A Study to Identify a Biomarker Predictive for Response on Everolimus in Solid Tumors (CPCT-03)

Inclusion criteria

• Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow-up
• Inclusion in the CPCT-02 study
• Age ≥ 18 years
• Diagnosis of malignant tumor showing progressive disease according to investigators opinion
• WHO performance status of (0-2)
• Measurable disease allowing for volumetric measurements
• No availability of standard of care systemic treatment options or patient refuses to receive standard of care chemotherapy treatment
• A female is eligible to enter and participate in this study if she is of: Non-childbearing potential
• Adequate organ system function as defined in the protocol
• Fasting serum cholesterol ≤ 300 mg/dl or 7.75 mmol/L and fasting triglycerides ≤ 2.5 × ULN.

Exclusion criteria

• Previous treatment with mTOR inhibitors/pi3k inhibitors/AKT inhibitors
• Uncontrolled hypertension defined as RR > 160/95 mmHg
• Serious non-healing wound, ulcer or bone fracture
• Within 7 days of surgery (including minor procedures)
• Known and/or symptomatic intracerebral metastases
• Pregnancy or breast feeding, reproductive potential not using effective birth control methods
• Severe medical condition(s) prohibiting participation in the study
• Use of other investigational agents now or last 28 days prior to study treatment start
• Unable or unwilling to discontinue use of interacting medications or modify the dosing of interacting drugs for at least 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of study drug and for the duration of the study
• Less than four weeks after regular treatment/ palliative radiotherapy
• Prolongation of Fridericia corrected QT interval (QTcF) > 480 milliseconds
• Any severe and / or uncontrolled medical conditions such as:

• Unstable angina pectoris, symptomatic congestive heart failure myocardial infarction ≤6 months prior to enrollment, serious uncontrolled cardiac arrhythmia
• Uncontrolled diabetes as defined by fasting serum glucose > 1.5 × ULN
• Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
• Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs
• Significant symptomatic deterioration of lung function.
• Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin and acetylsalicylic acid or equivalent, as long as the INR is < 2.0)
• Patients with a known history of HIV seropositivity
• Patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A within the last 5 days prior to enrollment
• Patients receiving concomitant immunosuppressive agents or chronic corticosteroids use, at the time of study entry except in cases outlined below:

• Topical applications (e.g. rash)
• Inhaled sprays (e.g. obstructive airways diseases),
• Eye drops
• Local injections (e.g. intra-articular) are allowed.
• Patients on stable low dose of corticosteroids for at least two weeks before enrollment are allowed in case of treatment of brain metastases .