Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Immune System Diseases

Rare Diseases

Adenocarcinoma

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Hypersensitivity

Fallopian Tube Neoplasms

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

Fallopian Tube Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Immunologic Factors

Monoclonal antibody hu3S193 will be administered to 51 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.

30 mg/m2 of Monoclonal antibody Hu3S193, IV as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.

Monoclonal antibody Hu3S193

Oren Smaletz, MD

RATIONALE: Monoclonal antibodies, such as Hu3S193, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well Hu3S193 works as a consolidation therapy for women with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tube cancer.

This is a phase II multicenter trial with Hu3S193 as a single agent in a consolidation strategy in patients with relapsing platinum-sensitive ovarian, primary peritoneal and fallopian tubes cancer who achieve a second Complete Response after a platinum-based chemotherapy after platinum-based chemotherapeutical regimen. Fifty-one (51) patients with relapsing platinum-sensitive ovarian, primary peritoneal or fallopian tubes adenocarcinoma will receive doses of 30 mg/m2 of Hu3S193 as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). After the treatment period, patients will be evaluated every 3 months for the first two years, and every 6 months for more 3 years, and then in an annual-basis until disease progression or death, whichever happens first.

Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

A Phase II Trial of Hu3S193 Consolidation Therapy for Patients With Relapsing Platinum-sensitive Ovarian, Primary Peritoneal and Fallopian Tubes Adenocarcinoma, Who Achieved a Second Complete Response

Recepta Biopharma understands the importance of individual-patient data (IPD) sharing and will include it in its future clinical studies; however, as this clinical study initiated in Apr-2011, an IPD was not planned.

PFS2 is defined by the interval from the beginning of rescue platinum-based chemotherapy until documented disease progression or death for any cause while the patient was under study or during the prolonged follow-up period.

Disease progression is defined by appearance of any new lesion (measurable and non-measurable) by the RECIST criteria. Disease progression date is the date when a new lesion is documented.

Overall survival was calculated as the time interval between the date of beginning of rescue platinum-based chemotherapy and date of death for any cause.

Vital signs were assessed throughout the study treatment (consolidation therapy).Through study completion, an average of 27 weeks.

Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.

Both parameters were assessed throughout the study treatment. Vital signs during the study treatment (consolidation therapy). Through study completion, an average of 27 weeks.

The Good Clinical Practice Guidelines define an Adverse Event as any untoward medical event that occurs in a patient or study patient receiving a pharmaceutical product, regardless of its causal relationship with the study treatment. Accordingly, an AE was considered as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or aggravated) temporally associated with the use of an investigational product.

The incidence of adverse events (percentage of patients with at least one adverse event and serious adverse events (overall and with reasonable relationship)) was assessed for the safety population

A SAE was defined as an AE that met one of the following conditions: Death during the protocol-defined surveillance period; Potentially fatal event (defined as a patient at immediate risk of death at the time of the event); An event requiring the patient's hospitalization or prolongation of an existing hospitalization during the protocol-defined surveillance period; An event resulting in congenital anomaly or birth defect; An event resulting in a persistent or significant disability/incapacity; Any other major medical event that did not result in death, was not life threatening, or did not require hospitalization, but that could be considered a SAE when, based on the appropriate medical judgment, it presented a risk for the patient and required medical or surgical intervention to prevent one of the outcomes listed above.

Cmax = Peak (postdosing) Hu3S193 plasma concentration. Cmin = Trough (predosing) Hu3S193 plasma concentration (Cmin). Plasma concentration of Hu3S193 expressed in μg/mL.

Recepta Biopharma

After the 30-day period, the investigator reported the adverse events that in his/her opinion were related to investigational product. In this study, AEs terms were coded using the Medical Dictionary for Regulatory Activities (MedDRA) at the Preferred Term (PT) and System Organ Class (SOC) levels.

hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks

hu3S193

Monoclonal Antibody hu3S193

Age, Continuous

# of Female patients is due to the inclusion criteria number #02: "Female patients of ≥18 years of age"

Gender

White

Black

Yellow

Brown

Other

Race/Ethnicity/Color was recorded at screening

Race/Ethnicity, Customized

Brazil

The clinical trial was performed only in Brazil

Region of Enrollment

A total of 37 patients were screened for this study of whom 29 were considered eligible and included in the study (baseline participants).

Director of Clinical Trials

In the ITT (intention to treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored. The median time to disease progression or death was 11.8 months (95% CI (confidence interval), 10.6 to 13.9 months).

1-year PFS2 Rate After the Beginning of Rescue Platinum-based Chemotherapy

In the ITT (Intention-to-treat) population, 25 patients out of the 29 considered for the PFS2 analysis presented disease progression or death and 4 were censored.

1-year Disease Progression-free Survival Rate

Within the ITT population, 7 patients died and 22 were censored. The 2-year overall survival rate was 70.7%.

Two-year Overall Survival Rate

Baseline

Week 2

Week 4

Week 27

hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.

