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

Phase 1

Completed

• Conditions: Advanced Solid Tumors
• Interventions: Drug: PQR309

• Registration Number: NCT01940133
• Lead Sponsor: PIQUR Therapeutics AG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-09-06
• Study First Submitted QC: 2013-09-06
• Study First Posted: 2013-09-12
• Study Start: 2014-01
• Primary Completion: 2015-03
• Study Completion: 2015-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-10
• Last Update Posted: 2017-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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%.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PQR309	PQR309	Different dose evaluation

Primary Outcome Measures

Name	Time	Method
Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)	In average 1 year

Secondary Outcome Measures

Name	Time	Method
To determine overall safety	1 year	Incidence of SAEs, incidence and severity of all AEs, changes of vital signs, physical examinations, body weight, changes of routine laboratory assessments.

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland