phase 2 - MK-2206 in the Treatment of Recurrent Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer - Full Text View - ClinicalTrials.gov

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

• To assess the activity of MK-2206 in patients with recurrent grade 2 or 3 platinum-resistant serous ovarian, fallopian tube, or peritoneal cancer [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  To assess the activity of MK-2206 in patients with recurrent grade 2 or 3 platinum-resistant serous ovarian, fallopian tube, or peritoneal cancer, as measured by the frequency of patients experiencing an objective tumor response by RECIST criteria or who survive progression-free for at least 6 months after initiation of therapy
  
  

Secondary Outcome Measures:

• To assess the progression-free and overall survival following initiation of therapy with MK-2206 in the cohort of subjects enrolled on this study [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  
• To determine the toxicities of MK-2206, as assessed by the active version of the NCI Common Toxicity Criteria (CTCAE v4.0) [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  
• To explore the association between select biomarkers and response to MK-2206 (as assessed by objective tumor response, progression-free survival, and overall survival) [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  
• To explore the development of feedback loop activation and target inhibition with MK-2206 via analysis of pre-treatment and post-treatment biopsies in select patients enrolled in the trial [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Criteria

Inclusion Criteria:

• Grade 2 or 3 ovarian, fallopian tube, or primary peritoneal cancer
• Evidence of a defect in the P13K/AKT pathway
• Prior platinum-based chemotherapy
• Life expectancy > 6 months
• Normal organ and marrow function
• Toxicities from prior therapy resolved
• Able to tolerate oral medications

Exclusion Criteria:

• Pregnant or breastfeeding
• Receiving other study agents
• Brain metastases
• Subjects requiring insulin for control of hyperglycemia
• Prolonged QTc interval
• Preexisting significant heart block or bradycardia due to cardiac disease
• Uncontrolled intercurrent illness
• Bowel obstruction
• Dependency on IV hydration or TPN
• History of a different malignancy unless disease free for the last 5 years
• HIV-positive on combination antiretroviral therapy