Symptoms and General Pathology

All Conditions

Flushing

Skin Manifestations

Michael McNamara, MD

This study is to compare the rate of adverse events in subjects with maintenance flushes greater than 28 days.

This study is a retrospective, multi-center data collection study to support extending the maximum recommended maintenance flushing intervals in subjects who have Bard totally implanted ports with distally-valved catheters.

This study is intended to provide clinical evidence in support of extending the maximum recommended maintenance flushing interval to a time point of potentially \>28 days for Bard ports with distally-valved catheters.

Reduction in the number of maintenance flushes could help alleviate the inconvenience, reduce the time and expense, and minimize the invasive nature of the maintenance flushing procedure for patients and medical institutions. Subjects will be eligible for analysis of the primary endpoint after the first successful maintenance flush of the port until (a) the first adverse event or (b) abandonment of the port.

A financial analysis will be performed on an institutional basis to determine the approximate mean cost of flushing. These costs will be extrapolated into an approximate per-patient cost for the different flushing period durations. No financial information will be collected from subject medical records. All required information will be extrapolated from site staff.

Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

A Retrospective Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters

Study was terminated due to limited number of adverse events recorded.

Subjects' maintenance flush intervals were collected by calculating the number of days since a previous flush. A total of 1,035 maintenance flush intervals were recorded at all sites. The numbers of flushing intervals available for analysis are 1,035 representing 49,696 patient days were recorded in 171 subjects.

C. R. Bard

Adverse events were assessed separately for each flushing interval, and not for each participant

Group A

Group B

Group C

Demographics of 171 subjects that contributed to final data analysis

Combined Demographics

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Ethnicity (NIH/OMB)

United States

Region of Enrollment

Solid tumor

Hematologic

Cancer Type

Jugular

Subclavian

Unknown

Port Access Vein

Single Lumen

Dual Lumen

Port Configuration

7Fr.

8Fr.

9.5Fr.

#Fr. (French units) refers to the functional lumen/relative size of the catheter's diameter with smaller numbers indicating smaller diameters. Each increment of French sizing equals 0.33 mm.

Catheter Configuration

Post-infusional chemotherapy subjects that had Bard implanted ports with distally valved catheters.

Christopher DiMatteo

The Rate of Adverse Events in Group A (1-28 Day Flushing Interval) Versus Extended Accession Intervals in Group B (29-56 Day Flushing Interval), and Group C (57+ Days).

Overall Study

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Neoplasms by Histologic Type

Hematologic Diseases

Myeloproliferative Disorders

Bone Marrow Diseases

Chronic Disease

Disease Attributes

Myeloid Leukemia

Chronic Graft Versus Host Disease

Chronic Myeloid Leukemia

Chronic Myeloproliferative Disorders

All Drugs and Chemicals

Amino Acids

Bosutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg.

bosutinib

Pfizer CT.gov Call Center

The objective of the study is to provide long term access to bosutinib treatment and assess long term safety, tolerability and duration of clinical benefit, without any formal hypothesis testing; therefore, there is no formal primary endpoint.

Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008

AN OPEN-LABEL BOSUTINIB TREATMENT EXTENSION STUDY FOR SUBJECTS WITH CHRONIC MYELOID LEUKEMIA (CML) WHO HAVE PREVIOUSLY PARTICIPATED IN BOSUTINIB STUDIES B1871006 OR B1871008

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.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. Treatment-emergent adverse events were defined as any event increasing in severity from baseline or any new event started during bosutinib therapy or within 30 days of the last dose of study drug.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. AEs were assessed according to severity grading based on NCI CTCAE version 3.0. Grade 1 =mild; Grade 2 =moderate; Grade 3 =severe or medically significant but not immediately life-threatening, hospitalization or prolongation of hospitalization indicated; Grade 4 =life-threatening or disabling, urgent intervention indicated; Grade 5 =death. Treatment-emergent adverse events were defined as any event increasing in severity from baseline or any new event started during bosutinib therapy or within 30 days of the last dose of study drug.

An AE was any untoward medical occurrence in a participant who received study drug. Treatment-emergent adverse events were defined as any event increasing in severity from baseline or any new event started during bosutinib therapy or within 30 days of the last dose of study drug. Related TEAEs were those AEs who were related to the study treatment as judged by the investigator.

Laboratory parameters included Chemistry: high alkaline phosphatase; high alanine aminotransferase; high aspartate aminotransferase; high blood bilirubin; high creatinine. Hematology: absolute neutrophils count decreased; anemia; platelet count decreased; white blood cells (WBC) decreased. Abnormalities in laboratory tests were graded per NCI CTCAE version 4.03 as Grade 1= mild; Grade 2= moderate; Grade 3= severe and Grade 4= life-threatening or disabling.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.

The incidence of diarrhea was collected and analyzed before and after the switch from the clinical formulation of bosutinib to the commercial formulation of bosutinib.

BCR-ABL is a gene resulting from the 9:22 chromosomal translocation (Philadelphia chromosome). In this outcome measure, the number of participants who had emergent mutation or new BCR-ABL mutations (participants who had a post-baseline mutation which was not present at baseline) were reported.

OS was defined as the time from randomization (B1871008) and time from first dose (B1871006) to the occurrence of death due to any cause or censoring. Kaplan-Meier analysis was used for determination of OS. Percentage of participants who were alive were estimated in this outcome measure.

Ctrough refers to plasma concentration of bosutinib observed just before treatment administration.

Cytogenetic response (CyR) is based on prevalence of Ph+ cells. Duration for MCyR: time from first response to confirmed loss, progression of disease, or on-treatment death due to any cause, or censoring analyzed for responders only. Confirmed loss was defined as 2 consecutive non-responses at least 28 days apart. MCyR was categorized as either complete cytogenetic response (CCyR) or partial cytogenetic response (PCyR). Response was achieved when there was 0% (CCyR) or 1-35% (PCyR) Ph+ cells analyzed from conventional cytogenetics based on the analysis of 20 to 100 metaphases or \<1% (CCyR) or 1-35% (PCyR) Ph+ cells analyzed from fluorescence in-situ hybridization (FISH) based on analysis of at least 200 nuclei. CCyR may be imputed on a specific date if an MMR or better is achieved and denoted on the CRF on that date for B1871040 study visits. The Kaplan-Meier analysis was used to analyze percentage of participants maintaining MCyR at Year 10.

Duration for CCyR was defined as time from first response to confirmed loss, progression of disease, or on-treatment death due to any cause, or censoring analyzed for responders only. Confirmed loss was defined as 2 consecutive assessments with \>0 Ph+ metaphases or \>=1% positive cells from FISH at least 28 days apart or progression or death. CCyR was achieved when there was 0% Ph+ cells analysed from conventional cytogenetics with 20 to 100 metaphases or \<1% Ph+ cells analysed from FISH with at least 200 nuclei. CCyR may be imputed on a specific date if MMR or better is achieved and denoted on the CRF on that date for B1871040 study visits. The Kaplan-Meier analysis was used to analyze percentage of participants maintaining CCyR at Year 10.

Duration for CHR was defined as time from first response to confirmed loss, progression of disease, or on-treatment death due to any cause, or censoring analyzed for responders only. Confirmed loss was defined as 2 consecutive non-responses at least 14 days apart. Complete hematologic response was considered when participants met all of the following criteria: White blood cells equal to or less than (\<=) institutional upper limit of normal (ULN), no blasts or promyelocytes in blood, \<20% basophils in blood, no extramedullary involvement (including hepatomegaly or splenomegaly), myelocytes and metamyelocytes \<5% in blood, platelets \<450\*10\^9 per liter (/L). The following were applicable only to advanced phase: \<=5% bone marrow blasts, absolute neutrophil count \>=1.0\*10\^9/L, platelets \>=100\*10\^9/L. The Kaplan-Meier analysis was used to analyze percentage of participants maintaining CHR at Year 10.

Progression free survival (PFS):interval from date of first dose of bosutinib in parent study until earlier date of progression or death from any cause. Participants without events censored at last evaluation date. PD:evolution from CP (or return to CP for ADV participants) to AP or BP (on 2 consecutive assessments at least 1 week apart), evolution from AP to BP (on 2 consecutive assessments at least 1 week apart) and one of following conditions occurred after dose escalation or presence of AEs prohibiting dose escalation: for 2nd or later line, loss of MCyR (need at least 30% increase); for all lines of treatment, loss of CHR confirmed by 2 assessments \>=2 weeks apart; for all lines of treatment, increasing WBC defined as doubling of WBC over a period of \>=1 month with second WBC \>20\*10\^9/L confirmed at least 1 week later. Percentage of participants with PFS/death events based on cumulative incidence method adjusting for competing event of treatment discontinuation without event.

Time to transformation was defined as the time from first dose in the parent study to the first date of confirmed transformation to AP or BP. Confirmed transformation was defined as 2 consecutive assessments at least 1 week apart or 1 assessment confirmed by progression of disease or death. For participants without transformation, censorship was at the last evaluation date. Percentage of participants with time to transformation to AP/BP was reported based on cumulative incidence method adjusting for the competing risk of treatment discontinuation without the event.

