ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of Oral PQR309 in Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02483858
Recruitment Status : Completed
First Posted : June 29, 2015
Last Update Posted : May 9, 2018
Sponsor:
Collaborators:
Roswell Park Cancer Institute
M.D. Anderson Cancer Center
Mayo Clinic
Hospital Clinic of Barcelona
University College London Hospitals
Churchill Hospital
Case Western Reserve University
University Hospital, Zürich
Information provided by (Responsible Party):
PIQUR Therapeutics AG

Brief 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.

Condition or disease Intervention/treatment Phase
Cancer Drug: PQR 309 Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Study of Oral PQR309 in Patients With Advanced Solid Tumors
Study Start Date : January 2015
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: PQR309
Different dose Evaluation (continous and intermittent) 20-160mg daily
Drug: PQR 309
Intervention of this drug may include safety, tolerability, PK (pharmacokinetics) and efficacy
Other Name: PI3K/mTOR/AKT Inhibitor




Primary Outcome Measures :
  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 [ Time Frame: In average 1 year ]
    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).

  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 [ Time Frame: in average 2 years ]
    Expansion part criteria in solid tumors (RECIST), version 1.1


Secondary Outcome Measures :
  1. Number of patients with adverse Events and serious adverse events [ Time Frame: 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 ]
    Continous Dosing and intermittent dosing "2days on/5days off

  2. Number of patients with adverse Events and serious adverse events [ Time Frame: 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 ]
    "Monday/ Thursday"

  3. Physical examination according to ECOG (Eastern Cooperative Oncology Group) Performance Status [ Time Frame: Cycle 1 on Day 8,15, Cycle 2 and subsequent cycles on Day1 , end of treatment up to 3 days after ]
    Continous Dosing

  4. Physical examination according to ECOG (Eastern Cooperative Oncology Group) Performance Status [ Time Frame: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1 , end of treatment up to 3 days after ]
    Intermittent Dosing "2days on/5days off"

  5. Physical examination according to ECOG (Eastern Cooperative Oncology Group) Performance Status [ Time Frame: Assessment on Day1,2, Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  6. Change in Pulse Rate [ Time Frame: 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 ]
    Continous Dosing

  7. Change in Pulse Rate [ Time Frame: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Intermittent Dosing "2 days on/5days off"

  8. Change in Pulse Rate [ Time Frame: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  9. Change in Temperature [ Time Frame: 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 ]
    Continous Dosing

  10. Change in Temperature [ Time Frame: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Intermittent Dosing "2days on/5days off"

  11. Change in Temperature [ Time Frame: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing " Assessment on Day1,2,Cycle 1 on Day 4,8,9,15

  12. Change in Respiratory Rate [ Time Frame: 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 ]
    Continous Dosing

  13. Change in Respiratory Rate [ Time Frame: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Intermittent Dosing "2days on/5days off"

  14. Change in Respiratory Rate [ Time Frame: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing " Monday/ Thursday"

  15. Change in Blood Pressure [ Time Frame: 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 ]
    Continous Dosing

  16. Change in Blood Pressure [ Time Frame: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Intermittent Dosing "2days on/5days off"

  17. Change in Blood Pressure [ Time Frame: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  18. Change in Blood Body Weight [ Time Frame: 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 ]
    Continous Dosing

  19. Change in Blood Body Weight [ Time Frame: Cycle 1 on Day 1,8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Intermittent Dosing "2days on/5days off"

  20. Change in Blood Body Weight [ Time Frame: Assessment on Day1,2,Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  21. Change in ECG [ Time Frame: 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 ]
    Continous Dosing

  22. Change in ECG [ Time Frame: After Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Intermittent Dosing "2days on/5days off" and "Monday/ Thursday"

  23. Depression test (PHQ-9) [ Time Frame: After Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Continous Dosing

  24. Depression test (PHQ-9) [ Time Frame: Cycle 1 on Day 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Intermittent Dosing "2days on/5days off" and "Monday/ Thursday"

  25. Generalized anxiety disorder mood scale score (GAD7) [ Time Frame: Cycle 1 on Day 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Continous Dosing and Intermittent Dosing "2days on/5days off" and "Monday/ Thursday"

