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CancerPhase 1NCT02483858

Study of Oral PQR309 in Patients With Advanced Solid Tumors

A Phase 1 study testing PQR 309 in people with Cancer, run by PIQUR Therapeutics AG at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, multi-center, non-randomized, dose escalation Phase 1 study evaluating safety, tolerability, PK (pharmacokinetics) and efficacy of PQR309 in the treatment of selected patients with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cancer
What is being tested?
PQR 309
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteUnited States
Study dates
21 Mar 2019to 21 Mar 2019
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

  • Patients ≥ 18 years of age.
  • Histologically or cytologically confirmed diagnosis of solid malignancy, for which no standard curative or life prolonging therapy is available.
  • Have an ECOG Performance Status of ≤ 1. Refer to Appendix 1.
  • Life expectancy of ≥ 12 weeks.
  • Adequate bone marrow, liver, and renal functions, defined as:
  • Platelet count ≥ 100 x 109/L, absolute neutrophil count (ANC)
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  • ≥ 1.5 x 109/L, Hemoglobin ≥ 9 g/dL.
  • ALT and AST ≤ 2.5 upper limit normal (ULN), or < 5 x ULN if liver metastases are present; serum total bilirubin ≤ ULN or 1.5 x ULN if liver metastases are present or total 3 x ULN with direct bilirubin ≤ ULN in patients with well documented Gilbert Syndrome.
  • Serum Creatinine < 1.5 x ULN (upper limit of normal) or estimated creatinine clearance ≥ 60 mL/min, as calculated using method standard for the institution (Appendix 2).
  • Glycated hemoglobin (HgbA1c) ≤ 7 %; Fasting Plasma Glucose (FPG) ≤ 7.0 mmol/L (125 mg/dL).
  • Women of childbearing potential must have a negative pregnancy test (urine or serum) performed within 7 days prior to the start of study drug.
  • Able and willing to swallow and retain oral medication.
  • Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
  • Expansion part:
  • Patients must have known PI3K/mTOR pathway gene aberrations (from molecular profiling studies).
  • Patients must have HPV positive HNSCC containing activating PIK3CA mutations.

Who cannot join

  • Concurrent or previous anti-cancer chemotherapy, immunotherapy or investigational agents < 3 weeks, or palliative radiation < 2 weeks prior to the first day of study treatment. Patients who receive gamma knife radiosurgery for brain metastases or whole brain radiation are eligible if gamma knife radiosurgery was performed > 2 weeks before treatment is started or whole brain radiation was performed > 4 weeks before treatment is started, and are clinically stable.
  • Hormonal anticancer therapies except for LHRH antagonists or LHRH agonists in hormone-refractory prostate cancer
  • Patient has a known hypersensitivity to any of the excipients of PQR309.
  • Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
  • Patients with poorly controlled diabetes mellitus, steroid-induced diabetes mellitus, HbA1c > 7%, or FPG > 7.0 mmol/L (125 mg/dL).
  • Patients who are on (or will require) prolonged systemic corticosteroid treatment during the study, except for:
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  • if receiving corticosteroids, patients must have been on a stable or decreasing dose of corticosteroids and no more than 1 mg of dexamethasone a day or equivalent, i.e. 6 mg prednisone or 25 mg hydrocortisone for at least 5 days prior to date of enrollment.
  • a short duration (< 5 days) of systemic corticosteroids e.g., of chronic obstructive pulmonary disease, or as an antiemetic corresponding at maximum to the anti-inflammatory potency of 4 mg dexamethasone for treatment;
  • topical applications for treatment of e.g., rash, inhaled sprays for treatment of e.g., obstructive airways diseases, eye drops or local Protocol No. PQR309-003 Protocol Amendment 3, 23 September 2015 PIQUR Therapeutics AG - Confidential Page 15 of 108 injections (e.g., intra-articular);
  • Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug, see section 11.1.2.7.
  • Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study (e.g., active or uncontrolled severe infection, chronic active hepatitis, immuno-compromised, acute or chronic pancreatitis, uncontrolled high blood pressure, interstitial lung disease, etc.).
  • Patient has a known history of HIV infection (testing not mandatory).
  • Patient has any of the following cardiac abnormalities:
  • History of, or current, documented congestive heart failure (New York Heart Association functional classification III - IV), documented cardiomyopathy.
  • Left Ventricular Ejection Fraction (LVEF) < 40% as determined by Multiple Gated Acquisition (MUGA) scan or echocardiogram (ECHO).
  • Myocardial infarction ≤ 6 months prior to enrolment.
  • Unstable angina pectoris.
  • Serious uncontrolled cardiac arrhythmia.
  • Symptomatic pericarditis.
  • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
  • 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.
  • Patient has a history of non-compliance to medical regimen or inability to grant consent.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin (hCG) laboratory test (> 5 mIU/mL). Patients with elevated hCG at baseline that is judged to be related to the tumor are eligible if hCG levels do not show the expected doubling when repeated 5 - 7 days later, or pregnancy has been ruled out by vaginal ultrasound.
  • Patient who does not apply highly effective contraception during the study from screening until 90 days after discontinuing study treatment Protocol No. PQR309-003 Protocol Amendment 3, 23 September 2015 PIQUR Therapeutics AG - Confidential Page 16 of 108 (see section 11.3).
  • Patients have any of the following mood disorders as judged by the Investigator or a Psychiatrist, or who meets the cut-off score of ≥ 12 the PHQ-9 or a cut-off of ≥ 15 in the GAD-7 mood scale, respectively, or selects a positive response of '1, 2, or 3' to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9) see Appendix 4.
  • Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others).
  • ≥ CTCAE Grade 3 anxiety.
  • Patients with a history of interstitial