Pfizer

All-cause mortality: The total number of deaths during study, from randomization (B1871008)/first dose (B1871006) and up to the end of the study are reported for all treated participants and includes deaths which occurred after 30 days post last study drug dose. SAEs and other AEs: Analysis performed on safety set. Data from the 2 parent studies was combined with the data from this study for the analysis of safety as planned.

Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML).

Bosutinib, CP1L

Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib.

Bosutinib, CP2L

Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib.

Bosutinib, CP3L/CP4L

Participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML or Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant and intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib.

Bosutinib, ADV

Participants from B1871008 CP1L cohort and B1871006 CP2L, CP3L/CP4L and ADV cohorts.

Bosutinib, Total

Total

The full analysis set included all participants randomized to the bosutinib arm from B1871008 and all dosed participants from B1871006.

Pfizer ClinicalTrials.gov Call Center

Treatment-Emergent AEs

Treatment-emergent SAEs

Safety analysis set included all dosed participants for both B1871006 and B1871008.

Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)

Number of Participants With Grade 3 or 4 Treatment-Emergent Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)

Number of Participants With Treatment-Emergent Treatment Related Adverse Events (AEs) Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 3.0)

Grade 1

Grade 2

Grade 3

Grade 4

Number of Participants With Laboratory Test Abnormalities Based on National Cancer Institute Common Terminology Criteria for AEs (NCI CTCAE) (Version 4.03)

Number of Participants With Adverse Events as Reason for Treatment Discontinuation

Clinical formulation (last 6 months)

Commercial formulation (first 6 months)

Safety analysis set included all dosed participants for both B1871006 and B1871008. Here, 'Overall number of participants analyzed'= participants evaluable for this outcome measure who received commercial formulation.

Number of Participants With Diarrhea After Switch From Bosutinib Clinical Formulation to Bosutinib Commercial Formulation

Number of Participants With Breakpoint Cluster Region Abelson Protooncogene (BCR-ABL) Mutations Present at Time of Bosutinib Treatment Discontinuation

Overall Survival (OS) Rate at Year 10

Participants received uninterrupted once daily oral 200 mg dose of bosutinib for at least 2 weeks in study B1871040.

Bosutinib 200 mg

Participants received uninterrupted once daily oral 300 mg dose of bosutinib for at least 2 weeks in study B1871040.

Bosutinib 300 mg

Participants received uninterrupted once daily oral 400 mg dose of bosutinib for at least 2 weeks in study B1871040.

Bosutinib 400 mg

Participants received uninterrupted once daily oral 500 mg dose of bosutinib for at least 2 weeks in study B1871040.

Bosutinib 500 mg

Participants received uninterrupted once daily oral 600 mg dose of bosutinib for at least 2 weeks in study B1871040.

Bosutinib 600 mg

The pharmacokinetic (PK) analysis set included participants who received at least 1 dose of bosutinib and had 1 reported bosutinib concentration.

Plasma Steady-State Trough Concentrations (Ctrough) of Bosutinib

The evaluable analysis set for cytogenetic population were those dosed participants from B1871006 with valid baseline efficacy assessment from B1871006 with \>=20 metaphases or at least 1 Ph+ metaphase from baseline bone marrow cytogenetic assessment and who achieved MCyR (responders). "N"=evaluable participants. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib CP1L" (participants from B1871008).

Kaplan-Meier Estimate of Probability of Maintaining Major Cytogenetic Response (MCyR) at Year 10: B1871006 Participants

The evaluable analysis set for cytogenetic population were those dosed participants from B1871006 with a valid baseline efficacy assessment from B1871006 with \>=20 metaphases or at least 1 Ph+ metaphase from the baseline bone marrow cytogenetic assessment and who achieved CCyR (responders). "N"=evaluable participants. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib CP1L" (participants from B1871008).

Kaplan-Meier Estimate of Probability of Maintaining Complete Cytogenetic Response (CCyR) at Year 10: B1871006 Participants

The evaluable analysis set for hematologic population were those dosed participants from B1871006 with a valid baseline efficacy assessment from B1871006 and a valid baseline hematologic assessment and who achieved CHR (responders). "N"=evaluable participants. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib CP1L" (participants from B1871008).

Kaplan-Meier Estimate of Probability of Maintaining Complete Hematologic Response (CHR) at Year 10: B1871006 Participants

The full analysis set from B1871006 included all dosed participants from the study B1871006. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib CP1L" (participants from B1871008).

Cumulative Incidence of Progression/Death Events at Year 10: B1871006 Participants

The full analysis set from B1871006 included all dosed participants from the study B1871006. Data for this outcome measure was planned to be collected and analyzed for participants from B1871006 only and not for reporting arm "Bosutinib, CP1L" (participants from B1871008). For "Bosutinib ADV" reporting arm, data was analyzed for participants with AP who had BP transformation only.

