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Completed

NCT Number: NCT01940133

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

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.

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Key information

Conditions

Advanced Solid Tumors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%.

Treatment and study plan

PQR309

Drug

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

Primary outcomes

  1. Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)

    Time frame: In average 1 year

Secondary outcomes

  1. To determine overall safety

    Time frame: 1 year

    Incidence of SAEs, incidence and severity of all AEs, changes of vital signs, physical examinations, body weight, changes of routine laboratory assessments.

Sponsors and collaborators

Lead sponsor

PIQUR Therapeutics AG

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 12, 2013
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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