Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Carcinoma

Ovarian Neoplasms

Carcinoma, Ovarian 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

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Bevacizumab

Carboplatin

Niraparib

Dostarlimab

Poly(ADP-ribose) Polymerase Inhibitors

Enzyme Inhibitors

Participants in this arm will receive SOC (carboplatin+paclitaxel+/-bevacizumab) in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment with dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/-bevacizumab along with niraparib placebo and dostarlimab placebo.

Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab placebo from cycles 2 to 6 and maintenance treatment of +/- bevacizumab with niraparib and dostarlimab placebo.

Participants in this arm will receive SOC in cycle 1 (each cycle is of 21 days) followed by SOC with chemotherapy treatment dostarlimab, and maintenance treatment of +/-bevacizumab with niraparib and dostarlimab.

Participants will receive oral capsules of niraparib as a unit dosage strength of 100 milligrams (mg).

Participants will receive 30 minutes intravenous (IV) infusions of 1000 mg dostarlimab on Day 1 every 6 weeks.

Dostarlimab (TSR-042)

Participants will receive SOC that includes paclitaxel 175 milligrams per square meter (mg/m\^2) on day 1 every 21 days + carboplatin area under the curve (AUC) of 5 to 6 milligrams per milliliter per minute (mg/mL/min) on day 1 every 21 days +/- bevacizumab 7.5 milligrams per kilograms (mg/kg) every 21 days or 15 mg/kg every 21 days for a total of 15 months.

Standard of care

Participants will receive 1000 mg of dostarlimab-placebo on day 1 every 6 weeks to continue up to 3 years in the absence of disease progression, unacceptable toxicity, participant withdrawal, or investigator decision

Dostarlimab-Placebo

Participants will receive oral capsules of niraparib-placebo as a unit dosage strength of 100 mg.

Niraparib-Placebo

GSK Clinical Trials

Ovarian cancer is a heterogeneous disease, characterized by complex molecular and genetic changes. The high expression of vascular endothelial growth factor (VEGF) receptor, programmed death receptor ligands 1 (PD-L1) expression, and deoxyribonucleic acid (DNA) damage in ovarian tumors provide several targets for treatment and maintenance of disease response. Given the unmet medical need of participants with advanced or metastatic ovarian cancer, this study design will enable investigators to provide participants with current SOC for ovarian cancer for the duration of the study. This is a global, multicenter, randomized, double-blind, controlled Phase 3 study that will primarily compare the progression-free survival (PFS) for participants receiving dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus participants receiving SOC with chemotherapy followed by niraparib maintenance. This comparison will be investigated both in the PD-L1 positive and overall population of newly diagnosed stage III or IV advanced non-mucinous epithelial ovarian cancer participants and also to compare PFS of all participants with Stage III or IV high-grade non-mucinous epithelial ovarian cancer treated with platinum-based combination therapy, dostarlimab (TSR-042), and niraparib to SOC platinum-based combination therapy. The currently recommended SOC therapy for the first line treatment of Stage III or IV ovarian cancer is the combination of paclitaxel and carboplatin, with or without concurrent and maintenance bevacizumab. Participants will receive SOC during the chemotherapy Run-In period (cycle 1) before randomization to study treatment (cycle 2). Concurrent bevacizumab use must be determined prior to randomization at cycle 2.

Female participants will be included in the study.

A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

A Randomized, Double-blind, Phase 3 Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer

To compare the PFS of PD-L1 positive participants with Stage III or IV non-mucinous epithelial ovarian cancer given first-line treatment with the combination of dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus SOC chemotherapy +/- bevacizumab followed by niraparib maintenance +/- bevacizumab. PFS is defined as the time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression. PFS will be evaluated by investigator assessment per Response Evaluation Criteria in Solid Tumors (RECIST) version (v.) 1.1 criteria.

To compare the PFS of all participants with Stage III or IV high-grade nonmucinous epithelial ovarian cancer given first-line treatment with the combination of dostarlimab with SOC chemotherapy +/- bevacizumab followed by niraparib and dostarlimab maintenance +/- bevacizumab versus SOC chemotherapy +/- bevacizumab followed by niraparib maintenance +/- bevacizumab. PFS is defined as the time from treatment randomization to the earlier date of assessment of progression or death by any cause in the absence of progression. PFS will be evaluated by investigator assessment per RECIST v.1.1 criteria.

