Status:
COMPLETED
Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Cancer
Lead Sponsor:
INSYS Therapeutics Inc
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The primary purpose of this study is to identify a dose of Liposome Entrapped c-raf Antisense Oligonucleotide Easy-to-Use (LErafAON-ETU) which maximizes potential benefits of the compound to patients ...
Detailed Description
This Phase I, open-label, dose-escalation study is designed to determine the maximum tolerated dose of LErafAON-ETU in patients who have advanced cancer considered unresponsive to available, conventio...
Eligibility Criteria
Inclusion
- To be included in this study, patients must meet the following criteria:
- Be ≥18 years of age.
- Have advanced (local and/or metastatic) histologically documented cancer not considered responsive to available conventional modalities or treatment (i.e., no life prolonging therapy or therapy with a greater potential for patient benefit is available).
- Have an ECOG Performance status of 0-1.
- Have a life expectancy of \>12 weeks.
- Have recovered from acute toxicities of prior treatment: \*No treatment with radiotherapy or with cytotoxic or biologic agents within 3 weeks prior to study entry. At least 2 weeks must have elapsed since any prior surgery or granulocyte-stimulating growth factor therapy. Chronic treatment with non-investigational gonadotropin-releasing hormone agonists or other hormonal or supportive care is permitted. Concurrent bisphosphonate treatment is permitted if initiated ≥90 days prior to study entry. \*Chronic Grade 1 toxicities due to prior treatment or other causes are permitted.
- Be in adequate condition as evidenced by the following clinical laboratory values:
- Absolute neutrophil count (ANC) ≥1,500/mm³,
- Hemoglobin ≥9.0 g/dL,
- Platelets ≥125,000/mm³,
- PT, aPTT, creatinine, calcium, and total bilirubin ≤the institutional upper limit of normal (ULN),
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 x ULN,
- Alkaline phosphatase ≤2.5 x ULN
- Patients (male and female) must be willing to practice an effective method of birth control during the study.
- Patient must understand the investigational nature of this study and sign an Institutional Review Board (IRB) approved informed consent form prior to the performance of any study specific procedure.
Exclusion
- Patients are excluded from this study for the following:
- Active uncontrolled bleeding or bleeding diathesis (e.g., active peptic ulcer disease).
- Any active infection requiring parenteral or oral antibiotic treatment.
- Known infection with human immunodeficiency virus or hepatitis virus.
- Active heart disease including myocardial infarction within the previous 6 months, symptomatic coronary artery disease, arrhythmias currently requiring medication, or congestive heart failure.
- Known or suspected active central nervous system metastasis (patients stable 8 weeks after completion of treatment for central nervous system metastasis are eligible).
- Requiring immediate palliative treatment of any kind, including surgery and/or radiotherapy
- Concurrent anti-tumor therapy (except for chronic hormonal anti-tumor therapy).
- Treatment with any investigational drug within the 30-day period prior to enrollment in the study.
- Known hypersensitivity to any of the components of LErafAON-ETU.
- Prior treatment with LErafAON (previous sonicated formulation).
- Female patients who are pregnant or breast-feeding.
- Unwilling or unable to follow protocol requirements.
- Any consideration which in the Investigator's opinion deems the patient an unsuitable candidate to receive study drug.
Key Trial Info
Start Date :
December 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2010
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00100672
Start Date
December 1 2004
End Date
November 1 2010
Last Update
July 4 2011
Active Locations (2)
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1
premiere Oncology-Arizona
Scottsdale, Arizona, United States, 85260
2
Premiere Oncology-Santa Monica
Santa Monica, California, United States, 90404