissue |