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

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Abiraterone Acetate

Prednisone

Immunomodulating Agents

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

This multi-institution open label study has a Phase 1 and Phase 2 component. The Phase 1 dose escalation stage is to establish the tolerability of ipilimumab to be used in combination with the standard clinical dose of abiraterone acetate plus prednisone in chemotherapy and immunotherapy-naïve patients with progressive metastatic CRPC. Due to the overlapping potential hepatic toxicity between abiraterone and ipilimumab, a Lead in Therapy with abiraterone plus prednisone for 2 cycles will assess for adverse events related to the abiraterone plus prednisone. Patients, who tolerate well the Lead in therapy as defined by Grade 1 or less AEs, will pursue Combination Therapy. Patients with AEs Grade ≥ 2 after Lead in Therapy will be excluded and replaced. The Phase 2 stage will assess efficacy and confirm an acceptable safety profile of the recommended dose.

Abiraterone acetate (JanssenBiotech, Inc/Johnson \& Johnson) 1000 mg orally daily plus prednisone 5 mg orally twice daily will be administered continuously during the duration of the trial. Starting at cycle 3 (Combination Therapy), Ipilimumab (Bristol-Myers Squibb) will be infused intravenously (IV) once every 3 weeks for a total of 4 infusions.

Daniel C. Danila, MD

The purpose of this study is to find out what effects, good and/or bad, taking ipilimumab with abiraterone acetate plus prednisone has on the patient and the prostate cancer. Abiraterone acetate plus prednisone are drugs that lower testosterone (testosterone stimulates prostate cancer growth). Abiraterone acetate plus prednisone is a treatment for patients with prostate cancer.

Abiraterone acetate plus prednisone has not been used together with ipilimumab before. This study will test how they work together. Each patient will receive abiraterone acetate, prednisone and ipilimumab.

Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer

A Phase 2 Study Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer

AEs will be graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) grading scale, version 4.0.

which is defined as the time from the start of therapy until the criteria for progression are met

PSA levels will be assessed every 4 weeks during the Lead in Therapy, every 3 weeks during the Combination Therapy and every 4 weeks during the Maintenance Therapy. Outcomes will be reported both by the percent change in PSA from baseline and Week 21 (or earlier for those who discontinue therapy) and the maximum decline in PSA using a waterfall plot.

Measurable disease in viscera (liver or lung) is defined as per PCWG2 modified RECIST 1.1 as a lesion ≥10 mm in its longest diameter as measured with conventional techniques (ie, CT or MRI). For a lymph node to be considered measurable, the minimum diameter must be ≥20 mm in long axis when assessed by CT scan. All other lesions (or sites of disease) will be considered nonmeasurable disease.

Radionucleotide bone scan outcome should be recorded as either new lesions or no new lesions. On bone scan, progression of bone metastases is defined as the appearance of 2 or more new bone lesions compared to the baseline scan. In the case of the first Week 8 and Week 16 assessment scans a confirmatory scan performed 6 weeks later needs to shows 2 or more additional new lesions (for a total of at least 4 new lesions seen since baseline) for progression to be documented (the date of progression is always the date of the first scan showing the change).

Bristol-Myers Squibb

Northwestern University

Oregon Health and Science University

Memorial Sloan Kettering Cancer Center

Docetaxel

MDV3100

Use Central Contact

This study is to evaluate safety, tolerability pharmacokinetics and efficacy of MDV3100 after oral administration to patients with castration-resistant prostate cancer.

This is a Phase1/2, open-label, uncontrolled study, involving Dose-Escalation Cohorts, where dose will be escalated to next dose with the safety, tolerability, and PK being evaluated in metastatic castration-resistant prostate cancer (mCRPC) patients and an Expansion Cohort, where the efficacy, safety, and PK of MDV3100 in post-chemo mCRPC patients will be evaluated. After evaluation of the safety and tolerability in Dose-Escalation Cohorts, additional patients are included in Expansion Cohort.

A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients

A Phase I/II, Open-Label, Uncontrolled, Dose-Escalation Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer

Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."

This measure will be assessed on the dose escalation cohorts.

This measure will be assessed on the dose expansion cohort

This measure will be assessed on the dose expansion cohort.

Medivation LLC, a wholly owned subsidiary of Pfizer Inc.

