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

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ClinicalTrials.gov Identifier: NCT01940133
Recruitment Status : Completed
First Posted : September 12, 2013
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: PQR309 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: PQR309
Different dose evaluation
Drug: PQR309
Dosing will be orally, once a day for the duration of the trial.




Primary Outcome Measures :
  1. Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) [ Time Frame: In average 1 year ]

Secondary Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01940133


Locations
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Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
PIQUR Therapeutics AG
Investigators
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Study Chair: Andreas Wicki, Dr. University Hospital, Basel, Switzerland