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Sponsored by: |
Poniard Pharmaceuticals |
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Information provided by: | Poniard Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00116610 |
This is a Phase II research study that is designed for patients who have small cell lung cancer (SCLC) that is no longer responding to treatment. Patients will receive picoplatin, a new platinum-based agent that is currently under investigation, in 21-day cycles.
Condition | Intervention | Phase |
---|---|---|
Small Cell Lung Cancer |
Drug: picoplatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Picoplatin as Second-Line Therapy for Subjects With Resistant or Refractory Small Cell Lung Cancer |
Estimated Enrollment: | 75 |
Study Start Date: | June 2005 |
Estimated Study Completion Date: | August 2006 |
Platinum drugs work by binding to DNA and preventing the rapid cell division of tumors. However, many tumors demonstrate a resistance to platinum drugs. Results from preclinical studies indicate that picoplatin (previously called AMD473 or ZD0473) may be able to overcome or partially overcome platinum resistance. More than 500 patients have received picoplatin in previous Phase I or Phase II clinical trials.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Main inclusion criteria:
[Additional eligibility criteria apply.]
Exclusion Criteria:
[Additional exclusion criteria apply.]
Study Director: | Hazel Breitz, MD | Poniard Pharmaceuticals |
Study Director: | Paul Weiden, MD | Poniard Pharmaceuticals |
Study Director: | David Karlin, MD | Poniard Pharmaceuticals |
Study ID Numbers: | 0402, IND No. 69,507 |
Study First Received: | June 29, 2005 |
Last Updated: | February 14, 2007 |
ClinicalTrials.gov Identifier: | NCT00116610 |
Health Authority: | United States: Food and Drug Administration |
small cell lung cancer resistant refractory platinum |
chemotherapy second-line relapse sensitive |
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 |