Trial | NCT01940133  Report issue

Title

A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309
Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pqr309 ...

  • Study Participants

    28
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.
Study Started
Jan 31
2014
Primary Completion
Mar 31
2015
Study Completion
Dec 31
2015
Last Update
Apr 12
2017

Drug PQR309

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

PQR309 Experimental

Different dose evaluation

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%.
No Results Posted