LymphomaPhase 2NCT03127020
Phase 2 Study With PQR309 in Relapsed or Refractory Lymphoma Patients
A Phase 2 study testing PQR309 in people with Lymphoma and Non-Hodgkin Lymphoma, run by PIQUR Therapeutics AG at 1 site in Germany.
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 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, Non-Hodgkin Lymphoma
- What is being tested?
- PQR309
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2016to 21 Mar 2019
- 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 regardless of transformation status. 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
Show all 18Show fewer
- 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
- Adequate renal function, defined as serum creatinine ≤ 1.5 times ULN
- Fasting glucose < 7.0 mmol/L
- 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 consent1.5 cm in longest transverse diameter.
- 3. Age >18 years 4. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-1 5. Adequate organ system functions defined as:
- Absolute neutrophil count (ANC) >1.0x109/l
- Platelets > 75x109/l
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
- 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 and steroids (steroids as maintenance for adrenal insufficiency are allowed)).
Show all 20Show fewer
- 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 (section 11.1.3.7).
- 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 4 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 (e.g. chronic active hepatitis) 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 levels in inclusion criteria).
Trial locations and contacts
1 site in 1 country.
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 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 PQR309 in patients with relapsed or refractory lymphoma.
The maximum tolerated dose (MTD) of PQR309 in patients with advanced solid tumours was defined as 80 mg once daily given continuously (q.d. schedule) in a previous phase 1 study [8]. The safety run-in of this study will follow a modified 3 + 3 design to evaluate the safety of 60 and 80 mg PQR309 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 PQR309 for 28 days. Enrollment and treatment of all three patients may occur simultaneously as 80 mg PQR309 p.o. qd was established as the MTD maximum tolerated dose in solid tumours. Unless a DLT (dose-limiting toxicity) 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 PQR309, data emerge during the step 1 of the phase 2 expansion in this PQR309 002A study, indicating that daily dosing of PQR309 is not adequately tolerated or inefficacious.
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 PQR309, data emerge during the step 1 of the phase 2 expansion in this PQR309 002A study, indicating that daily dosing of PQR309 is not adequately tolerated or inefficacious.
- Conditions
- Lymphoma, Non-Hodgkin Lymphoma
- Being tested
- PQR309
- 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.
PQR309Drug
Also called PI3K Inhibitor (phosphatidylinositol 3-kinase)
taken continuously on daily basis (60mg, 80mg) or intermittent dosing (120mg, 140mg, 160mg)
| Study group | Role | What they receive |
|---|---|---|
| PQR309 | Experimental | PQR309 being taken continuously on daily basis (60,80mg) or intermittent (120mg, 140mg, 160mg) dosing Receives: Drug: PQR309 |
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 days prior to first treatment (baseline), during study treatment every 8 weeks during first 6 months and every 6 months afterwards up to 48 months
Secondary outcomes (19)
Incidence of serious adverse events (SAEs), incidence and severity of all adverse events (AEs)
Continuous and intermittent dosing
Measured: During treatment on Day 1, 2, 8, 15, 22, 36 and 50; at the endof treatment and 30 days after last dose.
Change in pulse rate
Continuous and intermittent dosing
Measured: Before treatment on Day 1,2 and after treatment started on Day 1,2, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in blood pressure
Continuous and intermittent dosing
Measured: Before treatment on Day 1,2 and after treatment started on Day 1,2, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in body temperature
Continuous and intermittent dosing
Measured: Before treatment on Day 1,2 and after treatment started on Day 1, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in ECOG (Eastern Cooperative Oncology Group) Performance Status
Continuous and intermittent dosing
Measured: Before treatment on Day 1,2 and after treatment started on Day 1,8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in bodyweight/kg
Continuous and intermittent dosing
Measured: Before treatment on Day 1,2 and after treatment started on Day 1,2, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in haematology
Continuous and intermittent dosing
Measured: Before treatment on Day 1,2 and after treatment started on Day 1, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in blood chemistry
Continuous and intermittent dosing
Measured: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in haemostasis
Continuous and intermittent dosing
Measured: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in ECG (electrocardiogram)
Continuous and intermittent dosing
Measured: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in urine analysis
Continuous and intermittent dosing
Measured: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in HbA1c
Continuous and intermittent dosing
Measured: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in Cmax
Continuous and intermittent dosing
Measured: During treatment on Day1, 2,8, 15,22 and 50
Change in tmax
Continuous and intermittent dosing
Measured: During treatment on Day1, 2, 8, 15,22 and 50
Change in AUC0-24 •
Continuous and intermittent dosing
Measured: During treatment on Day1, 2, 8, 15,22 and 50
Change in AUClast,
Continuous and intermittent dosing
Measured: During treatment on Day1, 2, 8, 15,22 and 50
Change in AUC0-∞,
Continuous and intermittent dosing
Measured: During treatment on Day1, 2, 8, 15,22 and 50
Change in t1/2 •
Continuous and intermittent dosing
Measured: During treatment on Day1, 2, 8, 15,22 and 50
Change in RAC •
Continuous and intermittent dosing
Measured: During treatment on Day1, 2, 8, 15,22 and 50
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study startJun 2016
- Primary completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies 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
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- PIQUR Therapeutics AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospital, Basel, Switzerland, University Hospital Munich, University Hospital Freiburg, Charite University, Berlin, Germany, University of Stuttgart
- Responsible party
- Sponsor
- Investigators
- Martin Dreyling, Study director, Klinik Universität München
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127020
- Sponsor's protocol ID
- PQR309-002A
- Status last verified
- Jun 2019
- First submitted
- 14 Apr 2016
- Last updated
- 28 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 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
- NCT03127020
- Acronym / sponsor ID
- PQR309-002A
- Conditions
- Lymphoma, Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- PIQUR Therapeutics AGIndustry (pharma, biotech, devices)
- Collaborators
- University Hospital, Basel, Switzerland, University Hospital Munich, University Hospital Freiburg, Charite University, Berlin, Germany, University of Stuttgart
- Study start
- Jun 2016 (actual)
- Primary completion
- 21 Mar 2019 (actual)
- First posted
- 25 Apr 2017 (actual)
- 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 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 PQR309 in patients with relapsed or refractory lymphoma.