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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

This is an open-label, multi-center, non-randomized, dose escalation Phase 1 study evaluating safety, tolerability, PK (pharmacokinetics) and efficacy of PQR309 in the treatment of selected patients with advanced solid tumors.

Read the detailed description

This is an open-label, multi-center, non-randomized, dose escalation Phase 1 study evaluating safety, tolerability, PK (pharmacokinetics)and efficacy of PQR309 in the treatment of selected patients with advanced solid tumors.

In the initial phase of the study, patients will be treated once daily until disease progression, unacceptable toxicity, patient's request for withdrawal, investigator judgment or death whichever comes first. Enrollment of an initial patient cohort of 3 or 6 patients will follow the traditional 3 + 3 dose escalation scheme to evaluate Dose Levels 1 - 5 with continuous q.d dosing schedule. Patients will be treated with PQR309 at starting Dose Level 1 enrolling exceptionally 6 patients (only applicable for continuous dosing schedule). Subsequent patient cohort(s) will be enrolled depending on the safety and tolerability of the initial cohort. If < 33% patients treated at Dose Level 1 (80 mg) experience Dose Limiting Toxicities (DLT - see definition below) by the end of first treatment cycle (21 days), next cohort of 3 patients will be enrolled and treated at Dose Level 2 of the continuous dosing schedule, if 2 or more treatment-related DLTs are observed at Dose Level 1, patients will be accrued to Dose Level -1. If 2 or more patients experience a DLT during dose Level 2 (120 mg), the dose of 100 mg will be explored next.The MTD is defined as the maximum dose level at which ≤ 1/6 patients have DLTs. After the MTD has been established with the continuous dosing schedule, the study will be expanded to evaluate the MTD of intermittent dosing schedules. Initially 2 additional dosing schedules, intermittent schedule A and B, will be evaluated in parallel. Patients will be assigned to the two schedules in an alternating manner.

Patients will be treated only within dose and schedule cohort they have been enrolled in. No within-patient dose escalation or alteration of dosing schedule will be allowed.Both schedules A and B will evaluate intermittent dosing in 21 day cycles:

Intermittent schedule A:

Two days of once daily PQR309 administration followed by no treatment for 5 days.

Intermittent schedule B:

PQR309 administration on Monday and Thursday. Same dose escalation procedures will apply to intermittent schedule evaluation as for the continuous schedule. Based on the overall evaluation of safety and tolerability, the PK (pharmacokinetics) data of the intermittent dosing schedules and the continuous schedule as well as PQR309 non-clinical data, evaluation of additional dosing schedules may be considered and investigated if agreed between sponsor and study investigators.

After the MTD has been established with the intermittent dosing schedules, the study will be expanded to evaluate the MTD of one selected schedule in patients with:

  • Solid tumors with PI3K/mTOR pathway activation
  • HPV positive HNSCC patients containing activating PIK3CA mutations Evaluation of the data from these cohorts will allow for more complete evaluation of tolerability, pharmacokinetics, and correlative endpoints as well as the preliminary clinical efficacy of PQR309.
Conditions
Cancer
Being tested
PQR 309
Keywords
oncology, solid tumors
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PQR 309Drug

    Also called PI3K/mTOR/AKT Inhibitor

    Intervention of this drug may include safety, tolerability, PK (pharmacokinetics) and efficacy

Study groups in NCT02483858
Study groupRoleWhat they receive
PQR309ExperimentalDifferent dose Evaluation (continous and intermittent) 20-160mg daily
Receives: Drug: PQR 309

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To identify the Maximum Tolerated Dose (MTD) of PQR309 administered in different (continuous and intermittent) dosing schedules. To evaluate efficacy of PQR309 in selected patient population: • Solid tumors with PI3K/mTOR activation • Human Papilloma

    MTD based on the rate of dose-limiting toxicities. The MTD is defined as the maximum dose level at which ≤ 1/6 patients have dose limiting toxicities (DLTs).

