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A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chondrosarcoma, Metastatic Chondrosarcoma

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Trial Information

A Phase II Study of Pazopanib in the Treatment of Surgically Unresectable or Metastatic Chondrosarcoma


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease control at week 16

Outcome Description:

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).

Outcome Time Frame:

Assessed at week 16 of study treatment

Safety Issue:

No

Principal Investigator

Arthur Staddon, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Pennsylvania Oncology Hematology Associates

Authority:

United States: Institutional Review Board

Study ID:

ACORN AAPSMCS1002

NCT ID:

NCT01330966

Start Date:

April 2011

Completion Date:

September 2014

Related Keywords:

  • Chondrosarcoma
  • Metastatic Chondrosarcoma
  • surgically unresectable chondrosarcoma
  • Chondrosarcoma

Name

Location

University of IowaIowa City, Iowa  52242
Mayo ClinicRochester, Minnesota  55905
Pennsylvania Oncology Hematology AssociatesPhiladelphia, Pennsylvania  19107
City of HopeDuarte, California  91010
Edward Cancer CenterNaperville, Illinois  60540
MD AndersonHouston, Texas  77230