Page 11 - Delaware Medical Journal - July-August 2018

CANCER CLINICAL TRIAL
PROTOCOL OF THE MONTH
A091304: A Phase I/Randomized Phase II Study of MLN0128 vs. Pazopanib in Patients with Locally
Advanced/Unresectable and/or Metastatic Sarcoma
The objectives of the trial are:
Primary Objective:
• Primary Phase I objective
To determine the safety and maximum tolerable dose of MLN0128 (TAK-228) within this patient population.
Secondary Objective:
• To evaluate adverse events.
• To evaluate Overall Response Rate (ORR), Clinical Benefit Rate (CBR), and Duration of Response (DOR). • To evaluate Time to Progression (TTP) and Overall Survival (OS).
Pre-Registration Eligibility Criteria (Step 0)
• Central pathology review submission
Registration Eligibility Criteria (Step 1)
• Histologic Documentation and Measurable Disease
Prior Treatment
• Progression on at least one prior systemic chemotherapy for advanced, unresectable or metastatic disease. Prior adjuvant or neoadjuvant therapy is not included as prior systemic chemotherapy unless treatment occurred within the 6 months prior to study enrollment.
• There is no limit to the number of prior lines of treatment a patient has received.
• No treatment with biological therapy, immunotherapy, chemotherapy, investigational agent for malignancy, or radiation ≤ 28 days before study registration. No treatment with nitrosourea or mitomycin ≤ 42 days before study registration.
• No treatment with radiation therapy ≤ 28 days before study registration.
• Patients should have resolution of any toxic effects of prior therapy (except alopecia) to NCI CTCAE, Version 4.0, grade 1 or less.
• Prior treatment with pazopanib or any PI3K, mTOR, AKT, or dual PI3K/mTOR complex (TORC1/TORC2) inhibitors will be prohibited.
• Age ≥18, ECOG performance status ≤ 1, and Not pregnant and not nursing
• Parameter use for chronic concomitant treatment with proton pump inhibitors, treatment with strong inhibitors of CYP3A4 inhibitors, or chronic concomitant treatment with strong CYP3A4 inducers.
• Required Initial Laboratory Values
Treatment: PHASE I
ARM 1: TAK 228 30mg weekly till progression
ARM 2: Pazopanib 800mg PO once daily (If progression occurs, may cross over to Arm 1)
For information regarding this clinical trial or if you would like to have the list of open protocols emailed to you, please call the Cancer Research Office at (302) 623-4450 or email akee@christianacare.org.
Del Med J | July/August 2018 | Vol. 90 | No. 6 183