    Measured: In average 1 year

  2. Objective response rate (ORR) according to the response evaluation• Solid tumors with PI3K/mTOR activation • Human Papilloma Virus (HPV) positive Head and neck squamous cell carcinoma (HNSCC) containing activating PIK3CA mutations

    Expansion part criteria in solid tumors (RECIST), version 1.1

    Measured: in average 2 years

Secondary outcomes (60)

  1. Number of patients with adverse Events and serious adverse events

    Continous Dosing and intermittent dosing "2days on/5days off

    Measured: Cycle1 on Day1,8,15, Cycle 2 and subsequent cycles on Day 1, End of the treatment up to 3 days and as follow up 30 days after last dosing

  2. Number of patients with adverse Events and serious adverse events

    "Monday/ Thursday"

    Measured: Assessment on Day 1 after basline, Cycle1 on Day 8,15, Cycle 2 and subsequent cycles on Day 1, End of the treatment up to 3 days and as follow up 30 days after last dosing

  3. Physical examination according to ECOG (Eastern Cooperative Oncology Group) Performance Status

    Continous Dosing

    Measured: Cycle 1 on Day 8,15, Cycle 2 and subsequent cycles on Day1 , end of treatment up to 3 days after

  4. Physical examination according to ECOG (Eastern Cooperative Oncology Group) Performance Status

    Intermittent Dosing "2days on/5days off"

    Measured: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1 , end of treatment up to 3 days after

  5. Physical examination according to ECOG (Eastern Cooperative Oncology Group) Performance Status

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day1,2, Cycle 1 on Day 4,8,9,15

  6. Change in Pulse Rate

    Continous Dosing

    Measured: Assessment on Day 3 after baseline, Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  7. Change in Pulse Rate

    Intermittent Dosing "2 days on/5days off"

    Measured: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  8. Change in Pulse Rate

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15

  9. Change in Temperature

    Continous Dosing

    Measured: Assessment on Day 3 after baseline, Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  10. Change in Temperature

    Intermittent Dosing "2days on/5days off"

    Measured: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  11. Change in Temperature

    Intermittent Dosing " Assessment on Day1,2,Cycle 1 on Day 4,8,9,15

    Measured: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15

  12. Change in Respiratory Rate

    Continous Dosing

    Measured: Assessment on Day 3 after baseline, Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  13. Change in Respiratory Rate

    Intermittent Dosing "2days on/5days off"

    Measured: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  14. Change in Respiratory Rate

    Intermittent Dosing " Monday/ Thursday"

    Measured: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15

  15. Change in Blood Pressure

    Continous Dosing

    Measured: Assessment on Day 3 after baseline, Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  16. Change in Blood Pressure

    Intermittent Dosing "2days on/5days off"

    Measured: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  17. Change in Blood Pressure

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15

  18. Change in Blood Body Weight

    Continous Dosing

    Measured: Assessment on Day 3 after baseline, Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  19. Change in Blood Body Weight

    Intermittent Dosing "2days on/5days off"

    Measured: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  20. Change in Blood Body Weight

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15

  21. Change in ECG

    Continous Dosing

    Measured: Assessment on Day 3 after baseline, Cycle 1 on Day 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  22. Change in ECG

    Intermittent Dosing "2days on/5days off" and "Monday/ Thursday"

    Measured: After Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  23. Depression test (PHQ-9)

    Continous Dosing

    Measured: After Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  24. Depression test (PHQ-9)

    Intermittent Dosing "2days on/5days off" and "Monday/ Thursday"

    Measured: Cycle 1 on Day 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  25. Generalized anxiety disorder mood scale score (GAD7)

    Continous Dosing and Intermittent Dosing "2days on/5days off" and "Monday/ Thursday"

    Measured: Cycle 1 on Day 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  26. Changes in routine blood chemistry

    Continous Dosing and Intermittent Dosing "2days on/5days off"

    Measured: Cycle 1 on Day 1, 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  27. Changes in routine blood chemistry

