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

NCT ID: NCT01940133

Last Updated: 2017-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2015-12-31

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PQR309

Different dose evaluation

Group Type: EXPERIMENTAL

PQR309

Intervention Type: DRUG

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

Interventions

PQR309

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

Intervention Type: DRUG

Eligibility Criteria

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%.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

PIQUR Therapeutics AG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Wicki, Dr.

Role: STUDY_CHAIR

University Hospital, Basel, Switzerland

Locations

University Hospital Basel

Basel, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 29660598 (View on PubMed)

Other Identifiers

2013-003441-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PQR309-001

Identifier Type: -

Identifier Source: org_study_id