Page 12 - Delaware Medical Journal - July 2016
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CANCER CLINICAL TRIAL
NCI PROTOCOL OF THE MONTH
Alliance A091304: A Phase I/Randomized Phase II Study of MLN0128 vs. Pazopanib in Patients with Locally Advanced/Unresectable and/or Metastatic
S arcoma Primary Phase I Objective:
To determine the safety and maximum tolerable dose of MLN0128 within this patient population.
Primary Phase II Objective:
To determine the differences in progression-free survival (PFS) in patients with sarcoma who receive MLN0128 as compared to pazopanib.
Secondary Phase I/II Objectives:
To evaluate adverse events.
To evaluate Time to Progression (TTP) and Overall Survival (OS).
Exploratory Phase II Objectives:
To evaluate PFS and secondary endpoints within patients crossing over to MLN0128, upon disease progression during treatment with pazopanib.
Eligibilty:
STEP 0 Registration
Patients must have a FFPE tumor block OR 1 representative H&E and 20 unstained sarcoma tissue slides available for submission to
STEP 1 Registration
prior to registration.
Treatment:
weekly on days 1, 8, 15, and 22 over a 28 day cycle. Patients may remain on treatment until disease progression, unacceptable toxicity, or withdrawal of consent.
The Delaware Cancer Treatment Program (DCTP) provides medical insurance coverage to uninsured Delawareans for the treatment of cancer. Call 302-7441040 for more information.
Or
Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of consent.
For information regarding clinical trials
or if you would like to have the list of open protocols e-mailed to you, akee@christianacare.org.
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