Lymphoma, MalignantPhase 2NCT02249429
Open-Label, Non Randomized Phase 2 Study With Safety Run-In
A Phase 2 study testing bimiralisib in people with Lymphoma, Malignant, run by PIQUR Therapeutics AG at 12 sites in 6 countries.
Trial summary
The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of bimiralisib (PQR309) administered orally, as once daily capsules continuously and on intermittent schedule in patients with relapsed or refractory lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Malignant
- What is being tested?
- bimiralisib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 12 sitesin 6 countries
- Study dates
- May 2015to 11 Sep 2018
- Phase
- Phase 2
- 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 confirmed diagnosis* of relapsed or refractory lymphoma, received at least two prior lines of therapy including immuno-chemotherapy. Patients with relapsed Chronic Lymphoid Leukemia (CLL) are eligible if they have received one or more prior lines of any approved standard therapy. * archival biopsies may be used if obtained up to a year prior to enrollment; re-biopsy is strongly recommended if last biopsy was obtained more than a year ago.
- Only for patients in the Phase 2 part: At least one measurable nodal or extra-nodal lesion defined as follows: Clearly measurable (i.e. well-defined boundaries) in at least two perpendicular dimensions on imaging scan with > 1.5 cm in longest transverse diameter.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1 (See Appendix 2).
- Adequate organ system functions defined as:
- Absolute neutrophil count (ANC) ≥1.0x109/l
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- Platelets ≥ 75x109/l
- Haemoglobin ≥ 85g/L
- Adequate hepatic function, defined as Total bilirubin ≤ 1.5 times the upper limit of normal (ULN) and Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN (or ALT/AST ≤ 5 times ULN in patients with liver involvement)
- Adequate renal function, defined as serum creatinine ≤ 1.5 times ULN
- Fasting glucose < 7.0 mmol/L; Glycated haemoglobin (HbA1c) < 6.4%
- Ability and willingness to swallow and retain oral medication.
- Willingness and ability to comply with the trial procedures
- Female and male patients with reproductive potential must agree to use effective contraception from screening until 90 days after discontinuation of PQR309
- Signed informed consent
Who cannot join
- Any of the following conditions precludes enrollment of a patient:
- Immunosuppression due to:
- Allogeneic hematopoietic stem cell transplant (HSCT)
- Any immune-suppressive therapy within 4 weeks prior to trial treatment start
- Known HIV infection
- Autologous stem cell transplant within 3 months prior to trial treatment start.
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- Concomitant anticancer therapy (e.g. chemotherapy, radiotherapy, hormonal therapy, immunotherapy, biological response modifier, signal transduction inhibitors).
- Concomitant treatment with medicinal products that increase the pH (reduce acidity) of the upper gastrointestinal tract, including, but not limited to, proton-pump inhibitors (e.g. omeprazole), H2-antagonists (e.g. ranitidine) and antacids. Patients may be enrolled in the study after a wash-out period sufficient to terminate their effect.
- Use of any investigational drug within 21 days prior to trial treatment start.
- Patients who experienced National Cancer Institute (NCI) Common Terminology Criteria For Adverse Events (CTCAE) ≥ Grade 3 on PI3K/mTOR inhibitors
- Any major surgery, chemotherapy or immunotherapy within 21 days prior to trial treatment start.
- Symptomatic or progressing Central nervous system (CNS) involvement. Exception: Patients with meningeal involvement can be included upon discussion between the sponsor and the investigator.
- Persisting toxicities NCI CTCAE ≥2 related to prior anticancer therapy
- Presence of gastrointestinal disease or any other condition that could interfere significantly with the absorption of the study drug.
- Severe/unstable angina, myocardial infarction or coronary artery bypass within the last 3 years prior to trial treatment start, symptomatic congestive heart failure New York Heart Association (NYHA) Class 3 or 4, hypertension BP>150/100mmHg
- A serious active infection at the time of treatment, or another serious underlying medical condition that could impair the ability of the patient to receive treatment.
- Lack of appropriate contraceptive measures (male and female)
- Pregnant or lactating women
- Known HIV infection
- Significant medical conditions which could jeopardize compliance with the protocol.
- Uncontrolled diabetes mellitus; patients with controlled diabetes may be enrolled (see fasting glucose and HbA1c levels in inclusion criteria).
Trial locations and contacts
12 sites in 6 countries.