BICR determined PFS will be assessed as per RECIST criteria.

OS is defined as the date of randomization to the date of death by any cause.

TEAEs are defined as, any event that was not present prior to the initiation of study treatment or any event already present that worsens in either intensity or frequency following exposure to study treatment.

SAEs are any adverse event that may result in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability or incapacity, is a congenital abnormality or birth defect, is an important medical event.

Adverse events are any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment.

Following events are categorized as irAEs: Diarrhea/colitis, aspartate aminotransferase (AST) or alanine aminotransferase (ALT; \>3 and \<=5 X upper limit of normal \[ULN\]), or increased bilirubin, type 1 diabetes mellitus (T1DM) or hyperglycemia, immune-related encephalitis, uveitis, myositis, hypophysitis, adrenal insufficiency, hypo- and hyperthyroidism, infusion-related reaction, pneumonitis, immune-related rash, renal failure or nephritis and recurrence of adverse events after resolution to Grade \<=1.

Following events are categorized as irAEs: Diarrhea/colitis, AST or ALT (\>3 and \<=5 X ULN), or increased bilirubin, T1DM or hyperglycemia, immune-related encephalitis, uveitis, myositis, hypophysitis, adrenal insufficiency, hypo- and hyperthyroidism, infusion-related reaction, pneumonitis, immune-related rash, renal failure or nephritis and recurrence of AEs after resolution to Grade \<=1.

Performance status will be assessed using the ECOG performance status scale: ranging from Grade 0 to 5, Grade 0 denoting fully active and Grade 5 denoting death.

Blood samples will be collected for the analysis of hematologic parameters including: hemoglobin, platelet count, white blood cell count, differential white blood cell count, coagulation factors-International normalized ratio (INR) and activated partial thromboplastin time.

Blood samples will be collected for the analysis of hematologic parameters including: hemoglobin, platelet count, white blood cell count, differential white blood cell count, coagulation factors-INR and activated partial thromboplastin time.

Blood samples will be collected for the analysis of clinical chemistry parameters including: amylase, thyroid function (thyroid stimulating hormone \[TSH\]), urea or blood urea nitrogen, creatinine, albumin, total protein, ALT, AST, total bilirubin, Glucose, Magnesium, Calcium, Chloride, Potassium and Sodium.

Blood samples will be collected for the analysis of clinical chemistry parameters including: amylase, thyroid function (TSH), urea or blood urea nitrogen, creatinine, albumin, total protein, ALT, AST, total bilirubin, Glucose, Magnesium, Calcium, Chloride, Potassium and Sodium.

EQ-5D-5L is a validated questionnaire to assess the overall health-related quality of life in participants across diseases. EQ-5D-5L consists of a descriptive section of 5 questions/dimensions, one related to each of: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is measured by 5-point Likert scale (no problems, slight problems, moderate problems, severe problems and extreme problems).

EORTC QLQ-C30 is a validated questionnaire to assess the overall health-related quality of life in participants with cancer and is composed of 30 questions including multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/quality of life scale (GHS/QOL), and six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). Response options are 1 to 4. Higher score indicates better health-related quality of life.

EORTC QLQ-C30 is a validated questionnaire to assess the overall health-related quality of life in participants with cancer and is composed of 30 questions including multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL, and six single items (dyspnoea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Response options are 1 to 4. Higher score indicates better health-related quality of life.

EORTC QLQ-OV28 is a validated questionnaire to assess the overall health-related quality of life in participants with local or advanced ovarian cancer. EORTC QLQ-OV28 consists of 28 questions evaluated across eight multi-item and 4 single item scales: abdominal/ gastrointestinal (GI) symptoms, peripheral neuropathy, hormonal symptoms, body image, attitude to disease/treatment, chemotherapy side effects, and sexuality, and single items scales for indigestion/heartburn, hair loss, upset due to hair loss, and taste. All questions are rated on a 4 point verbal rating scale: "Not at all," "A little," "Quite a bit," and "Very much."

EORTC QLQ-OV28 is a validated questionnaire to assess the overall health-related quality of life in all the participants with local or advanced ovarian cancer. EORTC QLQ-OV28 consists of 28 questions evaluated across eight multi-item and 4 single item scales: abdominal/GI symptoms, peripheral neuropathy, hormonal symptoms, body image, attitude to disease/treatment, chemotherapy side effects, and sexuality, and single items scales for indigestion/heartburn, hair loss, upset due to hair loss, and taste. All questions are rated on a 4 point verbal rating scale: "Not at all," "A little," "Quite a bit," and "Very much."

