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CompletedNCT01940133Updated Apr 12, 2017

A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309

A Phase 1 interventional study of PQR309 in Advanced Solid Tumors, sponsored by PIQUR Therapeutics AG. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-04-12.

Sponsored by PIQUR Therapeutics AG · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
28
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumors
03

In context

Lead sponsor

PIQUR Therapeutics AG is the lead sponsor of 8 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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%.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
28 participants (actual)

Study arms

  • Experimental
    PQR309

    Different dose evaluation

    Drug: PQR309

Interventions

  • DrugPQR309

    Dosing will be orally, once a day for the duration of the trial.

06

What researchers measure

Primary outcomes

  1. Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)

    Time frame: In average 1 year

Secondary outcomes

  1. To determine overall safety

    Incidence of SAEs, incidence and severity of all AEs, changes of vital signs, physical examinations, body weight, changes of routine laboratory assessments.

    Time frame: 1 year

07

Study locations

1 site
  • University Hospital Basel
    Basel, 4031, Switzerland
08

References and documents

Publications

  • 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. PubMed 29660598 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 12, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01940133
Lead sponsor
PIQUR Therapeutics AG
Responsible party
Sponsor
First posted
Sep 12, 2013
Start date
Jan 2014
Primary completion
Mar 2015
Completion
Dec 2015
Last update
Apr 12, 2017

Study contacts

Andreas Wicki, Dr.
study chair · University Hospital, Basel, Switzerland

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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