The maximum tolerated dose (MTD) of PQR309 in patients with advanced solid tumours was defined as 80 mg once daily given continuously (q.d. schedule) in a previous phase 1 study [8]. The safety run-in of this study will follow a modified 3 + 3 design to evaluate the safety of 60 and 80 mg PQR309 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 PQR309 for 28 days. Enrollment and treatment of all three patients may occur simultaneously as 80 mg PQR309 p.o. qd was established as the MTD maximum tolerated dose in solid tumours. Unless a DLT (dose-limiting toxicity) 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 PQR309, data emerge during the step 1 of the phase 2 expansion in this PQR309 002A study, indicating that daily dosing of PQR309 is not adequately tolerated or inefficacious.
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 PQR309, data emerge during the step 1 of the phase 2 expansion in this PQR309 002A study, indicating that daily dosing of PQR309 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 |
|---|---|---|
| PQR309 | Experimental | Drug: PQR309PQR309 being taken continuously on daily basis (60,80mg) or intermittent (120mg, 140mg, 160mg) dosing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Histologically confirmed diagnosis* of relapsed or refractory lymphoma, received at least two prior lines of therapy regardless of transformation status. 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 (20 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 and steroids (steroids as maintenance for adrenal insufficiency are allowed)).
- 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 (section 11.1.3.7).
- 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 |
|---|---|---|
| PQR309Also: PI3K Inhibitor (phosphatidylinositol 3-kinase)taken continuously on daily basis (60mg, 80mg) or intermittent dosing (120mg, 140mg, 160mg) | Drug | 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 days prior to first treatment (baseline), during study treatment every 8 weeks during first 6 months and every 6 months afterwards up to 48 months
Radiological lymphoma Evaluation (CT or other indicated according to institutional Standard practice), clinical examination and bone marrow biopsy
19 secondary outcomes
Incidence of serious adverse events (SAEs), incidence and severity of all adverse events (AEs)
Time frame: During treatment on Day 1, 2, 8, 15, 22, 36 and 50; at the endof treatment and 30 days after last dose.
Change in pulse rate
Time frame: Before treatment on Day 1,2 and after treatment started on Day 1,2, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in blood pressure
Time frame: Before treatment on Day 1,2 and after treatment started on Day 1,2, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in body temperature
Time frame: Before treatment on Day 1,2 and after treatment started on Day 1, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in ECOG (Eastern Cooperative Oncology Group) Performance Status
Time frame: Before treatment on Day 1,2 and after treatment started on Day 1,8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in bodyweight/kg
Time frame: Before treatment on Day 1,2 and after treatment started on Day 1,2, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in haematology
Time frame: Before treatment on Day 1,2 and after treatment started on Day 1, 8, 15, 22, 36, 50 and subsequently every 4 weeks , at the end of treatment and 30 days after last treatment
Change in blood chemistry
Time frame: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in haemostasis
Time frame: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in ECG (electrocardiogram)
Time frame: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in urine analysis
Time frame: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in HbA1c
Time frame: Before treatment on Day 1and after treatment started on Day 1, 22, 50 and subsequently every 4 weeks and at the end of treatment
Change in Cmax
Time frame: During treatment on Day1, 2,8, 15,22 and 50
Change in tmax
Time frame: During treatment on Day1, 2, 8, 15,22 and 50
Change in AUC0-24 •
Time frame: During treatment on Day1, 2, 8, 15,22 and 50
Change in AUClast,
Time frame: During treatment on Day1, 2, 8, 15,22 and 50
Change in AUC0-∞,
Time frame: During treatment on Day1, 2, 8, 15,22 and 50
Change in t1/2 •
Time frame: During treatment on Day1, 2, 8, 15,22 and 50
Change in RAC •
Time frame: During treatment on Day1, 2, 8, 15,22 and 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 28 Jun 2019.
- Individual participant dataSharing planned: No
Related trials for Lymphoma
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
Active, not recruitingPhase 1/2
Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma
Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma
Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
RecruitingPhase 1
225Ac-DOTA-Anti-CD38 Daratumumab Monoclonal Antibody With Fludarabine, Melphalan and Total Marrow and Lymphoid Irradiation as Conditioning Treatment for Donor Stem Cell Transplant in Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia and Myelodysplastic Syndrome
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
Recruiting
More Than Just X-Rays - Imaging of Chemotherapy-induced Morphological and Functional Cardiovascular and Lung Changes After Childhood ALL and Other Cancers - a Monocentric Late Effects Study (MaximALL)
Acute Lymphatic Leukemia, Lymphoma
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.
Martin Dreyling study director
Klinik Universität München
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PQR309 in people with Lymphoma and Non-Hodgkin Lymphoma, run by PIQUR Therapeutics AG at 1 site in Germany.
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 18 inclusion and 20 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 28 Jun 2019. 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 Germany. 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 days prior to first treatment (baseline), during study treatment every 8 weeks during first 6 months and every 6 months afterwards up to 48 months). 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 28 Jun 2019.