A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309
Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors
2 other identifiers
interventional
28
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 6, 2013
CompletedFirst Posted
Study publicly available on registry
September 12, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedApril 12, 2017
April 1, 2017
1.2 years
September 6, 2013
April 10, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)
In average 1 year
Secondary Outcomes (1)
To determine overall safety
1 year
Study Arms (1)
PQR309
EXPERIMENTALDifferent dose evaluation
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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%.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Basel
Basel, 4031, Switzerland
Related Publications (1)
Wicki 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: 29660598DERIVED
Study Officials
- STUDY CHAIR
Andreas Wicki, Dr.
University Hospital, Basel, Switzerland
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 6, 2013
First Posted
September 12, 2013
Study Start
January 1, 2014
Primary Completion
March 1, 2015
Study Completion
December 1, 2015
Last Updated
April 12, 2017
Record last verified: 2017-04