Medical Oncology Clinical Trial
Official title:
An Open-label, Non-randomized, Phase I Study to Evaluate the Effect of Itraconazole on the Pharmacokinetics of a Single Oral Dose of Roniciclib in Patients With Advanced Solid Tumors
Verified date | May 2016 |
Source | Bayer |
Contact | n/a |
Is FDA regulated | No |
Health authority | Canada: Health Canada |
Study type | Interventional |
To evaluate the effect of itraconazole, a strong CYP3A4 inhibitor, on the pharmacokinetics
of roniciclib in cancer patients.
To assess safety and tolerability of roniciclib dosing when administered with and without
itraconazole in cancer patients
Status | Completed |
Enrollment | 14 |
Est. completion date | April 2016 |
Est. primary completion date | February 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female patients = 18 years of age with histological or cytological confirmed advanced solid tumors refractory to, or not able to tolerate to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable. - Adequate liver, renal and bone-marrow functions as assessed by laboratory values. - ECOG Performance Status of 0 - 2 and life expectancy of at least 12 weeks. - Subject with a history of hypertension should be on a stable anti-hypertensive treatment for more than 7 days prior to the first dose of study drug. Exclusion Criteria: Medical and surgical history: - Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism. - History of cardiac disease: congestive heart failure, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted). - Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg despite optimal medical management) - Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C - Active clinically serious infections of Common Terminology Criteria for Adverse Events (CTCAE, v. 4.03) > Grade 2. - Symptomatic metastatic brain or meningeal tumors unless the subject is >3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry. - Seizure disorder requiring therapy (such as steroids or anti-epileptics). - History of organ allograft. - Use of strong inhibitors and/or inducers of CYP3A4 in the 14 days before study treatment |
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Bayer |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 1 (without itraconazole) | Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing | No | |
Primary | Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 1 (without itraconazole) | Cycle 1 Day 1: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48 and 72 hours after dosing | No | |
Primary | Maximum observed drug concentration (Cmax) of roniciclib on Cycle 1 Day 6 (with itraconazole) | Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing | No | |
Primary | Area under the concentration vs. time curve from zero to infinity (AUC) of roniciclib on Cycle 1 Day 6 (with itraconazole) | Cycle 1 Day 6: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, 24, 48, 72, 96 and 120 hours after dosing | No | |
Secondary | Collection of Adverse events as a measure of safety and tolerability of roniciclib dosing when administered with and without itraconazole | up to 15 months | Yes | |
Secondary | Laboratory analyses to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole | Complete blood count, Complete chemistry panel, Coagulation panel, Virology, Urinalysis, Pregnancy test | up to 15 months | Yes |
Secondary | Monitoring of vital signs to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole | up to 15 months | Yes | |
Secondary | East Coast Oncology Group (ECOG) performance status to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole | up to 15 months | Yes | |
Secondary | Electrocardiogram (12 lead ECG) readings to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole | up to 15 months | Yes | |
Secondary | Physical examination to assess safety and tolerability of roniciclib dosing when administered with and without itraconazole | up to 15 months | Yes | |
Secondary | Maximum observed drug concentration (Cmax) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole) | Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing | No | |
Secondary | Area under the concentration vs. time curve from zero to 24 hr (AUC) of roniciclib after a light meal on Cycle 1 Day -2 (without itraconazole) | Cycle 1 Day -2: pre-dose, 0.5, 1, 2, 3, 4, 6, 8, and 24 hours after dosing | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02824042 -
Thorough ECG (Electrocardiogram) and Drug Interaction Study With Anetumab Ravtansine and Itraconazole
|
Phase 1 | |
Completed |
NCT02253420 -
COPANLISIB (BAY80-6946) Drug-drug Interaction and Cardiovascular Safety Study in Advanced Solid Tumor and Non-Hodgkin's Lymphoma Patients
|
Phase 1 | |
Completed |
NCT02357953 -
Transpulmonary Thermodilution Using an Implented Central Venous Access Port
|
N/A | |
Completed |
NCT02645357 -
Implementing an Evidence-based Computerized Decision Support System Linked to Electronic Health Records to Improve Care for Cancer Patients
|
N/A | |
Recruiting |
NCT04931329 -
Onco-haematology Vigilance Card
|
||
Terminated |
NCT02138812 -
Phase I Dose Escalation of Oral BAY1161909 in Combination With Intravenous Paclitaxel
|
Phase 1 | |
Recruiting |
NCT05356182 -
A Pilot and Feasibility Study of a Dietary Intervention With Low-protein Meals in Cancer Patients Receiving Immunotherapies
|
N/A | |
Terminated |
NCT02368951 -
Phase I, Dose-escalation Trial of BAY1187982 in Subjects With Advanced Solid Tumors Known to Express Fibroblast Growth Factor Receptor 2 (FGFR2)
|
Phase 1 | |
Not yet recruiting |
NCT05423808 -
Geriatric and Oncological Evaluation With Technology for Holistic Healthcare Management for Older Multimorbid Patients.
|
N/A | |
Terminated |
NCT02439346 -
Phase I Dose Escalation and Expansion of Oral BAY 1143269 in Combination With Intravenous Docetaxel
|
Phase 1 | |
Recruiting |
NCT05385718 -
Ezra Faster Scan Study
|
||
Completed |
NCT02906423 -
Results From a Health System-wide Implementation of a Quality of Life Questionnaire
|
N/A | |
Completed |
NCT01409135 -
A Study of the Safety and Pharmacokinetics of AGS-22M6E in Subjects With Malignant Solid Tumors That Express Nectin-4
|
Phase 1 | |
Not yet recruiting |
NCT02327806 -
The Effect of Pullsed Magnetic Field Induction on Improving the Forearm Tissue Muscle Performance
|
N/A | |
Completed |
NCT02639091 -
Phase Ib Study of Anetumab Ravtansine in Combination With Pemetrexed and Cisplatin in Mesothelin-expressing Solid Tumors
|
Phase 1 | |
Completed |
NCT02366949 -
Phase I Study of Oral BAY 1217389 in Combination With Intravenous Paclitaxel
|
Phase 1 | |
Not yet recruiting |
NCT06097533 -
Improvement of Quality of Life by Cannabinoids in Oncologic Patients
|
Phase 2/Phase 3 | |
Completed |
NCT02427490 -
A Problem-Solving Intervention for Family Caregivers in Palliative Oncology
|
N/A | |
Recruiting |
NCT05359848 -
A Pilot, Feasibility Study of Intermittent Caloric Restriction Plus Plant-based Diet in Cancer Patients Receiving Chemotherapy
|
N/A |