Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma
This study is currently recruiting participants.
Verified May 2013 by ACORN Research, LLC
Sponsor:
ACORN Research, LLC
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ACORN Research, LLC
ClinicalTrials.gov Identifier:
NCT01330966
First received: April 6, 2011
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
The purpose of this study is to determine the effectiveness and safety of single agent pazopanib in subjects with chondrosarcoma.
| Condition | Intervention | Phase |
|---|---|---|
|
Chondrosarcoma Metastatic Chondrosarcoma |
Drug: pazopanib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma |
Resource links provided by NLM:
Further study details as provided by ACORN Research, LLC:
Primary Outcome Measures:
- Disease control at week 16 [ Time Frame: Assessed at week 16 of study treatment ] [ Designated as safety issue: No ]Disease control at week 16 defined as complete response (CR) plus partial response (PR) plus stable disease (SD) where tumor response is defined by RECIST (Response Evaluation Criteria in Solid Tumors) guidelines version 1.1. Repeat radiologic imaging is performed after every 2 cycles of treatment (approximately every 8 weeks).
Secondary Outcome Measures:
- Toxicity [ Time Frame: Continuously from the start of study treatment (Cycle 1 day 1) until 30 days after the end of treatment ] [ Designated as safety issue: Yes ]Toxicity will be assessed continuously during study participation through the reporting of adverse events (AEs) using the CTCAE (Common Terminology Criteria for Adverse Events)version 4.0
- Progression free survival (PFS) [ Time Frame: Cycle 1 day 1 until the subject experiences disease progression ] [ Designated as safety issue: No ]The time origin for PFS will be cycle 1 day 1. Repeat radiologic imaging will be conducted after every 2 cycles of treatment (approximately every 8 weeks).
- Overall survival (OS) [ Time Frame: Cycle 1 day 1 until the subject dies, is lost to follow-up, or withdraws consent ] [ Designated as safety issue: No ]The time origin for OS will be cycle 1 day 1. Subjects will be followed until death, lost to follow-up, or withdrawal of consent.
| Estimated Enrollment: | 47 |
| Study Start Date: | April 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: pazopanib
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
|
Drug: pazopanib
Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
Other Name: Votrient
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Written informed consent
- Age > or = to 18 years
- Histologically confirmed diagnosis of conventional chondrosarcoma of any grade
- Surgically unresectable or metastatic disease
- Any number of prior treatment regimens, including treatment naive subjects
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
- Measurable or evaluable (non-measurable) disease per RECIST guidelines version 1.1
- Adequate organ system function determined within 14 days prior to first dose of study treatment
- Females must either be of non-child bearing potential or have a negative serum pregnancy test within 7 days prior to the first dose of study treatment
Exclusion Criteria:
- Mesenchymal, dedifferentiated, and extraskeletal myxoid chondrosarcoma subtypes
- Prior malignancy (Note: subjects who have had another malignancy and have been disease-free for 3 years, or subjects with a history of completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma are eligible)
- History or clinical evidence of central nervous system metastases or leptomeningeal carcinomatosis
- Clinically significant gastrointestinal (GI) abnormalities that may increase the risk for GI bleeding
- Clinically significant GI abnormalities that may affect absorption of investigational product
- Presence of uncontrolled infection
- Corrected QT interval > 480 msecs using Bazett's formula
- History of certain cardiovascular conditions within the past 6 months
- Poorly controlled hypertension [defined as systolic blood pressure of > or = 140 mmHg or diastolic blood pressure of > or = 90 mmHg]
- History of cerebrovascular accident including transient ischemic attack, pulmonary embolism, or untreated deep venous thrombosis within the past 6 months
- Prior major surgery or trauma within 28 days prior to the first dose of study drug and/or presence of any non-healing wound, fracture, or ulcer
- Evidence of active bleeding or bleeding diathesis
- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels
- Hemoptysis in excess of 2.5 mL within 8 weeks of first dose of study drug
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures
- Unable or unwilling to discontinue use of prohibited medications for at least 14 days prior to the first dose of study drug and for the duration of study treatment
- Radiation therapy, surgery (except major surgery), tumor embolization, chemotherapy, immunotherapy, biologic therapy, investigational therapy, or hormonal therapy within 14 days prior to the first dose of study drug
- Any ongoing toxicity from prior anti-cancer therapy that is > Grade 1 and/or that is progressing in severity, except alopecia
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01330966
Contacts
| Contact: Stacey R Stephenson | 901-435-5574 | sstephenson@acorncro.com |
Locations
| United States, California | |
| City of Hope | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Gina Avenido 626-256-4673 ext 32074 gavenido@coh.org | |
| Principal Investigator: Warren Chow, MD | |
| United States, Illinois | |
| Edward Cancer Center | Recruiting |
| Naperville, Illinois, United States, 60540 | |
| Contact: Kathy Seymour 630-646-6072 kseymour@edward.org | |
| Principal Investigator: Samir Undevia, MD | |
| United States, Iowa | |
| University of Iowa | Recruiting |
| Iowa City, Iowa, United States, 52242 | |
| Contact: Regina Arthur 319-335-9575 regina-arthur@uiowa.edu | |
| Principal Investigator: Mohammed Milhem, MD | |
| United States, Minnesota | |
| Mayo Clinic | Recruiting |
| Rochester, Minnesota, United States, 55905 | |
| Contact 507-538-7623 | |
| Principal Investigator: Scott Okuno, MD | |
| United States, Pennsylvania | |
| Pennsylvania Oncology Hematology Associates | Recruiting |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Contact: Jennifer King, RN 215-829-6043 jenniferking@pennoncology.com | |
| Principal Investigator: Arthur Staddon, MD | |
| United States, Texas | |
| MD Anderson | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Joanne Gigstad 713-563-0510 jgigstad@mdanderson.org | |
| Principal Investigator: Dejka M. Araujo, MD | |
Sponsors and Collaborators
ACORN Research, LLC
GlaxoSmithKline
Investigators
| Study Chair: | Arthur Staddon, MD | Pennsylvania Oncology Hematology Associates |
| Study Chair: | Warren Chow, MD | Beckman Research Institute |
More Information
No publications provided
| Responsible Party: | ACORN Research, LLC |
| ClinicalTrials.gov Identifier: | NCT01330966 History of Changes |
| Other Study ID Numbers: | ACORN AAPSMCS1002 |
| Study First Received: | April 6, 2011 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by ACORN Research, LLC:
|
surgically unresectable chondrosarcoma |
Additional relevant MeSH terms:
|
Chondrosarcoma Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue |
Neoplasms by Histologic Type Neoplasms Sarcoma |
ClinicalTrials.gov processed this record on June 18, 2013