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A Phase I/Randomized Phase II Study of MLN0128 (TAK-228) vs. Pazopanib in Patients with Locally Advanced/Unresectable and/or Metastatic Sarcoma.

Research & Trial Information

SCHEMA A091304

Protocol #: A091304

Cancer Type: Sarcoma

Eligibility Criteria:

  1. Eligible patients must have histopathologically confirmed sarcoma.
  2. Locally advanced or metastatic disease. Locally advanced disease is defined as disease not amenable to local therapy such as surgery and/or radiation.
  3. Measurable disease.
  4. 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. Prior treatment with pazopanib or any PI3K, mTOR, AKT, or dual PI3K/mTOR complex (TORC1/TORC2) inhibitors will be prohibited.
  5.  Age ≥ 18 years.
  6. ECOG Performance Status ≤ 1.
  7. Chronic concomitant treatment with proton pump inhibitors must discontinue the drug for 7 days prior to registration on the study.
  8. Patient history: patients who have any of the following are NOT eligible: CNS: Symptomatic, untreated, or uncontrolled brain metastases present. Heme: Active bleeding or bleeding diathesis. Abdominal fistula, GI perforation, or intra-abdominal abscess within 28 days prior to registration. Acute GI bleed within 28 days of registration. Diabetes Mellitus. Cardiac and Vascular Disorders.
  9. Chronic concomitant treatment with proton pump inhibitors must discontinue the drug for 7 days prior to registration on the study.
  10. Chronic concomitant treatment with strong inhibitors of CYP3A4 inhibitors must discontinue the drug for 14 days prior to registration on the study.’
  11. Chronic concomitant treatment with strong CYP3A4 inducers is not allowed. Patients must discontinue the drug 14 days prior to the start of study treatment.

 

 

Ⓒ 2018 Genesys Hurley Cancer Institute | All Rights Reserved.

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