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Sponsored by: |
Onconova Therapeutics, Inc. |
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Information provided by: | Onconova Therapeutics, Inc. |
ClinicalTrials.gov Identifier: | NCT00856791 |
ON 01910.Na has undergone preclinical and clinical phase I studies showing activity in patients with progressing ovarian cancer resistant to platinum-based chemotherapies. This study will look at a larger population of patients to determine whether treatment with ON 01910.Na has an effect on progression free survival rates in patients with platinum-resistant ovarian cancer. ON 01910.Na will be given as an intravenous infusion over 2 hours on days 1, 4, 8, 11, 15, and 18 of a 28-day cycle. Patients will be treated for 6 or more cycles.
Condition | Intervention | Phase |
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Ovarian Cancer |
Drug: ON 01910.Na Concentrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Single-Arm Study of ON 01910.Na by 2-hr Infusion in Patients With Recurring Platinum-Resistant Ovarian Cancer |
Estimated Enrollment: | 37 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
This is a Phase II single arm study of ON 01910.Na to be administered as a 2-hour infusion biweekly to patients with progressive ovarian cancer resistant to platinum-based therapy.
The primary objective is to evaluate progression-free survival (PFS). The secondary objectives are to document other measures of outcome [objective response rate (ORR), duration of response, duration of stable disease, and overall survival (OS)], and tolerability of study drug.
Thirty-seven (37) patients with progressive ovarian cancer resistant to platinum-based therapy will be enrolled in a single arm study and treated with ON 01910.Na administered as a 2-hour infusion on Days 1, 4, 8, 11, 15 and 18 of a 28-day cycle. Patients will be treated until disease progression or withdrawal for other causes (unacceptable toxicity, patient or investigator decision) with ON 01910.Na. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v3.0). Progression-free survival, objective response, duration of response, and duration of stable disease will be assessed using RECIST guidelines, as well as overall survival. Grades 3 and 4 hematologic toxicities, grade >2 non-hematologic toxicities will be monitored. A futility analysis will be performed after 17 evaluable patients are enrolled and evaluated for overall objective response. If 3 or fewer objective response (CR and PR) are observed, the study will be closed to further accrual and deemed futile. An extension study for an additional 25 weeks with complete monitoring will be considered for patients who have not progressed by week 25.
The ON 01910.Na dose to be used in this study (2-hour infusions of 2400 or 3200 mg twice weekly for 3 weeks of a 4-week cycle) was selected based on the maximum tolerated doses and activities documented in phase 1 protocols.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Brain metastases including any of the following:
Contact: Andrew J. Park, PharmD | 609 799-7580 | apark@theradex.com |
United States, Indiana | |
St. Vincent Gynecologic Oncology | Recruiting |
Indianapolis, Indiana, United States, 46260 | |
Principal Investigator: Gregory P. Sutton, MD |
Principal Investigator: | Gregory P. Sutton, MD | St. Vincent Gynecologic Oncology, Indianapolis, IN |
Responsible Party: | Onconova Therapeutics, Inc. ( Francois E. Wilhelm, MD, PhD, Chief Medical Officer ) |
Study ID Numbers: | Onconova 04-12 |
Study First Received: | March 4, 2009 |
Last Updated: | March 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00856791 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Ovarian Cancer Cisplatin Carboplatin |
Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Carboplatin |
Recurrence Genital Diseases, Female Cisplatin Ovarian Cancer Endocrinopathy Endocrine Gland Neoplasms |
Genital Diseases, Female Neoplasms Neoplasms by Site Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female |
Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Adnexal Diseases Endocrine Gland Neoplasms |