Clinical trial · Interventional
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309
Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors
NCT01940133CI-TRIAL-00026935completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is a Phase I, open label study to determine the Maximum Tolerated Dose(MTD) and the Recommended Phase II Dose (RP2D) in patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PQR309 | Drug | Bimiralisib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PQR309
- description
- Different dose evaluation
- interventionNames
- Drug: PQR309
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)
- timeFrame
- In average 1 year
Secondary outcomes (1)
- measure
- To determine overall safety
- timeFrame
- 1 year
- description
- Incidence of SAEs, incidence and severity of all AEs, changes of vital signs, physical examinations, body weight, changes of routine laboratory assessments.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced solid tumor for which no therapy of proven efficacy is available. * Age ≥ 18 * Evidence of tumor progression with measurable or evaluable disease. * Use of adequate contraceptive measures for male patients. * Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1. * Signed informed consent. Exclusion Criteria: * Concomitant anticancer therapy (e.g., chemotherapy, radiotherapy, hormonal, immunotherapy, biological response modifier, signal transduction inhibitors) * Patients with a history of myocardial infarction or coronary artery bypass within the last 3 years. * Patients with severe/unstable angina, coronary/peripheral arterial bypass, symptomatic congestive heart failure NYHA Class 3 or 4, hypertension BP\>150/100mmHg. * Pre-diagnosed diabetes mellitus. * Fasting glucose \> 7.0 mmol/L or HbA1c \> 6%.
References
Publications (1)
- DERIVEDWicki A, Brown N, Xyrafas A, Bize V, Hawle H, Berardi S, Cmiljanovic N, Cmiljanovic V, Stumm M, Dimitrijevic S, Herrmann R, Pretre V, Ritschard R, Tzankov A, Hess V, Childs A, Hierro C, Rodon J, Hess D, Joerger M, von Moos R, Sessa C, Kristeleit R. First-in human, phase 1, dose-escalation pharmacokinetic and pharmacodynamic study of the oral dual PI3K and mTORC1/2 inhibitor PQR309 in patients with advanced solid tumors (SAKK 67/13). Eur J Cancer. 2018 Jun;96:6-16. doi: 10.1016/j.ejca.2018.03.012. Epub 2018 Apr 13. PMID 29660598