Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Thrombosis

Venous Thrombosis

Hemorrhage

Pulmonary Embolism

Embolism

Thromboembolism

Venous Thromboembolism

Embolism and Thrombosis

Vascular Diseases

Lung Diseases

Respiratory Tract Diseases

Anticoagulants

All Drugs and Chemicals

Fibrinolytic Agents

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Heparin

Calcium heparin

Abelacimab intravenous administration followed by monthly administration of the same dose subcutaneously

Dalteparin administered subcutaneously daily

Abelacimab

Dalteparin 200 IU/kg/day followed by 150 IU/kg/day

Nancy Widener

Deb Freedholm

This is a Phase 3, multicenter, open-label, blinded endpoint study to evaluate the effect of abelacimab relative to dalteparin on venous thromboembolism (VTE) recurrence and bleeding in patients with gastrointestinal (GI)/genitourinary (GU) cancer associated VTE (Magnolia)

Cancer associated thrombosis (CAT) is a severe medical condition which is characterized by high incidence of Venous thromboembolism (VTE) recurrence and high risk for bleeding. Patients with intact GI and GU cancer have increased bleeding risk with oral direct anticoagulants (DOACs), Guidelines advice caution with those DOACs or state preference for low molecular weight heparin (LMWH) in this population. The ANT-008 study will compare treatment with abelacimab monthly administration to LMWH daily subcutaneous (sc) administration over 6-month treatment. The study outcomes include VTE recurrence, bleeding event and treatment discontinuation at 6 months

A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE

A Multicenter, Randomized, Open-label, Blinded Endpoint Evaluation, Phase 3 Study Comparing the Effect of Abelacimab vs. Dalteparin on Venous Thromboembolism (VTE) Recurrence and Bleeding in Patients With GI/GU Associated VTE

Itreas

Anthos Therapeutics, Inc.

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antineoplastic Agents

Apaziquone

6 weekly multi-instillation of Apaziquone 4 mg in 40 mL

6 weekly multi-instillation of matching placebo in 40mL

Placebo

Show-Li Sun, MD

This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.

Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)

A Phase 3 International, Double-Bind Trial Evaluating Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

Time from randomization to the date of first histologically confirmed recurrence of bladder cancer

Proportion of patients with recurrence at or before 24 months

Allergan

Spectrum Pharmaceuticals, Inc

6 weekly multi-instillation of matching placebo in 40 mL

Open Label-Apaziquone

Apaziquone (4 mg in 40 mL)

Apaziquone: 6 weekly multi-instillation of Apaziquone 4 mg in 40 mL

Matching placebo (40 mL)

Placebo: 6 weekly multi-instillation of matching placebo in 40mL

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Gajanan Bhat, PhD

Patients who were in the Double Blind Phase

Time to Recurrence

2-Year Recurrence Rate

Open Label Phase

Double Blind Phase

This is an international, multicenter, double-blind, placebo-controlled, randomized study. All eligible patients entering the open label phase of the study will receive a single immediate instillation of apaziquone (4 mg in 40 mL diluent), post transurethral resection-bladder tumor (TURBT). Following Central Pathology review of histology and Double Blind Phase qualification, patients with confirmed eligibility will be randomized to receive either 6 weekly intravesical instillations of apaziquone or matching placebo and undergo cystoscopic and safety assessments every 3 months for 24 months from randomization. Patients with histologic evidence of recurrent disease during the study will be treated according to current treatment guidelines or local standard of care. Safety and efficacy assessments will be performed at 3 month intervals for all randomized patients throughout the study. Patients who receive single dose of apaziquone immediately following TURBT and are not eligible for randomization will be followed for 3 months by cystoscopic exam and safety assessments.

Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer

A Phase 3 International, Multicenter, Double-Blind, Placebo-Controlled, Randomized Trial Evaluating the Efficacy and Safety of Multiple Instillations of Intravesical Apaziquone vs. Placebo in Patients With Low-Intermediate Risk Non-Muscle Invasive Bladder Cancer (NMIBC)

Time to recurrence is the time from randomization to the date of first histologically confirmed recurrence of bladder cancer (for eligible patients with Low- intermediate risk NMIBC, who had undergone TURBT followed by, a single instillation of apaziquone immediately post TURBT and multiple instillations of apaziquone or placebo).

Measurement the number of participants with the recurrence at 24 months.

TEAEs will be mainly characterized by the number of treatment emergent adverse events and treatment related AEs that occur or worsen after the first dose of study treatment.

Apaziquone: Apaziquone 4 mg in 40 mL diluent

Apaziquone: Apaziquone in the Double Blind Phase

Placebo

Placebo: Placebo in the Double Blind Phase

Apaziquone 4 mg in 40 mL diluent

Apaziquone in the Double Blind Phase

Placebo

Placebo in the Double Blind Phase

Gender

Safety Analysis Population included all randomized patients in the double blind phase.

Gajanan Bhat

Apaziquone: Apaziquone 4 mg in 40 mL diluent

Apaziquone in the Double Blind Phase

All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase. Participants without recurrence were censored.

All patients who received Apaziquone in the Open Label Phase and subsequently randomized to one of the treatment arms in the Double Blind Phase.

Recurrence Rate at 24 Months

Participants With Treatment Emergent Adverse Events (TEAEs)

Open Label Phase Apaziquone

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Lymphoma

Lymphosarcoma

Gastrointestinal Agents

Herbal and Botanical

Pancrelipase

Pancreatin

Cola

Doctors specializing in treating gastrointestinal cancer (cancer of the stomach, pancreas, colon, etc.), genitourinary cancer (cancer of the genitals and urinary tract), and lymphoma (cancer affecting the blood and lymph nodes)

Family members or caregivers of the patients in group 2

Health Care Professional's self-efficacy will be assessed by 12 ratings of self-reported confidence from (1) "strongly disagree" to (5) "strongly agree" in module-specific topics both before and after the training.

Self-Efficacy Assessment

The UCLA Geriatrics Attitudes Scale is a 14-item scale developed to assess health care providers' attitudes toward older persons and caring for older patients.

UCLA Geriatrics Attitudes Scale

The evaluation surveys for each of the three modules will contain fifteen statements assessing post-training attitudes regarding the skills learned and application of skills in oncology clinical practice, measured on a 5-point Likert scale.

Course Evaluations

The Consultation and Relational Empathy (CARE) questionnaire is a 10-item self-report scale that measures a patient's satisfaction with how empathic their health care providers (HCP) was within a specific consultation.

The Consultation and Relational Empathy (CARE) questionnaire

Patients" perceptions of the quality of their interactions with their clinicians will be rated with 6 items from the Consumer Assessment of Health Care Providers and Systems Program (CAHPS)

Consumer Assessment of Health Care Providers and Systems Program (CAHPS)

The PAM scale contains 22 items that assess patient engagement in their care process.

Patient activation measure (PAM) scale

Smita Banerjee, PhD

The purpose of this study is to learn more about the effects of a training program designed to help doctors communicate better with older patients and their caregivers.

Geriatric Communication Skills Training Program for Oncology Clinicians

Geriatric Communication Skills Training Program for Oncology Clinicians to Improve Management of Care for Geriatrics Cancer Patients

Measured by number of HCP successfully recruited for the training

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE	NCT05171075	Venous Thromboe... Deep Venous Thr... Pulmonary Embol...	Abelacimab Dalteparin	18 Years -	Anthos Therapeutics, Inc.
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)	NCT01469221	Bladder Cancer	Apaziquone Placebo	18 Years -	Spectrum Pharmaceuticals, Inc
Efficacy and Safety Study of Apaziquone vs. Placebo in Patients With Non-Muscle Invasive Bladder Cancer (NMIBC)	NCT01469221	Bladder Cancer	Apaziquone Placebo	18 Years -	Spectrum Pharmaceuticals, Inc
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer	NCT01410565	Bladder Cancer	Apaziquone Placebo	18 Years -	Spectrum Pharmaceuticals, Inc
Efficacy and Safety of Multi-Instillations of Apaziquone in Patients With Non-Muscle Invasive Bladder Cancer	NCT01410565	Bladder Cancer	Apaziquone Placebo	18 Years -	Spectrum Pharmaceuticals, Inc
Geriatric Communication Skills Training Program for Oncology Clinicians	NCT03530969	GI Cancer Lymphoma GU Cancer Bone Marrow Tra...	Self-Efficacy A... UCLA Geriatrics... Course Evaluati... The Consultatio... Consumer Assess... Patient activat...	18 Years -	Memorial Sloan Kettering Cancer Center
A Study Comparing Abelacimab to Dalteparin in the Treatment of Gastrointestinal/Genitourinary Cancer and Associated VTE	NCT05171075	Venous Thromboe... Deep Venous Thr... Pulmonary Embol...	Abelacimab Dalteparin	18 Years -	Anthos Therapeutics, Inc.

Spots Global Cancer Trial Database for gu cancer

Every month we try and update this database with for gu cancer 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 gu cancer

Every month we try and update this database with for gu cancer 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 gu cancer 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.