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Pazopanib in Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors (GIST)

This study has been terminated.
(Lack of efficacy - Futility endpoint reached)
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Kristen Ganjoo, Stanford University
ClinicalTrials.gov Identifier:
NCT01391611
First received: July 8, 2011
Last updated: February 22, 2017
Last verified: December 2016
  Purpose

This study is being done to gather information about the safety (any harmful effects) and effectiveness (usefulness) of Pazopanib in the treatment of Gastrointestinal Stroma Tumors (GIST) that cannot be treated by surgery or has spread to other organs. The Food and Drug Administration (FDA) have approved Pazopanib for the treatment of advanced kidney cancer but it is not approved for the treatment of GIST. The investigators hope to learn about the safety and usefulness (effectiveness) of Pazopanib for patients with GIST.

Primary Objective:

Non-progression rate based on RECIST criteria (CR+PR+SD)

Secondary Objectives:

  • Response per Choi criteria
  • 6 month progression-free survival
  • Safety and tolerability

Condition Intervention Phase
Gastrointestinal Stromal Tumor (GIST)
Drug: Pazopanib
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase II Study of Pazopanib in Patients With Imatinib Refractory or Intolerant Gastrointestinal Stromal Tumors (GIST)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Non-progression Rate Based on RECIST 1.0 Criteria (CR+PR+SD) [ Time Frame: 24 weeks ]

    4-mo non-progression rate

    "Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression



Secondary Outcome Measures:
  • Response Per Choi Criteria [ Time Frame: 6 months ]

    Response per Choi criteria

    • Complete response - Disappearance of all lesions; no new lesion
    • Partial response - A decrease in size of > or = 10% or a decrease in tumor density (HU) > or = 15% on CT. No new lesions. No obvious progression of nonmeasurable disease.
    • Stable disease - Does not meet the criteria for CR, PR, or PD. No symptomatic deterioration attributed to tumor progression.
    • Progressive disease - An increase in tumor size of > or = 10% and does not meet criteria of PR by tumor density (HU) on CT. New lesions. New intratumoral nodules or increase in the size of the existing intratumoral nodules.


Enrollment: 25
Study Start Date: July 2011
Study Completion Date: December 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pazopanib arm Drug: Pazopanib
800 mg; PO
Other Name: Votrient

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Metastatic or unresectable gastrointestinal stromal tumor (GIST)
  • Failure or intolerance to Imatinib and sunitinib
  • Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.
  • Procedures conducted as part of the subject's routine clinical management (e.g., blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
  • Age >= 18 years
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Measurable disease criteria by RECIST criteria
  • Adequate organ system function as defined in protocol.
  • A female is eligible to enter and participate in this study if she is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant). This includes any female who has had:
  • A hysterectomy
  • A bilateral oophorectomy (ovariectomy)
  • A bilateral tubal ligation
  • Menopause
  • Childbearing potential females must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agree to use adequate contraception. Adequate acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
  • An intrauterine device with a documented failure rate of less than 1% per year.
  • Vasectomized partner who is sterile prior to the female subject?s entry and is the sole sexual partner for that female.
  • Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product.

Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide edify eligible disease(s)/stage(s)

Exclusion Criteria:

  • History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer
  • Clinically significant gastrointestinal abnormalities that may affect absorption of the investigational product
  • Presence of uncontrolled infection
  • Prolongation of corrected QT interval (QTc) > 480 milliseconds. On antiarrhythmics or medications known to prolong QT interval
  • History of any one or more of the following cardiovascular conditions within the past 6 months:
  • Cardiac angioplasty or stenting
  • Myocardial infarction
  • Unstable angina
  • Coronary artery by-pass graft surgery
  • Symptomatic peripheral vascular disease
  • Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
  • Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >=140 mmHg or diastolic blood pressure (DBP) of >= 90mmHg].
  • History of cerebrovascular accident, hemoptysis, cerebral hemorrhage, clinically significant GI bleed, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
  • Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture
  • Evidence of active bleeding or bleeding diathesis.
  • 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 procedures.
  • Patients on strong CYP3A4 inhibitors
  • Uncorrected abnormal electrolytes- K, Mg and Ca
  • Treatment with any of the following anti-cancer therapies:
  • o radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
  • o chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391611

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Kristen Ganjoo
GlaxoSmithKline
Investigators
Principal Investigator: Kristen N. Ganjoo Stanford University
  More Information

Responsible Party: Kristen Ganjoo, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT01391611     History of Changes
Other Study ID Numbers: IRB-20636
RR2002/00017/09 ( Other Identifier: GlaxoSmithKline )
11-311 ( Other Identifier: Stanford IRB alternate )
GIST0003 ( Other Identifier: OnCore )
Study First Received: July 8, 2011
Results First Received: December 19, 2016
Last Updated: February 22, 2017

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Imatinib Mesylate
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017