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Sponsored by: |
Hana Biosciences, Inc |
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Information provided by: | Hana Biosciences, Inc |
ClinicalTrials.gov Identifier: | NCT00765973 |
A multi-center, open-label, two-arm, dose-escalation study to establish the safety, tolerability, MTD, and schedule of TLI administered intravenously as a 30 minute infusion in adult subjects with advanced solid tumors that have relapsed, are refractory to standard therapy, or for whom there is no standard therapy available.
The two dosing regimens to be evaluated are:
When one of the two arms reaches MTD, all future subjects will then be enrolled in the remaining study arm until MTD of that arm is reached.
Condition | Intervention | Phase |
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Small Cell Lung Cancer Ovarian Cancer Solid Tumors |
Drug: Topotecan Liposomes Injection (TLI) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | A Phase 1 Study of Topotecan Liposomes Injection (TLI) in Subjects With Small Cell Lung Cancer (SCLC), Ovarian Cancer and Other Advanced Solid Tumors |
Estimated Enrollment: | 50 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Arm A: TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
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Drug: Topotecan Liposomes Injection (TLI)
TLI dose on Days 1 and 8 of a 21-day treatment cycle (Starting dose: 1 mg/m2)
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B: Experimental
Arm B: TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)
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Drug: Topotecan Liposomes Injection (TLI)
TLI dose on Day 1 of a 21-day treatment cycle (Starting dose: 2 mg/m2)
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Normal organ and marrow function as defined below within 14 days of study entry
Exclusion Criteria:
Contact: Michael Imperiale, MD | 6502285032 | michael.imperiale@hanabiosciences.com |
Contact: Jason R Lindow | 6502285038 | jason.lindow@hanabiosciences.com |
United States, Michigan | |
Barbara Ann Karmanos Cancer Center | Recruiting |
Detroit, Michigan, United States | |
Principal Investigator: Patricia LoRusso, MD | |
United States, Texas | |
South Texas Accelerated Research Therapeutics | Recruiting |
San Antonio, Texas, United States | |
Principal Investigator: Kyriakos Papadopoulos, MD |
Responsible Party: | Hana Biosciences, Inc. ( Michael Imperiale, MD ) |
Study ID Numbers: | HBS601 |
Study First Received: | October 1, 2008 |
Last Updated: | October 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00765973 |
Health Authority: | United States: Food and Drug Administration |
Other Advanced Solid Tumors |
Thoracic Neoplasms Ovarian cancer Ovarian Neoplasms Carcinoma, Neuroendocrine Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Neuroendocrine Tumors Carcinoma Carcinoma, Small Cell |
Genital Diseases, Female Neuroectodermal Tumors Respiratory Tract Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Lung Diseases Neuroepithelioma Endocrinopathy Topotecan Adenocarcinoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Respiratory Tract Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |
Therapeutic Uses Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions Adnexal Diseases |