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| Sponsor: | Fox Chase Cancer Center |
|---|---|
| Collaborators: |
National Comprehensive Cancer Network GlaxoSmithKline |
| Information provided by (Responsible Party): | Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01462630 |
Purpose
The purpose of this study is to find out what effects, good and/or bad, pazopanib has on you and your angiosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Angiosarcoma |
Drug: Pazopanib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase II Study Evaluating the Role of Pazopanib in Angiosarcoma |
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Pazopanib has shown encouraging activity in a previous phase II trial in certain sarcoma subtypes. In the phase II trial of pazopanib as described above, conducted by the EORTC, the progression free rate at 12 weeks exceeded 40% for patients with leiomyosarcomas, synovial cell sarcomas, and other eligible sarcomas, but not liposarcomas. In the group of other sarcomas, five were described as vascular sarcomas.
The investigators hypothesize that pazopanib will have therapeutic activity in angiosarcoma because they are derived from endothelial cells, and pazopanib is an anti-angiogenic agent. In addition, agents with anti-angiogenic properties have shown single agent activity in this disease. Sorafenib has been shown to have a 14% response rate in angiosarcomas in previously treated patients in the phase II setting. Bevacizumab has demonstrated a 12% response rate [12]. Given the limited data on the activity of pazopanib in angiosarcomas, the investigators propose to evaluate its activity in patients with angiosarcoma.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Non-childbearing potential (i.e., physiologically incapable of becoming pregnant), including any female who has had:
Subjects not using hormone replacement therapy (HRT) must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years in age, OR, in questionable cases, have a follicle stimulating hormone (FSH) value > 40 mIU/mL and an estradiol value < 40pg/mL (< 140 pmol/L).
Subjects using HRT must have experienced total cessation of menses for ≥ 1 year and be greater than 45 years of age OR have had documented evidence of menopause based on FSH and estradiol concentrations prior to initiation of HRT
Childbearing potential, including any female who has had a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment and for 3 months after the completion of treatment, preferably as close to the first dose as possible, and agrees to use adequate contraception. Acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject.
tuble barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository) Female subjects who are lactating must discontinue nursing prior to the first dose of study drug and refrain from nursing throughout the treatment period and for 14 days following the last dose of study drug
Exclusion Criteria:
Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for GI bleeding including, but not limited to:
Clinically significant GI abnormalities that may affect absorption of investigational product including, but not limited to:
History of any one or more of the following cardiovascular conditions within the past 6 months:
Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. Following antihypertensive medication initiation or adjustment, blood pressure (BP) must be re-assessed three times at approximately 2-minute intervals. At least 24 hours must have elapsed between anti-hypertensive medication initiation or adjustment and BP measurement. These three values will be averaged to obtain the mean diastolic blood pressure and the mean systolic blood pressure. The mean SBP / DBP ratio must be < 140/90 mmHg in order for a subject to be eligible for the study.
- Cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
Note: Subjects with recent DVT who have been therapeutically coagulated for at least 6 weeks are eligible.
Treatment with any of the following therapies:
Contacts and Locations| Contact: Margaret von Mehren, MD | 215-728-2460 | margaret.vonmehren@fccc.edu |
| Contact: Beth Adair-Halenda, CCRP | 215-214-3704 | beth.adaire@fccc.edu |
| United States, Pennsylvania | |
| Fox Chase Cancer Center | Recruiting |
| Philadelphia, Pennsylvania, United States, 19111 | |
| Contact: Margaret von Mehren, MD 215-728-2814 Margaret.vonMehren@fccc.edu | |
| Principal Investigator: Margaret von Mehren, MD | |
| Principal Investigator: | Margaret von Mehren, MD | Fox Chase Cancer Center |
More Information
| Responsible Party: | Fox Chase Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01462630 History of Changes |
| Other Study ID Numbers: | OER-SAR-043 |
| Study First Received: | October 27, 2011 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
Hemangiosarcoma Sarcoma Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Neoplasms, Vascular Tissue |