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

PIQUR Therapeutics

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: PQR309

Study type

Interventional

Funder types

Industry

Identifiers

NCT01940133

2013-003441-42 (EudraCT Number)

PQR309-001

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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%.