test

A Phase II Study of Hsp90 Inhibitor AUY922 for the Treatment of Patients with Refractory Gastrointestinal Stromal Tumor

Conditions

Cancer | Other Digestive Organ

Trial Phase

Phase II

Trial Purpose and Description

Trial Purpose

To determine the progression-free survival (PFS) of patients with refractory GIST treated with AUY922.


Participation Guidelines

Age:
18 Years and older
Gender:
Both

Eligibility Criteria

Inclusion Criteria:

  • Patients with histologically-confirmed metastatic or unresectable GIST who have progressed on, are intolerant of, or are not a candidate for imatinib and sunitinib therapy. Patients must not have received prior treatment with Hsp90 inhibitors.
  • Patient must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
  • Patient must have a life expectancy of >3 months.
  • Patient must have at least one unidimensional measurable lesion definable by MRI or CT scan. Disease must be measurable per Responsive Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Patients must have normal serum phosphorus and magnesium > the lower limit of normal (LLN) prior to trial entry.
  • Normal bone marrow function defined as: Absolute neutrophil count (ANC) >1500/L, Hemoglobin (Hgb) > 9 g/dL, Platelets >100,000/mL.
  • Adequate hepatic function defined as: AST or ALT and alkaline phosphatase (ALP) must be 2.5 x ULN, or <5 x ULN in patients with liver metastases, Total bilirubin <1.5 x the institutional ULN
  • Renal function defined as: Serum creatinine <1.5 x ULN or 24-hour creatinine clearance >50 mL/min.
  • Women of childbearing potential must have a negative serum or urine pregnancy test performed <7 days prior to start of treatment. Women of childbearing potential or men with partners of childbearing potential must use effective birth control measures during treatment and during the 6 months following completion of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
  • Patients must be ³ 18 years-of-age.
  • Patients must be accessible for treatment and follow-up.
  • Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.

Exclusion Criteria:

  • Currently receiving or have received cancer therapies < 21 days of initiating study therapy (including radiation therapy, biologic therapy, hormonal therapy, or chemotherapy). For patients receiving small molecule targeted therapy, study treatment may begin > 21 days after last dose or >5 half lives of previous treatment, whichever is shorter. The patient must have recovered from or come to a new chronic stable baseline from all treatment-related toxicities.
  • Use of any non-approved or investigational agent <30 days (or within 5 half lives, whichever is shorter, as long as acute side effects have resolved or come to a new stable baseline) of administration of the first dose of study drug. Patients may not receive any other investigational or anti-cancer treatments while participating in this study.
  • Uncontrolled brain metastases. Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at > 2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued.
  • Treatment with therapeutic doses of coumadin-type anticoa.
  • Known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
  • Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Women who are pregnant (positive pregnancy test) or lactating.
  • Any condition that would prevent patient comprehension of the nature of, and risk associated with, the study, and the inability to comply with study and/or follow-up procedures.
  • Other malignancies <3 years, with the exception of adequately treated basal or squamous cell carcinomas of the skin, carcinoma in situ of the cervix, or localized prostate cancer with a current PSA of <1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry.
Sponsor:
Sarah Cannon Research Institute Oncology Research Consortium
Dates:
07/30/2013
Last Updated:
Study HIC#:
1301011364