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

Advanced Solid Tumors Clinical Trial

Official title:

Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940133
• Other study ID #: PQR309-001
• Secondary ID: 2013-003441-42
• Status: Completed
• Phase: Phase 1
• First received: September 6, 2013
• Last updated: April 10, 2017
• Start date: January 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2017
• Source: PIQUR Therapeutics AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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%.

Related Conditions & MeSH terms

• Advanced Solid Tumors

Intervention

Drug:
• PQR309
Dosing will be orally, once a day for the duration of the trial.

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
PIQUR Therapeutics AG

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)		In average 1 year
Secondary	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.	1 year