Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

ZEN003694 will be administered orally as a single agent once daily in 28-day cycles, enrolling mCRPC patients.

ZEN003694

This is an open label, Phase 1, dose escalation and dose confirmation study of ZEN003694 in patients with mCRPC.

A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer

A Phase 1 Safety and Tolerability Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer

A DLT is a treatment-related, clinically significant adverse event or laboratory abnormality occurring during the first cycle of treatment (Day 1 thru Day 28).

AUC is defined as the area under the curve (plasma concentration of drug over time).

Cmax is defined as maximum or peak plasma concentration of drug.

Cmin is defined as minimum or trough plasma concentration of drug.

Tmax is defined as the time from dosing to the maximum plasma concentration.

t/12 is defined as the half-life of drug.

Zenith Epigenetics

Blood and Lymph Conditions

Immune System Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Carcinoma

Lymphoma, Large B-Cell, Diffuse

Sarcoma

Lymphoma

Hematologic Neoplasms

Lymphoma, Follicular

Mesothelioma

Mesothelioma, Malignant

Lymphoma, B-Cell

Carcinoma, Medullary

Sarcoma, Synovial

Rhabdoid Tumor

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Neoplasms, Connective and Soft Tissue

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms, Mesothelial

Hematologic Diseases

Neoplasms, Connective Tissue

Carcinoma, Neuroendocrine

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Adenocarcinoma

Neoplasms, Nerve Tissue

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Soft Tissue Sarcoma

Lymphosarcoma

Follicular Lymphoma

Malignant Mesothelioma

Thyroid Cancer, Medullary

Renal Medullary Carcinoma

Synovial Sarcoma

Epithelioid Sarcoma

Neuroendocrine Tumor

Neuroepithelioma

Anti-Infective Agents

All Drugs and Chemicals

Itraconazole

Rifampin

Hydroxyitraconazole

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Hormones

Hormone Antagonists

Cytochrome P-450 CYP3A Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antitubercular Agents

Participants in Part 1 of the study will receive a single oral, 400 mg dose of tazemetostat on Day 1, 15, and Day 36.

The study participants will receive tazemetostat (oral 400 mg) tablets to be taken twice daily on Days 3 - 14 and Days 21 - 35. In addition, the participants will receive oral 200 mg itraconazole once daily on Days 18 - 38.

Study participants may continue tazemetostat from Day 40+ at the recommended therapeutic dose (oral 800 mg twice daily) in 28-day cycles.

Participants in Part 2 of the study will receive a single oral, 800 mg dose of tazemetostat on Days 1, 15, and Day 36.

The study participants will receive tazemetostat (oral 800 mg dose) tablets to be taken twice daily on Days 3 - 14 and Days 17 - 23. In addition, the participants will receive oral 200 mg rifampin once daily on Days 17 - 25.

Study participants may continue tazemetostat from Day 27+ at the recommended therapeutic dose (oral 800 mg twice daily) in 28-day cycles.

A single, oral, 400 mg dose of tazemetostat on Day 1, Day 15, and Day 36; and tazemetostat (oral 400 mg) tablets twice daily on Days 3 - 14 and Days 21 - 35.

Tazemetostat

Oral 200 mg itraconazole once daily on Days 18 - 38

A single, oral, 800 mg dose of tazemetostat on Days 1, 15, and Day 24 ; and tazemetostat (oral 800 mg) twice daily on Days 3 - 14 and on Days 17 - 23.

Oral 600 mg rifampin once daily on Days 17 - 25.

Ipse Medical Director

The participants of this study will have advanced malignancies (also known as advanced cancer). The main aim of this trial will be to study the blood levels (known as pharmacokinetics) of the tazemtostat (the study drug) when administered in combination with another drug.

Part 1 of the study will evaluate the interaction between the drugs tazemetostat and itraconazole.

Part 2 of the study will evaluate the interaction between the drugs tazemetostat and rifampin

For both Parts 1 and 2, safety and the level that effects of the study drug can be tolerated (known as tolerability) will be assessed throughout.

This two-part study is designed to characterize the steady-state PK of oral tazemetostat and its metabolite EPZ 6930 when administered as a single and twice daily dose in subjects with advanced malignancies while taken alone or in combination with either itraconazole or rifampin.

Part 1: tazemetostat and Itraconazole Drug Interaction Part 1 of the study will evaluate the drug-drug interaction between tazemetostat and itraconazole in an open-label, fixed sequential cross over design.

Part 2: tazemetostat and Rifampin Drug Interaction Part 2 of the study will evaluate the drug-drug interaction between tazemetostat and rifampin in an open-label, fixed sequential cross over design.

For both Parts 1 and 2, safety and tolerability will be assessed throughout the subject's participation. Subjects must have an end of study visit after 30 days of the last dose of tazemetostat for safety assessment.

