Advanced Solid TumorsPhase 1NCT01940133
A Study to Investigate Safety, Pharmacokinetics (PK) and Pharmacodynamics (PD) of PQR309
A Phase 1 study testing PQR309 in people with Advanced Solid Tumors, run by PIQUR Therapeutics AG at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- PQR309
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2014to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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%.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- PQR309
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PQR309Drug
Dosing will be orally, once a day for the duration of the trial.
| Study group | Role | What they receive |
|---|---|---|
| PQR309 | Experimental | Different dose evaluation Receives: Drug: PQR309 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)
Measured: In average 1 year
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- PIQUR Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andreas Wicki, Dr., Study chair, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940133
- Sponsor's protocol ID
- PQR309-001
- Other IDs
- 2013-003441-42
- Status last verified
- Apr 2017
- First submitted
- 6 Sep 2013
- Last updated
- 12 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wicki A, Brown N, Xyrafas A, Bize V, Hawle H, Berardi S, Cmiljanovic N, Cmiljanovic V, Stumm M, Dimitrijevic S, Herrmann R, Pretre V, Ritschard R, Tzankov A, Hess V, Childs A, Hierro C, Rodon J, Hess D, Joerger M, von Moos R, Sessa C, Kristeleit R. First-in human, phase 1, dose-escalation pharmacokinetic and pharmacodynamic study of the oral dual PI3K and mTORC1/2 inhibitor PQR309 in patients with advanced solid tumors (SAKK 67/13). Eur J Cancer. 2018 Jun;96:6-16. doi: 10.1016/j.ejca.2018.03.012. Epub 2018 Apr 13.
PubMed 29660598
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01940133
- Acronym / sponsor ID
- PQR309-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- PIQUR Therapeutics AGIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PQR309 | Experimental | Drug: PQR309Different dose evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- 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%.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PQR309Dosing will be orally, once a day for the duration of the trial. | Drug | PQR309 |
Primary outcome
Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D)
Time frame: In average 1 year
1 secondary outcome
To determine overall safety
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
- Derived from this study: PubMed 29660598Wicki A, Brown N, Xyrafas A, Bize V, Hawle H, Berardi S, Cmiljanovic N, Cmiljanovic V, Stumm M, Dimitrijevic S, Herrmann R, Pretre V, Ritschard R, Tzankov A, Hess V, Childs A, Hierro C, Rodon J, Hess D, Joerger M, von Moos R, Sessa C, Kristeleit R. First-in human, phase 1, dose-escalation pharmacokinetic and pharmacodynamic study of the oral dual PI3K and mTORC1/2 inhibitor PQR309 in patients with advanced solid tumors (SAKK 67/13). Eur J Cancer. 2018 Jun;96:6-16. doi: 10.1016/j.ejca.2018.03.012. Epub 2018 Apr 13.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Wicki, Dr. study chair
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PQR309 in people with Advanced Solid Tumors, run by PIQUR Therapeutics AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) (time frame: In average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01940133, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.