A Study of the Safety, Effectiveness and Maximum Tolerated Dose of Oral PQR309 for Patients with Advanced Solid Tumors


About this study

The purpose of this study is to evaluate the safety, effectiveness and the maximum tolerable dose of PQR309 for the treatment of selected patients who have advanced solid tumors with known activation of AKT/PI3K/mTOR.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Histologically or cytologically confirmed diagnosis of solid malignancy, for which no standard curative or life prolonging therapy is available
  • Age ≥ 18
  • ECOG Performance Status of ≤ 1
  • Males and females of child-bearing potential must agree to use double-barrier contraceptive measures, oral contraception, or avoidance of intercourse during the study and for 90 days after last investigational drug dose received
  • Life expectancy of ≥ 12 weeks
  • Signed informed consent

Exclusion Criteria

  • Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy)
  • Major surgery within 14 days prior to starting study drug
  • Has poorly controlled diabetes mellitus, steroid-induced diabetes mellitus, or HbA1c > 7%
  • Is currently receiving warfarin for treatment, prophylaxis or otherwise
  • Has symptomatic congestive heart failure, myocardial infarction ≤ 6 months prior to enrolment, unstable angina pectoris, serious uncontrolled cardiac arrhythmia, symptomatic pericarditis, QTcB > 480 msec on the screening ECG
  • Pregnant or nursing (lactating)
  • Has any of the following mood disorders
    • Active major depressive episode
    • Bipolar disorder (I or II)
    • Obsessive-compulsive disorder
    • Schizophrenia
    • A history of suicidal attempt or ideation, or homicidal ideation
    • ≥ CTCAE Grade 3 anxiety
  • A history of interstitial pneumonitis or patients who require chronic oxygen

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Alex Adjei, M.D., Ph.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


Publications are currently not available

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