EORTC QLQ-C30 is a validated questionnaire to assess the overall health-related quality of life in participants with cancer and is composed of 30 questions including multi-item scales and single item measures. These include five functional scales (physical, role, emotional, cognitive and social), three symptom scales (fatigue, nausea/vomiting, and pain), a GHS/QOL, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Response options are 1 to 4. Higher score indicates better health-related quality of life.

EORTC QLQ-OV28 is a validated questionnaire to assess the overall he PFS2, health-related quality of life in participants with local or advanced ovarian cancer. EORTC QLQ-OV28 consists of 28 questions evaluated across eight multi-item and 4 single item scales: abdominal/GI symptoms, peripheral neuropathy, hormonal symptoms, body image, attitude to disease/treatment, chemotherapy side effects, and sexuality, and single items scales for indigestion/heartburn, hair loss, upset due to hair loss, and taste. All questions are rated on a 4 point verbal rating scale: "Not at all," "A little," "Quite a bit," and "Very much."

TFST is defined as the time from randomization until the start date of the first subsequent anti-cancer therapy or death, whichever occurs first.

TSST is defined as the time from randomization until the start date of the second subsequent anti-cancer therapy or death, whichever occurs first.

PFS2 is defined as the time from randomization until PD per investigator's assessment after starting follow-up anti-cancer therapy or death due to any cause, whichever occurs first.

ORR, defined as the percentage of participants with complete response (CR) or partial response (PR) on study treatment as assessed by RECIST v.1.1 criteria for participants with measurable disease.

pCR rate, per investigator assessment, defined as the rate of pathologic complete responseas assessed by the evaluation of residual microscopic disease at the time of surgery in neoadjuvant participants.

DOR, defined as the time from first documentation of CR or PR until the time of first documentation of PD as assessed by RECIST v.1.1, or death by any cause in the absence of progression, whichever occurs first.

DCR, defined as the proportion of participants with a best overall response of CR, PR, or stable disease (SD), as assessed by RECIST v.1.1 criteria.

DCR, defined as the proportion of participants with a best overall response of CR, PR, or SD, as assessed by RECIST v.1.1 criteria.

MPFS, defined as the time from the date of the first maintenance period dose to the date of first documentation of progression or death by any cause in the absence of progression, whichever occurs first, as determined by the investigator. Progression will be assessed by RECIST v.1.1 criteria.

Blood samples will be collected for pharmacokinetic analysis of dostarlimab.

Serum samples will be collected for the analysis of the presence of ADAs using validated immunoassays.

Blood samples will be collected for pharmacokinetic analysis of niraparib.

European Network of Gynaecological Oncological Trial Groups (ENGOT)

Tesaro, Inc.

Blood and Lymph Conditions

Symptoms and General Pathology

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Recurrence

Hematologic Diseases

Disease Attributes

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Cytarabine

Daunorubicin

First induction: 100 units/m2 on Days 1, 3, and 5 by 90-minute IV infusion Second induction: 100 units/m2 on Days 1 and 3 by 90-minute IV infusion Consolidation(s): 100 units/m2 on Days 1 and 3 by 90-minute IV infusion

First induction: Investigator's choice salvage therapy administered according to local practice Second induction: Investigator's choice salvage therapy administered according to local practice Consolidation(s): Investigator's choice consolidation therapy administered according to local practice

CPX-351

Intensive Salvage Therapy

Jonathan Kolitz, MD

The study investigates if CPX-351 will be a) more effective than the standard intensive salvage AML treatment and b) more tolerable than the standard intensive salvage treatment regimens.

The study compares the investigational product CPX-351 vs the standard intensive salvage treatment for first relapse AML patients.

This study is a randomized, open-label, parallel-arm, fixed-dose, standard therapy controlled Phase IIB trial. Study enrollment duration is expected to be approximately 12-18 months. On entry, patients are randomized to receive either CPX-351 or intensive first salvage treatment.

Patients are stratified to balance the likelihood of obtaining a CR and the duration of CR between the two arms.

Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)

Phase IIB, Multicenter, Randomized, Open-Label Trial Of CPX-351 (Cytarabine : Daunorubicin) Liposome Injection Versus Intensive Salvage Therapy In Adult Patients ≤ 65 Years Old With AML In First Relapse Following An Initial CR > 1 Month Duration

The proportion of subjects surviving at 1 year was evaluated separately for each arm by the number of subjects alive at 1 year divided by the total number of subjects.

Remission duration was measured from the time the criteria for CR were first met until the first date that disease relapse was objectively documented or until subject death.

Number of patients transferred for stem cell transplant

The Leukemia and Lymphoma Society

Jazz Pharmaceuticals

Safety Population: All randomized participants who received at least one dose of study medication.

Salvage Therapy

Total

Age, Continuous

Sex: Female, Male

Safety Analysis Set

One subject in the Salvage Therapy arm was randomized and withdrew consent prior to treatment, and therefore was excluded from the analysis

Associate Director, Clinical Trial Disclosure & Transparency

Efficacy Evaluable Analysis Set - All randomized participants who received at least one dose of study medication.

Proportion of Subjects Surviving at 1 Year

Efficacy Evaluable Analysis Set: All randomized participants who received at least one dose of study medication.

Complete Remission Rate

Event Free Survival

Remission Duration

Rate of Aplasia

Rate of Stem Cell Transplant

Overall Study

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Hormones

Fulvestrant

Estrogens

Anastrozole

Antineoplastic Agents, Hormonal

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormone Antagonists

Aromatase Inhibitors

intramuscular injection 250 mg loading dose (LD) regimen

Roger Henriksson, MD

The purpose of this study is to determine the efficacy of anastrozole monotherapy versus maximal oestrogen blockade with combinated therapy of fulvestrant and anastrozole compared with in treatment of hormone receptor positive women with first relapse of breast cancer.

Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy

FACT: Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy; an Open Randomized, Comparative, Phase III Multicentre Study in Postmenopausal Women With Hormone Receptor Positive Breast Cancer in First Relapse After Primary Treatment of Localized Tumor.

RECIST (Response Evaluation Criteria in Solid Tumours) assessments carried out every 8 weeks from randomisation until data cut-off on 30th April 2009. TTP, time in months to worsen 'progression' according to RECIST criteria. (RECIST is a set of published rules that define when cancer patients improve "respond", stay the same "stable"or worsen "progression" during treatments.

No. of patients who were objective responders over the no. of patients evaluable for response x100. An objective responder = a patient whose best response is either CR (disappearance of all lesions) or PR (\>= 30% shrinkage in the sum of the longest diamemeters of the measurable lesions + no new lesions + no progression of non-measurable lesions)

No. of patients who were clinical benefit responders over the no. of randomised patients x100. A clinical benefit responder = a patient whose best response is CR, PR or SD\>=24 weeks (where a best response of SD = no new lesions and for existing lesions; neither suffient shrinkage to count as PR nor sufficient growth to count as progression)

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are objective responders

Median time from randomisation until objective progression or death (in the absence of objective progression), measured only in those patients who are clinical benefit responders

Time from randomisation until the date of discontinuation of randomised treatment for any reason

Overall survival is equivalent to time to death. Time from randomisation until the date of death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Comparison of Platinum-based Therapy With TSR-042 and Niraparib Versus Standard of Care (SOC) Platinum-based Therapy as First-line Treatment of Stage III or IV Nonmucinous Epithelial Ovarian Cancer	NCT03602859	Ovarian Neoplas... Ovarian, Fallop...	Niraparib Dostarlimab (TS... Standard of car... Dostarlimab-Pla... Niraparib-Place...	18 Years -	Tesaro, Inc.
Trial of CPX-351 in Adult Patients With First Relapse Acute Myeloid Leukemia (AML)	NCT00822094	Acute Myeloid L...	CPX-351 Intensive Salva...	18 Years - 65 Years	Jazz Pharmaceuticals
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy	NCT00256698	Breast Cancer	Fulvestrant Anastrozole	-	AstraZeneca
Anastrozole Monotherapy Versus Maximal Oestrogen Blockade With Anastrozole and Fulvestrant Combination Therapy	NCT00256698	Breast Cancer	Fulvestrant Anastrozole	-	AstraZeneca

Spots Global Cancer Trial Database for first

Every month we try and update this database with for first 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 first

Every month we try and update this database with for first 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 first 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.