12 sites in 6 countries
United Kingdom4 sites
Guy's Hospital
London, SE1 9RT
Royal Marsden NHS Foundation Trust
London
University College Hospital London
London
Churchill Hospital
Oxford, OX3 7DQ
Serbia3 sites
Institute for Oncology and radiology of Serbia
Belgrade, 110000
Clinical Center Kragujevac
Kragujevac, 34000
Clinical Center Nis
Niš, 118000
Bosnia and Herzegovina2 sites
University Clinical Center Republic of Srpska
Banja Luka, 78000
University Clinical Center Sarajevo
Sarajevo, 71000
About this study
Official title: Open-Label, Non Randomized Phase 2 Study With Safety Run-In Evaluating Efficacy and Safety of PQR309 in Patients With Relapsed or Refractory Lymphoma
The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of bimiralisib (PQR309) administered orally, as once daily capsules continuously and on intermittent schedule in patients with relapsed or refractory lymphomas.
Read the detailed description
Open-label, non-randomized, multicentre phase 2 study with a safety run-in evaluating efficacy and safety of bimiralisib (PQR309) in patients with relapsed or refractory lymphoma.
The maximum tolerated dose (MTD) of bimiralisib in patients with advanced solid tumors was defined as 80 mg once daily given continuously (q.d. schedule) in a previous phase 1 study. The safety run-in of this study will follow a modified 3 + 3 design to evaluate the safety of 60 and 80 mg bimiralisib in patients with relapsed or refractory lymphoma administered p.o. once daily during a DLT (dose-limiting toxicity) period of 28 days.
In the safety run-in, three patients will be treated at 60 mg bimiralisib for 28 days. Enrollment and treatment of all three patients may occur simultaneously as 80 mg bimiralisib p.o. qd was established as the MTD in solid tumors. Unless a DLT is observed in any of the three patients during the first 28 days of treatment, the investigators and the sponsor will decide to escalate the dose to 80 mg. Intermittent dosing schedules may be evaluated if, based on the overall evaluation of all the clinical and PK (pharmacokinetic) data from this and other studies with bimiralisib, data emerge during step 1 of the phase 2 expansion in this study, indicating that daily dosing of bimiralisib is not adequately tolerated or inefficacious.
- Conditions
- Lymphoma, Malignant
- Being tested
- bimiralisib
- Keywords
- Non Hodgkin Lymphoma
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bimiralisibDrug
Also called PQR309, PI3K Inhibitor (phosphatidylinositol 3-kinase)
60 mg or 80 mg bimiralisib per oral (p.o.) once daily or intermittent dosing (120mg,140mg and 160mg) until unacceptable AE, disease progression, patient's request for withdrawal, investigator judgement or death - whichever comes first.
| Study group | Role | What they receive |
|---|---|---|
| bimiralisib (PQR309) | Experimental | Not described Receives: Drug: bimiralisib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Change of Tumor Response Criteria in lymphoma patients During Treatment with PQR309 in patients with relapsed or refractory lymphoma according to Cheston Criteria (5)
Radiological lymphoma Evaluation (CT or other indicated according to institutional standard practice), clinical examination and bone marrow biopsy
Measured: 28 day prior to first treatment (baseline), during treatment every 8 weeks during 6 months and every 6 months afterwards up to 1 year)
Secondary outcomes (18)
Incidence of serious adverse events (SAE) and severity of all adverse events (AEs)
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, at the end of treatment up to 1 year and 30 days after last dose
Change of pulse rate
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, at the end of treatment up to 1 year and 30 days after last dose
Change in blood pressure
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in body temperature
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in ECOG (Eastern Cooperative Oncology Group) Performance status
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in body weight
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in haematology
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in blood chemistry
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1 and during treatment on Day 1,22,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year
Change in ECG (electrocardiogram)
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1 and during treatment on Day 1,22,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year
Change of urine analysis
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1 and during treatment on Day 1,22,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year
Change in HbA1c
Continuous dosing and intermittent dosing
Measured: Before treatment on Day -1 and during treatment on Day 1,22,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year
Change in tmax
Continuous dosing and intermittent dosing
Measured: During treatment on Day 1,2, 8,15 22, 50
Change in Cmax
Continuous dosing and intermittent dosing
Measured: During treatment on Day 1,2, 8,15 22, 50
Change in AUC 0-24