  26. Changes in routine blood chemistry [ Time Frame: Cycle 1 on Day 1, 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Continous Dosing and Intermittent Dosing "2days on/5days off"

  27. Changes in routine blood chemistry [ Time Frame: 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 ]
    Intermittent Dosing "Monday/ Thursday"

  28. Changes of hematology [ Time Frame: Cycle 1 on Day 1, 8,15, Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Continous Dosing and Intermittent Dosing "2days on/5days off"

  29. Changes of hematology [ Time Frame: 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 ]
    Intermittent Dosing "Monday/ Thursday"

  30. Changes of insulin/Glucose/ C-peptide [ Time Frame: Assessment on Day 3, ,2,1 after baseline, Cycle 1 on Day 1, Cycle 2 and subsequent cycles on Day1 ]
    Continous Dosing

  31. Changes of insulin/Glucose/ C-peptide [ Time Frame: Assessment on Day 3, 2,1 after baseline, Cycle 8,9,15 on Day 1 ]
    " Intermittent Dosing "2days on/5days off""

  32. Changes of insulin/Glucose/ C-peptide [ Time Frame: Assessment on Day 1,2 after baseline, Cycle1 on Day 4, 8,9,15 ]
    " Intermittent Dosing "Monday/ Thursday"

  33. Changes of haemostasis [ Time Frame: Cycle 1 on Day 1, 8, 15 Cycle 2 and subsequent cycles on Day1, end of treatment up to 3 days after last medication ]
    Continous Dosing and Intermittent Dosing "2days on/5days off"

  34. Changes of haemostasis [ Time Frame: 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 ]
    Intermittent Dosing "Monday/ Thursday"

  35. Determination of Cmax [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1 ]
    Continous Dosing

  36. Determination of Cmax [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15 ]
    Intermittent Dosing "2days on/5days off"

  37. Determination of Cmax [ Time Frame: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  38. Determination of AUC 0-24 [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1 ]
    Continous Dosing

  39. Determination of AUC 0-24 [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15 ]
    Intermittent Dosing "2days on/5days off"

  40. Determination of AUC 0-24 [ Time Frame: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  41. Determination of tmax [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1 ]
    Continous Dosing

  42. Determination of tmax [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15 ]
    Intermittent Dosing "2days on/5days off"

  43. Determination of tmax [ Time Frame: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  44. Determination of AUClast (area under the curve) [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1 ]
    Continous Dosing

  45. Determination of AUClast [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15 ]
    Intermittent Dosing "2days on/5days off"

  46. Determination of AUClast [ Time Frame: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  47. Determination of AUC0-∞ [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1 ]
    Continous Dosing

  48. Determination of AUC0-∞ [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15 ]
    Intermittent Dosing "2days on/5days off"

  49. Determination of AUC0-∞ [ Time Frame: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  50. Determination of t 1/2 [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1 ]
    Continous Dosing

  51. Determination of t 1/2 [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15 ]
    Intermittent Dosing "2days on/5days off"

  52. Determination of t 1/2 [ Time Frame: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  53. Determination of RAC (Accumulation Ratio) [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,15, Cycle 2 on Day1 ]
    Continous Dosing

  54. Determination of RAC (Accumulation Ratio) [ Time Frame: Assessment on Day 3,2,1 after baseline, Cycle 1 on Day 8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  55. Determination of RAC (Accumulation Ratio) [ Time Frame: Assessment on Day 1,2 after baseline, Cycle 1 on Day 4,8,9,15 ]
    Intermittent Dosing "Monday/ Thursday"

  56. Determine Time to Response (TTR) [ Time Frame: up to 2 years ]
    Efficacy

  57. Determine Duration of Response (DOR) [ Time Frame: baseline and on Day 1 of every subsequential cycle which can be up to 24 months ]
    Defined as the time from the date of the first confirmed response to the first documentation of relapse or progressive disease, whichever occurs first

  58. Time to Treatment Failure (TTF) [ Time Frame: 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 ]
    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)