Cumulative Incidence of Rate of Transformation to Accelerated Phase (AP) or Blast Phase (BP) at Year 10: B1871006 Participants

Participants from B1871008 with Philadelphia chromosome-positive (Ph+) chronic phase 1st line (CP1L) chronic myeloid leukemia (CML) who either continued to receive the same bosutinib dose as at the time of completion of B1871008 or continued to be followed for survival. Dose for bosutinib was 500 milligram (mg) orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.

Participants from B1871006 with Ph+ chronic phase 2nd line (CP2L) CML who were resistant or intolerant to imatinib either continued to receive the same bosutinib dose as at the time of completion of B1871006 or continued to be followed for survival. Dose for bosutinib was 500 mg orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.

Participants from B1871006 with Ph+ chronic phase 3rd line (CP3L)/4th line (CP4L) CML who were resistant or intolerant to imatinib and resistant or intolerant to dasatinib and/or nilotinib either continued to receive the same bosutinib dose as at the time of completion of B1871006 or continued to be followed for survival. Dose for bosutinib was 500 mg orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.

Advanced (ADV) participants from B1871006 with Ph+ accelerated phase (AP), blast phase (BP) CML, Ph+ acute lymphoblastic leukemia (ALL) and resistant or intolerant to imatinib only or resistant or intolerant to imatinib and at least 1 additional tyrosine kinase inhibitor (TKI) including dasatinib and/or nilotinib who either continued to receive the same bosutinib dose as at the time of completion of B1871008 or continued to be followed for survival. Dose for bosutinib was 500 mg orally once daily (adjusted dose varied from 200 mg to 600 mg once daily). Treatment continued until the end of the study, disease progression, unacceptable toxicity, death, withdrawal of consent or study discontinuation whichever occurred first. Follow-up continued till end of the study or death due to any cause whichever occurred first. Participants remained in this study, either for treatment or for follow-up, until the last participant enrolled in 1 of the parent studies reached 10 years of follow-up, as calculated from the date of his/her first dose of bosutinib administered in parent study.

This group will be evaluated for marker presence in NAF. no drugs administered

This group will be evaluated to study whether marker(s) detected in NAF are also expressed in non-cancerous tumors. No drugs administered

In this group, any markers detected in NAF could also be detected in tumor tissues. No drugs administered.

This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically detectable tumors, and those who have detectable tumors, 2) identify all the detectable markers and 3) establish that biomarkers detected in NAF could also be detected in the biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable tumors.

Biomarker Breast Pap Test

Silbiotech

Principal Investigator

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Mesothelioma

Mesothelioma, Malignant

Carcinoma

Neoplasms, Glandular and Epithelial

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Adenoma

Neoplasms, Mesothelial

Ovarian Cancer

Ovarian Epithelial Cancer

Malignant Mesothelioma

CART-meso are autologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor SS1 fused to the 4-1BB and CD3ζ signaling domains.

CART-meso

Andrew Haas, MD

Phase I study to establish safety and feasibility of intravenously administered lentiviral transduced CART-meso cells administered with and without cyclophosphamide in a 3+3 dose escalation design in patients with metastatic pancreatic cancer, serous epithelial ovarian cancer, or pleural mesothelioma. Dose: 1-3xE7 /mE2 (Cohort 1 and 2) and 1-3xE8 /mE2 (Cohort 3 and 4 ) CAR+ T cells by intravenous route. In the event of 2 DLTs at each dose level, we will dose deescalate by 10-fold.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study to Extend the Maximum Maintenance Flushing Interval for Ports With Distally Valved Catheters	NCT01586026	Cancer		21 Years -	C. R. Bard
Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008	NCT01903733	Chronic Myeloid...	bosutinib	18 Years -	Pfizer
Bosutinib Treatment Extension Study Only For Subjects With Chronic Myeloid Leukemia (CML) Who Have Previously Participated In Bosutinib Studies B1871006 Or B1871008	NCT01903733	Chronic Myeloid...	bosutinib	18 Years -	Pfizer
Biomarker Breast Pap Test	NCT01683305	Tumors		18 Years -	Silbiotech
Biomarker Breast Pap Test	NCT01683305	Tumors		18 Years -	Silbiotech
CART-meso in Mesothelin Expressing Cancers	NCT02159716	Metastatic Panc... Epithelial Ovar... Malignant Epith...	CART-meso	18 Years -	University of Pennsylvania
CART-meso in Mesothelin Expressing Cancers	NCT02159716	Metastatic Panc... Epithelial Ovar... Malignant Epith...	CART-meso	18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for subjects

Every month we try and update this database with for subjects cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for subjects

Every month we try and update this database with for subjects cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for subjects cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.