Continuous dosing and intermittent dosing
Measured: During treatment on Day 1,2, 8,15 22, 50
Change in AUClast
Continuous dosing and intermittent dosing
Measured: During treatment on Day 1,2, 8,15 22, 50
Change in AUC0-∞,
Continuous dosing and intermittent dosing
Measured: During treatment on Day 1,2, 8,15 22, 50
Change in t1/2
Continuous dosing and intermittent dosing
Measured: During treatment on Day 1,2, 8,15 22, 50
Change in RAC
Continuous dosing and intermittent dosing
Measured: During treatment on Day 1,2, 8,15 22, 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2014 (estimated)
- Study startMay 2015
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, MalignantStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- PIQUR Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals, Churchill Hospital, Royal Marsden NHS Foundation Trust, University of Haifa, Weill Medical College of Cornell University, Institut Curie, University Clinical Center, Sarajevo, Clinical Center Kragujevac, Clinical Center Nis, Nis, Institute for Oncology and Radiology Serbia, Belgrade, University Clinical Centre of Republic of Srpska
- Responsible party
- Sponsor
- Investigators
- Rakesh Popat, Principal investigator, Univeristy College LondonDavid Cunningham, Principal investigator, Royal Marsden NHS Foundation TrustPaul Fields, Principal investigator, Guy's HospitalGraham Collins, Principal investigator, Churchill HospitalNetanel Horowitz, Principal investigator, University of HaifaGiulino Roth, Principal investigator, Weill Cornell Medicine New YorkCarole Soussain, Principal investigator, Curie InstituteSinisa Radulovic, Principal investigator, Institute for Oncology and Radiology Serbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02249429
- Sponsor's protocol ID
- PQR309-002
- Status last verified
- Aug 2019
- First submitted
- 8 Sep 2014
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Non Randomized Phase 2 Study With Safety Run-In Evaluating Efficacy and Safety of PQR309 in Patients With Relapsed or Refractory Lymphoma
- ClinicalTrials.gov ID
- NCT02249429
- Acronym / sponsor ID
- PQR309-002
- Conditions
- Lymphoma, Malignant
- Keywords
- Non Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- PIQUR Therapeutics AGIndustry (pharma, biotech, devices)
- Collaborators
- University College London Hospitals, Churchill Hospital, Royal Marsden NHS Foundation Trust, University of Haifa, Weill Medical College of Cornell University, Institut Curie, University Clinical Center, Sarajevo, Clinical Center Kragujevac, Clinical Center Nis, Nis, Institute for Oncology and Radiology Serbia, Belgrade, University Clinical Centre of Republic of Srpska
- Study start
- May 2015 (actual)
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 25 Sep 2014 (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.
The main goal of this study is to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D) as well as preliminary antitumor activity of bimiralisib (PQR309) administered orally, as once daily capsules continuously and on intermittent schedule in patients with relapsed or refractory lymphomas.
Detailed description
Open-label, non-randomized, multicentre phase 2 study with a safety run-in evaluating efficacy and safety of bimiralisib (PQR309) in patients with relapsed or refractory lymphoma.
The maximum tolerated dose (MTD) of bimiralisib in patients with advanced solid tumors was defined as 80 mg once daily given continuously (q.d. schedule) in a previous phase 1 study. The safety run-in of this study will follow a modified 3 + 3 design to evaluate the safety of 60 and 80 mg bimiralisib in patients with relapsed or refractory lymphoma administered p.o. once daily during a DLT (dose-limiting toxicity) period of 28 days.
In the safety run-in, three patients will be treated at 60 mg bimiralisib for 28 days. Enrollment and treatment of all three patients may occur simultaneously as 80 mg bimiralisib p.o. qd was established as the MTD in solid tumors. Unless a DLT is observed in any of the three patients during the first 28 days of treatment, the investigators and the sponsor will decide to escalate the dose to 80 mg. Intermittent dosing schedules may be evaluated if, based on the overall evaluation of all the clinical and PK (pharmacokinetic) data from this and other studies with bimiralisib, data emerge during step 1 of the phase 2 expansion in this study, indicating that daily dosing of bimiralisib is not adequately tolerated or inefficacious.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bimiralisib (PQR309) | Experimental | Drug: bimiralisib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed diagnosis* of relapsed or refractory lymphoma, received at least two prior lines of therapy including immuno-chemotherapy. Patients with relapsed Chronic Lymphoid Leukemia (CLL) are eligible if they have received one or more prior lines of any approved standard therapy. * archival biopsies may be used if obtained up to a year prior to enrollment; re-biopsy is strongly recommended if last biopsy was obtained more than a year ago.