Study to Describe the Interaction Between Tazemetostat and Itraconazole and Between Tazemetostat and Rifampin in Participants With Advanced Cancer

A Phase I, Open-label Multi-dose Two-part Study to Characterize the Effects of a Strong CYP3A4 Inhibitor and a Strong CYP3A4 Inducer on the Steady-State Pharmacokinetics of Tazemetostat (EPZ-6438) in Subjects With Advanced Malignancies

Severity of adverse events experienced by all subjects with at least 1 dose or partial dose of tazemetostat will be evaluated by the Investigator based on the CTCAE, version 5.0.

Percentage of participants with clinically significant changes in physical examination findings will be reported. The clinical significance will be graded by the investigator.

Percentage of participants with clinically significant changes in Vital Signs will be reported. The clinical significance will be decided by the investigator.

Percentage of participants with clinically significant changes in ECG readings will be reported. The clinical significance will be graded by the investigator.

ECOG is a 4-point performance status scale used to assess performance as a key indicator (e.g., 0 = fully active, 2 = up and about more than 50% of walking hours, 4 = Completely disabled). Performance status will be assessed per usual clinical practice and will be recorded in the medical record.

All prior medications administered 30 days before study drug administration will be recorded.

Epizyme, Inc.

Symptoms and General Pathology

Recurrence

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

Amino Acids

Mitogens

Dasatinib

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Erlotinib in combination with Dasatinib

Eric B. Haura, MD

This is a single site phase I dose escalation trial of the epidermal growth factor receptor inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with previously treated advanced stage (Stage IIIB/IV disease) Non-Small Cell Lung Cancer (NSCLC). The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets starting Day 9 for a 28-day cycle. If there are no Dose Limiting Toxicities (DLTs), dose escalation continues. The recommended phase II dose for this combined treatment will be defined and patients will be treated at the recommended phase II dose to confirm tolerability.

This is a single site Phase I dose escalation trial of the epidermal growth factor receptor inhibitor Erlotinib with the SRC tyrosine kinase inhibitor Dasatinib in patients with previously treated advanced stage (Stage IIIB/IV disease) Non-Small Cell Lung Cancer (NSCLC). The screening evaluation will consist of a medical history including dates/description of your initial NSCLC diagnosis and documentation of any previous treatment. There will also be a physical examination including vital signs, height, weight, Eastern Cooperative Oncology Group (ECOG)performance status, blood draws for Complete Blood Count (CBC) and Complete Metabolic Panel (CMP) tests, neurological examination, a pregnancy test for female patients of childbearing potential, and (if applicable) any observable tumor measurements all within 14 days before study enrollment. A screening Electrocardiogram (EKG) as well as clinical testing to evaluate all known sites of malignant lesions, including Computed Tomography (CTs) of the chest and upper abdomen, the adrenal glands; ultrasound; or radionuclide scans of the bones; and/or other radiographic studies should be performed within 30 days prior to enrollment.

The treatment regimen consists of Erlotinib tablets starting Day 1 and Dasatinib tablets starting Day 9 for a 28-day cycle. If there are no DLTs, dose escalation continues. Patients continuing on therapy past two cycles will be seen by the treating physician every 4 weeks and will have complete History and Physical (H\&P), CBC, and CMP. Tumor measurement and response assessment will occur every 6-8 weeks. Dasatinib and Erlotinib will be continued until progression of disease, unacceptable toxicity, or patient request.

The recommended phase II dose for this combined treatment will be defined and patients will be treated at the recommended phase II dose to confirm tolerability.

Phase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC)

Phase I Trial Evaluating the Epidermal Growth Factor Receptor Inhibitor Erlotinib in Combination With the SRC Kinase Inhibitor Dasatinib for Patients With Recurrent Non-small Cell Lung Cancer (NSCLC)

Determine the safety and tolerability of erlotinib in combination with dasatinib in patients with advanced NSCLC

Determine the MTD of erlotinib in combination with dasatinib and the phase II dose

Characterize the pharmacokinetics of the erlotinib/dasatinib combination

Assess serum angiogenic markers as pharmacodynamic markers of treatment

Estimate the objective response rate (CR and partial response PR). Partial Response is defined as at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Complete Response is defined as disappearance of all target lesions.

Estimate the 6-month progression free survival rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of ZEN003694 in Patients With Metastatic Castration-Resistant Prostate Cancer	NCT02705469	Metastatic Cast...	ZEN003694	18 Years -	Zenith Epigenetics
Study to Describe the Interaction Between Tazemetostat and Itraconazole and Between Tazemetostat and Rifampin in Participants With Advanced Cancer	NCT04537715	All Malignancie... Advanced Malign... Hematologic Mal... Solid Tumor Follicular Lymp... Non-Hodgkin Lym... Diffuse Large B... Epithelioid Sar... Synovial Sarcom... Renal Medullary... Mesothelioma Rhabdoid Tumor	Tazemetostat Itraconazole Tazemetostat Rifampin	18 Years -	Ipsen
Phase I Dasatinib/Erlotinib in Recurrent Non-small Cell Lung Cancer (NSCLC)	NCT00444015	Non-Small-Cell ...	Erlotinib in co...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for pharmacokinetics (pk)