Astellas Pharma Inc

Respiratory Tract (Lung and Bronchial) Diseases

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Lymphoma

Lymphoma, Follicular

Carcinoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lymphoma, Non-Hodgkin

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Lymphosarcoma

Follicular Lymphoma

Participants with SCLC, CRPC and FL will receive PF-06821497 at escalating dose levels

Participants with FL will receive PF-06821497 at escalating dose levels

Participants with CRPC will receive PF-06821497 at escalating dose levels.

Participants with CRPC and SCLC will receive PF-06821497 at escalating dose levels in combination with SOC.

Participants with CRPC will receive PF-06821497 in combination with SOC or SOC alone.

Participants with CRPC will receive PF-06821497 at one or two doses

Participants will receive PF-06821497 at one or two doses

PF-06821497

Pfizer CT.gov Call Center

A Phase 1 Dose Escalation and Expanded Cohort Study Of PF-06821497 In The Treatment Of Adult Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL).

This is an open label, multi center, Phase 1 dose escalation and dose expansion study of PF-06821497 administered orally BID as a single agent or in combination with SOC to patients with CRPC, SCLC, and FL. Part 1A will evaluate safety and target modulation of PF-06821497 monotherapy in patients with SCLC, FL and CRPC. PF-06821497 will be administered as monotherapy in patients with FL in Part 1B dose escalation and to patients with CRPC in Part 1C dose escalation. For Part 2A (dose escalation combination therapy), PF-06821497 will be administered in combination with SOC in patients with CRPC and SCLC. For Part 2B (dose expansion), patients with mCRPC will be randomized (1:1 ratio) to receive either SOC or PF-06821497 in combination with SOC. Once safety and adequate target modulation has been established in Part 1A, Parts 1B and 2A of the trial will be initiated. Part 1C (monotherapy dose escalation) will determine the MTD of single agent PF-06821497 in patients with mCRPC. Japan and China monotherapy cohorts will evaluate the safety, antitumor activity and PK of single agent PF-06821497 in Japanese and Chinese patients. Part 2A (escalation RP2D finding for combination) will determine the MTD of the combination with SOC in patients with CRPC. Part 2B (dose expansion) will assess the efficacy of PF-06821497 at the RP2D in combination with SOC in patients with mCRPC in comparison to SOC alone. The study is currently enrolling Part 2B.

PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma

A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF-06821497 IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED/REFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

First cycle DLTs will be utilized to determine the MTD

Adverse Events will be graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version \[4.03\])

Objective response using Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC). Progression-free survival in Part 2B in patients with CRPC.

Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version \[4.03\]), and timing.

Vital sign changes from baseline including blood pressure, heart rate, ECG changes.

Time to event endpoints based on Response Evaluation Criteria in Lymphoma (RECIL) for lymphoma, Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 for solid tumors including Small Cell Lung Cancer (SCLC) and Prostate Cancer Working Group 3 (PCWG3) for Castration Resistant Prostate Cancer (CRPC)

Median time to death proportion of patients alive at 6 months, 1 year, and 2 years.

Single dose and multiple dose PK will be calculated as data permits

Singe dose and multiple dose PK will be calculated as data permits

Quality of Life and Time to Functional Status Deterioration as assessed by FACT-P.

Pfizer

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

Anticoagulants

Hypoglycemic Agents

Gastrointestinal Agents

Midazolam

Warfarin

Pioglitazone

Omeprazole

Anesthetics

Hypnotics and Sedatives

Anti-Anxiety Agents

Anesthetics, Intravenous

Anesthetics, General

GABA Modulators

Neurotransmitter Agents

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Multiple doses of MDV3100 and a single dose of pioglitazone and a single dose of cocktail containing -warfarin, omeprazole and midazolam

Operation Senior Research Manager

A drug-drug interaction study to investigate the potential pharmacokinetic interaction between MDV3100 and a cocktail of substrates for pioglitazone (CYP2C8 substrate), S-warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and midazolam (CYP3A4 substrate).

Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates

A Phase I Open-label Study to Evaluate the Effect of Multiple Doses of MDV3100 (ASP9785) on the Pharmacokinetics of Substrates for CYP2C8, CYP2C9, CYP2C19, and CYP3A4 in Patients With Castration-resistant Prostate Cancer

(Maximum concentration (observed))Cmax, (Area Under Curve from the time of dosing to the last measurable concentration)AUC0-t, (AUC extrapolated to infinity)AUC0-inf

(Time to attain Cmax)tmax (Apparent terminal elimination half-life)t1/2, (Apparent total body clearance after extravascular dosing)CL/F, (Apparent volume of distribution during the terminal phase after extravascular dosing)Vz/F, Cmax, AUC0-t, AUC0-inf, (Pre-dose plasma concentration)C0h, (Minimum concentration (observed))Cmin, (AUC between two consecutive doses at steady-state)AUCtau, (Peak-trough ratio)PTR

Medivation, Inc.