- Only for patients in the Phase 2 part: At least one measurable nodal or extra-nodal lesion defined as follows: Clearly measurable (i.e. well-defined boundaries) in at least two perpendicular dimensions on imaging scan with > 1.5 cm in longest transverse diameter.
- Age ≥ 18 years
- Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1 (See Appendix 2).
- Adequate organ system functions defined as:
Key exclusion criteria (21 listed)
- Immunosuppression due to:
- Autologous stem cell transplant within 3 months prior to trial treatment start.
- Concomitant anticancer therapy (e.g. chemotherapy, radiotherapy, hormonal therapy, immunotherapy, biological response modifier, signal transduction inhibitors).
- Concomitant treatment with medicinal products that increase the pH (reduce acidity) of the upper gastrointestinal tract, including, but not limited to, proton-pump inhibitors (e.g. omeprazole), H2-antagonists (e.g. ranitidine) and antacids. Patients may be enrolled in the study after a wash-out period sufficient to terminate their effect.
- Use of any investigational drug within 21 days prior to trial treatment start.
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 |
|---|---|---|
| bimiralisibAlso: PQR309, PI3K Inhibitor (phosphatidylinositol 3-kinase)60 mg or 80 mg bimiralisib per oral (p.o.) once daily or intermittent dosing (120mg,140mg and 160mg) until unacceptable AE, disease progression, patient's request for withdrawal, investigator judgement or death - whichever comes first. | Drug | bimiralisib (PQR309) |
Primary outcome
Assessment of Change of Tumor Response Criteria in lymphoma patients During Treatment with PQR309 in patients with relapsed or refractory lymphoma according to Cheston Criteria (5)
Time frame: 28 day prior to first treatment (baseline), during treatment every 8 weeks during 6 months and every 6 months afterwards up to 1 year)
Radiological lymphoma Evaluation (CT or other indicated according to institutional standard practice), clinical examination and bone marrow biopsy
18 secondary outcomes
Incidence of serious adverse events (SAE) and severity of all adverse events (AEs)
Time frame: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, at the end of treatment up to 1 year and 30 days after last dose
Change of pulse rate
Time frame: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, at the end of treatment up to 1 year and 30 days after last dose
Change in blood pressure
Time frame: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in body temperature
Time frame: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in ECOG (Eastern Cooperative Oncology Group) Performance status
Time frame: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in body weight
Time frame: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in haematology
Time frame: Before treatment on Day -1,-2 and during treatment on Day 1,2,8,15,22,36,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year and 30 days after last dose
Change in blood chemistry
Time frame: Before treatment on Day -1 and during treatment on Day 1,22,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year
Change in ECG (electrocardiogram)
Time frame: Before treatment on Day -1 and during treatment on Day 1,22,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year
Change of urine analysis
Time frame: Before treatment on Day -1 and during treatment on Day 1,22,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year
Change in HbA1c
Time frame: Before treatment on Day -1 and during treatment on Day 1,22,50, subsequently every 4 weeks up to 1 year, at the end of treatment up to 1 year
Change in tmax
Time frame: During treatment on Day 1,2, 8,15 22, 50
Change in Cmax
Time frame: During treatment on Day 1,2, 8,15 22, 50
Change in AUC 0-24
Time frame: During treatment on Day 1,2, 8,15 22, 50
Change in AUClast
Time frame: During treatment on Day 1,2, 8,15 22, 50
Change in AUC0-∞,
Time frame: During treatment on Day 1,2, 8,15 22, 50
Change in t1/2
Time frame: During treatment on Day 1,2, 8,15 22, 50
Change in RAC
Time frame: During treatment on Day 1,2, 8,15 22, 50
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 6 Sep 2019.
- Individual participant dataSharing planned: No
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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.
Rakesh Popat principal investigator
Univeristy College London
David Cunningham principal investigator
Royal Marsden NHS Foundation Trust
Paul Fields principal investigator
Guy's Hospital
12 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing bimiralisib in people with Lymphoma, Malignant, run by PIQUR Therapeutics AG at 12 sites in 6 countries.
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 15 inclusion and 21 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 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United Kingdom, Serbia, Bosnia and Herzegovina, United States, France and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Assessment of Change of Tumor Response Criteria in lymphoma patients During Treatment with PQR309 in patients with relapsed or refractory lymphoma according to Cheston Criteria (5) (time frame: 28 day prior to first treatment (baseline), during treatment every 8 weeks during 6 months and every 6 months afterwards up to 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Sep 2019.