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1 after baseline, Cycle 1 on Day 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  28. Changes of hematology

    Continous Dosing and Intermittent Dosing "2days on/5days off"

    Measured: Cycle 1 on Day 1, 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  29. Changes of hematology

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1 after baseline, Cycle 1 on Day 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  30. Changes of insulin/Glucose/ C-peptide

    Continous Dosing

    Measured: Assessment on Day 3, ,2,1 after baseline, Cycle 1 on Day 1, Cycle 2 and subsequent cycles on Day1

  31. Changes of insulin/Glucose/ C-peptide

    " Intermittent Dosing "2days on/5days off""

    Measured: Assessment on Day 3, 2,1 after baseline, Cycle 8,9,15 on Day 1

  32. Changes of insulin/Glucose/ C-peptide

    " Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1,2 after baseline, Cycle1 on Day 4, 8,9,15

  33. Changes of haemostasis

    Continous Dosing and Intermittent Dosing "2days on/5days off"

    Measured: Cycle 1 on Day 1, 8, 15 Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  34. Changes of haemostasis

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1 after baseline, Cycle 1 on Day 1,15 Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication

  35. Determination of Cmax

    Continous Dosing

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1

  36. Determination of Cmax

    Intermittent Dosing "2days on/5days off"

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15

  37. Determination of Cmax

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15

  38. Determination of AUC 0-24

    Continous Dosing

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1

  39. Determination of AUC 0-24

    Intermittent Dosing "2days on/5days off"

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15

  40. Determination of AUC 0-24

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15

  41. Determination of tmax

    Continous Dosing

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1

  42. Determination of tmax

    Intermittent Dosing "2days on/5days off"

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15

  43. Determination of tmax

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15

  44. Determination of AUClast (area under the curve)

    Continous Dosing

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1

  45. Determination of AUClast

    Intermittent Dosing "2days on/5days off"

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15

  46. Determination of AUClast

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15

  47. Determination of AUC0-∞

    Continous Dosing

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1

  48. Determination of AUC0-∞

    Intermittent Dosing "2days on/5days off"

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15

  49. Determination of AUC0-∞

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15

  50. Determination of t 1/2

    Continous Dosing

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1

  51. Determination of t 1/2

    Intermittent Dosing "2days on/5days off"

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15

  52. Determination of t 1/2

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15

  53. Determination of RAC (Accumulation Ratio)

    Continous Dosing

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1

  54. Determination of RAC (Accumulation Ratio)

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15

  55. Determination of RAC (Accumulation Ratio)

    Intermittent Dosing "Monday/ Thursday"

    Measured: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15

  56. Determine Time to Response (TTR)

    Efficacy

    Measured: up to 2 years

  57. Determine Duration of Response (DOR)

    Defined as the time from the date of the first confirmed response to the first documentation of relapse or progressive disease, whichever occurs first

    Measured: baseline and on Day 1 of every subsequential cycle which can be up to 24 months

  58. Time to Treatment Failure (TTF)

    Defined as the time from study entry to any treatment failure including disease progression or discontinuation of treatment for any reason (e.g., disease progression, AE, patient preference, initiation of new treatment without documented progression, death)

    Measured: Tumor Measurement preferably with a ruler and/or MRI scans e.g. and incorporated clinical signs will be assesses at baseline and on Day 1 of every subsequential cycle which can be up to 24 months

  59. Determine Progression Free Survival (PFS)

    Defined as the time from study entry to progression or death due to any cause

    Measured: baseline and on Day 1 of every subsequential cycle which can be up to 24 months

  60. 1- year Survival Rate

    Defined as the time from study entry to death as a result of any cause at 1-year cutoff date

    Measured: baseline and on Day 1 of every subsequential cycle which can be up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jun 2015 (estimated)
  2. Study start21 Mar 2019
  3. Primary completion21 Mar 2019
  4. Study completion21 Mar 2019

Resources

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
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02483858
Sponsor's protocol ID
PQR309-003
Status last verified
Mar 2019
First submitted
19 May 2015
Last updated
22 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PQR 309 in people with Cancer, run by PIQUR Therapeutics AG at 1 site in United States.

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 16 inclusion and 28 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 22 Mar 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 United States. 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?

To identify the Maximum Tolerated Dose (MTD) of PQR309 administered in different (continuous and intermittent) dosing schedules. To evaluate efficacy of PQR309 in selected patient population: • Solid tumors with PI3K/mTOR activation • Human Papilloma (time frame: In average 1 year). The study lists 2 primary outcomes in all. 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 NCT02483858.

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 22 Mar 2019.

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