Astellas Pharma Europe B.V.

Androgens

Androgen Antagonists

Norio Nonomura, MD, Ph.D.

This is a prospective observational study to evaluate effectiveness and safety of Enzalutamide for Castration Resistant Prostate Cancer (CRPC) patients who decided to administer Enzalutamide after anti-androgen therapy.

CRPC Patients who are observed PSA or disease progression after anti-androgen therapy and decided to administrate Enzalutamide will dose the Enzalutamide 160 mg orally once daily and observed the practical treatment. Total research term is for 4 years, consists of 2-year case registration terms and 2-year observational terms.

A Study to Determine Enzalutamide Long-term Safety and Efficacy After Anti-androgen Therapy for CRPC

OS is defined as time from date of initial dose until date of death from any cause. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied. When patient is no longer traceable, the final confirmed date as alive will be applied to OS.

Prostate specific antigen (PSA) progression-free survival is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of \>= 25% and \>= 2 ng/ml above the nadir after initial dose) or date of death from any cause, whichever comes first. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied.

PFS is defined as time from date of initial dose until the date of first confirmed progression or date of death from any cause, whichever comes first. Progression is defined as followed:① A growth of primary lesion or appearance of neopathy by image diagnosis, aggravation of general condition・PS decrease or noticable weight loss which investigator assess as progression. ②Unmeasurable or difficult to measure lesion which newly appeared or investigator assess as obvious aggravation. ③ In the case of any new chemotherapy added or changed to another treatment to prostate cancer

TTTF is defined as time from date of initial dose until the date of any new chemotherapy added or changed to another treatment to prostate cancer.

TTPP is defined as time from date of initial dose until the date of first confirmed PSA progression (an increase in PSA of \>= 25% and \>= 2 ng/ml above the nadir after initial dose). In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied.

PSA response rate is defined as ratio of patients who have an decrease in PSA of \>= 50% above baseline since initial dose.

TTFS is defined as time from date of initial dose until the date of first confirmed skeletal-related event. In the case of any new chemotherapy added or changed to another treatment to prostate cancer, the conducted date will be applied. Symptomatic Skeletal Events (SSE) defined as followed: ・Operation of EBRT External Beam Radiation Therapy (EBRT) to mitigate skeletal events ・New appearance of symptomatic pathological fracture ・Appearance of spinal cord compression ・Orthopedic intervention related to tumor

The state of administration is assessed by Relative Dose Intensity (RDI). RDI is calculated by dosage and dosing period. RDI calculation formula =∑ (daily dosage ×dosing days) / (160mg ×total dosing number of days). ∑ means all total dose which adds up in different dosage. Total number of days mean treatment term of this trial.

Safety assessment by the incidence and severity of adverse events as assessed by Japanese version of the Common Terminology Criteria for Adverse Events (CTCAE) version 4.00

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer	NCT01688492	Prostate Cancer	Ipilimumab	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients	NCT01284920	Prostate Cancer Prostate Neopla... Castration Resi...	MDV3100	20 Years -	Astellas Pharma Inc
PF-06821497 Treatment Of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma	NCT03460977	Castration Resi... Small Cell Lung... Follicular Lymp...	PF-06821497	18 Years -	Pfizer
Combining Ipilimumab With Abiraterone Acetate Plus Prednisone in Chemotherapy and Immunotherapy-naïve Patients With Progressive Metastatic Castration-resistant Prostate Cancer	NCT01688492	Prostate Cancer	Ipilimumab	18 Years -	Memorial Sloan Kettering Cancer Center
A Study of MDV3100 to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of in Prostate Cancer Patients	NCT01284920	Prostate Cancer Prostate Neopla... Castration Resi...	MDV3100	20 Years -	Astellas Pharma Inc
Drug-drug Interaction Study With MDV3100 and a Cocktail of Substrates	NCT01911728	Pharmacokinetic... Castration Resi...	MDV3100 Pioglitazone Warfarin Omeprazole Midazolam	18 Years -	Astellas Pharma Inc
A Study to Determine Enzalutamide Long-term Safety and Efficacy After Anti-androgen Therapy for CRPC	NCT02669147	Castration Resi...		20 Years -	Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

Spots Global Cancer Trial Database for castration resistant prostate cancer (crpc)