| Titre |
An Open-label, First-in-human, Dose-escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Maximum Tolerated Dose and / or Recommended Phase II Dose of the ATR Inhibitor BAY1895344 in Patients With Advanced Solid Tumors and Lymphomas |
| Protocole ID |
18594 |
| ClinicalTrials.gov ID |
NCT03188965 |
| Type(s) de cancer |
Tumeurs solides |
| Phase |
Phase I |
| Type étude |
Traitement |
| Médicament |
BAY 1895344 |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 L'HOTEL-DIEU DE QUEBEC ET CRCEO
11 Côte du Palais, Québec, QC, G1R 2J6
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dr Vincent Castonguay
|
| Coordonnateur(trice) |
Marie-Pierre Brochu
418-525-4444 poste 15768
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
- Part A - single-agent dose-escalation part: Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma (NHL).
- Part B - single-agent expansion part:
- Patients with DNA Damage Response (DDR) defects or Mismatched Repair (MMR) deficiency putative biomarker-positive advanced solid tumors of the following histologies: i) castration-resistant prostate cancer (CRPC); ii) lung cancer, including adenocarcinoma, squamous carcinoma, or small cell lung cancer (SCLC); iii) colorectal cancer (CRC) and iv) gynecological tumors (ovarian cancer, endometrial cancer, or cervical cancer).
- Patients with advanced mantle cell lymphoma (MCL). Patients with diffuse large B cell lymphoma (DLBCL) known to be positive for DDR defects.
- Part C (dose escalation in combination with radium-223 dichloride) Castration-resistant prostate cancer with symptomatic bone metastases (positive bone scan the last 3 months) and no known visceral metastatic disease.
- The following inclusion criteria apply to ALL (dose-escalation and expansion) patients:
- Patients with tumors resistant or refractory to standard treatment and for which, in the opinion of the investigator, experimental treatment with BAY1895344 may be of benefit, or patients who refused standard treatment
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
-
Adequate bone marrow function as assessed by the following laboratory tests
- Part A + B: Hemoglobin (HB) >=8.5 g/dL; patients with chronic erythropoietin treatment consistent with institutional guidelines can be included Part C:Hemoglobin ≥9.0 g/dL
- Platelet count >=100,000/mm*3
- Absolute neutrophil count (ANC) >=1500/mm*3
|
| Critètes d'exclusion |
- Known hypersensitivity to the study drugs or excipients of the preparations or any agent given in association with this study
- History of cardiac disease: congestive heart failure New York Heart Association (NYHA) class >II, unstable angina (angina symptoms at rest), new-onset angina (within the past 6 months before study entry), myocardial infarction within the past 6 months before study entry, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers, calcium channel blockers, and digoxin are permitted)
- Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C
- Patients with known human immunodeficiency virus (HIV) infection
- Patients who have an active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection requiring treatment. Patients with chronic HBV or HCV infection are eligible at the investigator's discretion provided that the disease is stable and sufficiently controlled under treatment.
- Infections of CTCAE(Common Terminology Criteria for Adverse Events Version) Grade 2 not responding to therapy or active clinically serious infections of CTCAE Grade >2
|
Groupe d'étude en oncologie du Québec