  59. Determine Progression Free Survival (PFS) [ Time Frame: baseline and on Day 1 of every subsequential cycle which can be up to 24 months ]
    Defined as the time from study entry to progression or death due to any cause

  60. 1- year Survival Rate [ Time Frame: baseline and on Day 1 of every subsequential cycle which can be up to 36 months ]
    Defined as the time from study entry to death as a result of any cause at 1-year cutoff date



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria

  1. Patients ≥ 18 years of age.
  2. Histologically or cytologically confirmed diagnosis of solid malignancy, for which no standard curative or life prolonging therapy is available.
  3. Have an ECOG Performance Status of ≤ 1. Refer to Appendix 1.
  4. Life expectancy of ≥ 12 weeks.
  5. Adequate bone marrow, liver, and renal functions, defined as:

    • Platelet count ≥ 100 x 109/L, absolute neutrophil count (ANC)

      ≥ 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).
  6. Glycated hemoglobin (HgbA1c) ≤ 7 %; Fasting Plasma Glucose (FPG) ≤ 7.0 mmol/L (125 mg/dL).
  7. Women of childbearing potential must have a negative pregnancy test (urine or serum) performed within 7 days prior to the start of study drug.
  8. Able and willing to swallow and retain oral medication.
  9. 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:

  10. Patients must have known PI3K/mTOR pathway gene aberrations (from molecular profiling studies).
  11. Patients must have HPV positive HNSCC containing activating PIK3CA mutations.

Exclusion Criteria

  1. 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.
  2. Hormonal anticancer therapies except for LHRH antagonists or LHRH agonists in hormone-refractory prostate cancer
  3. Patient has a known hypersensitivity to any of the excipients of PQR309.
  4. Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects.
  5. Patients with poorly controlled diabetes mellitus, steroid-induced diabetes mellitus, HbA1c > 7%, or FPG > 7.0 mmol/L (125 mg/dL).
  6. Patients who are on (or will require) prolonged systemic corticosteroid treatment during the study, except for:

    • 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);
  7. Patients who have taken herbal medications and certain fruits within 7 days prior to starting study drug, see section 11.1.2.7.
  8. 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.).
  9. Patient has a known history of HIV infection (testing not mandatory).
  10. 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.
  11. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug.
  12. 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.
  13. Patient has a history of non-compliance to medical regimen or inability to grant consent.
  14. 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.
  15. 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).
  16. 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.
  17. Patients with a history of interstitial

Information from the National Library of Medicine

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

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02483858


Locations
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, New York
Roswell Park Cancer
Buffalo, New York, United States, 14263
United States, Ohio
University Hospitals of Cleveland
Cleveland, Ohio, United States, 44106
United States, Texas
MD Anderson Cancer
Houston, Texas, United States, 77030
Spain
Vall d'Hebron University Hospital
Barcelona, Spain, 08035
Switzerland
Basel University Hospital
Basel, Switzerland, 4031
United Kingdom
University College Hospital London
London, United Kingdom
Churchill Hospital
Oxford, United Kingdom, OX3 7DQ
Sponsors and Collaborators
PIQUR Therapeutics AG
Roswell Park Cancer Institute
M.D. Anderson Cancer Center
Mayo Clinic
Hospital Clinic of Barcelona
University College London Hospitals
Churchill Hospital
Case Western Reserve University
University Hospital, Zürich
Investigators
Study Director: Mateusz Opyrchal Roswell Park Cancer Institute
Principal Investigator: Filip Janku MD Anderson Cancer
Principal Investigator: Afshin Dowlati University Hospitals Cleveland Medical Center
Principal Investigator: Alex Adjei Mayo Clinic
Principal Investigator: Jordi Rodon Vall d'Hebron University Hospital
Principal Investigator: Martin Forster University College London Hospitals
Principal Investigator: Sarah Bladgen Chruchill Hospital
Principal Investigator: Andreas Wicki Basel University Hospital

Responsible Party: PIQUR Therapeutics AG
ClinicalTrials.gov Identifier: NCT02483858     History of Changes
Other Study ID Numbers: PQR309-003
First Posted: June 29, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by PIQUR Therapeutics AG:
oncology, solid tumors