All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14

Safety - Vital Signs - Heart Rate

Safety - Vital Signs - Respiratory Rate

Diastolic Baseline

Diastolic Week 2

Diastolic Week 4

Diastolic Week 27

Systolic Baseline

Systolic Week 2

Systolic Week 4

Systolic Week 27

All patients enrolled in this study received at least one dose of Hu3S193 (30 mg/m2) - ITT dataset. Diastolic Baseline n=29, week 2 n=27, week 4 n= 28, week 27 n= 14/ Systolic Baseline n=28, week 2 n=27, week 4 n= 28, week 27 n= 14

Safety - Vital Signs - Systolic and Diastolic Blood Pressure

Safety - Vital Signs - Temperature

Nausea

Vomiting

Abdominal pain

Constipation

Diarrhoea

Abdominal pain upper

Dry Mouth

Dyspepsia

Abdominal pain lower

Intestinal Obstruction

All patients who received at least one dose of investigational product were included in the safety dataset.

Incidence of Adverse Events (AEs) - Gastrointestinal Disorders

Influenza like illness

Fatigue

Pain

Pyrexia

Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions

Myalgia

Back pain

Pain in extremity

Arthralgia

Groin pain

Knee pain

Muscle tightness

Musculoskeletal pain

Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders

Drug Hypersensitivity

Incidence of Adverse Events (AEs) - Immune System Disorders

Headache

Paraesthesia

Peripheral sensory neuropathy

Tremor

hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks.

Incidence of Adverse Events (AEs) - Nervous System Disorders

Neutrophil count decreased

White blood cell count decreased

Incidence of Adverse Events (AEs) - Investigations

Cough

Productive Cough

Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders

Oral Herpes

Clostridium difficile colitis

Gastroenteritis

Tooth abscess

Incidence of Adverse Events (AEs) - Infections and Infestations; Gastrointestinal Disorders

Incidence of Adverse Events (AEs) - Blood and Lymphatic System Disorders (Anaemia)

Sinusitis

Respiratory tract infection

Tonsillitis

Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders

Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.

Anti-Lewis Y humanized monoclonal antibody designated "orphan drug" by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation.

Incidence of Adverse Events (AEs) - Psychiatric Disorders (Anxiety)

Hypertension

Hyperaemia

Hypotension

Incidence of Adverse Events (AEs) - Vascular Disorders

Incidence of Adverse Events (AEs) - Cardiac Disorders; General Disorders and Administration Site Conditions; Respiratory, Thoracic and Mediastinal Disorders (Chest Pain)

Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Musculoskeletal and Connective Tissue Disorders (Chills)

Erythema

Pruritus

Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders

Cerumen impaction

Ear pain

Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders

Incidence of Adverse Events (AEs) - Hepatobiliary Disorders; Injury, Poisoning and Procedural Complications (Hepatotoxicity)

Incidence of Adverse Events (AEs) - Immune System Disorders; General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Infusion Related Reaction)

Bronchospasm

Rhinitis allergic

Incidence of Adverse Events (AEs) - Immune System Disorders; Respiratory, Thoracic and Mediastinal Disorders

Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Nervous System Disorders (Spinal Pain)

Hip fracture

Upper limb fracture

Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; Injury, Poisoning and Procedural Complications

Incidence of Adverse Events (AEs) - Psychiatric Disorders (Depression)

Incidence of Adverse Events (AEs) - Renal and Urinary Disorders (Dysuria)

Incidence of Adverse Events (AEs) - Renal and Urinary Disorders; Infections and Infestations (Urinary Tract Infection)

Incidence of Adverse Events (AEs) - Reproductive System and Breast Disorders (Vulvovaginal Dryness)

Incidence of Adverse Events (AEs) - Respiratory, Thoracic and Mediastinal Disorders; Cardiac Disorders (Dyspnoea)

Excoriation

Injection site erythema

Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Injury, Poisoning and Procedural Complications

Incidence of Adverse Events (AEs) - Cardiac Disorders; Vascular Disorders; Nervous System Disorders (Dizziness)

Incidence of Adverse Events (AEs) - Ear and Labyrinth Disorders; Nervous System Disorders (Vertigo)

Incidence of Adverse Events (AEs) - Endocrine Disorders; Metabolism and Nutrition Disorders (Hyperglycaemia)

Incidence of Adverse Events (AEs) - Eye Disorders (Ocular Hyperaemia)

Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Pharyngitis)

Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Reproductive System and Breast Disorders; Renal and Urinary Disorders (Pelvic Pain)

Incidence of Adverse Events (AEs) - Gastrointestinal Disorders; Vascular Disorders (Anal Haemorrhage)

Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Hyperthermia)

Incidence of Adverse Events (AEs) - General Disorders and Administration Site Conditions; Injury, Poisoning and Procedural Complications (Catheter Site Inflammation)

Incidence of Adverse Events (AEs) - Immune System Disorders; Blood and Lymphatic System Disorders; Injury, Poisoning and Procedural Complications (Transfusion Reaction)

Incidence of Adverse Events (AEs) - Infections and Infestations; Respiratory, Thoracic and Mediastinal Disorders (Bronchitis)

Incidence of Adverse Events (AEs) - Infections and Infestations; Renal and Urinary Disorders (Urinary Tract Infection Bacterial)

Incidence of Adverse Events (AEs) - Investigations (Blood Cholesterol Increased)

Incidence of Adverse Events (AEs) - Musculoskeletal and Connective Tissue Disorders; General Disorders and Administration Site Conditions; Renal and Urinary Disorders (Flank Pain)

Incidence of Adverse Events (AEs) - Nervous System Disorders; Psychiatric Disorders; Respiratory, Thoracic and Mediastinal Disorders (Hoarseness)

Incidence of Adverse Events (AEs) - Psychiatric Disorders; Nervous System Disorders (Insomnia)

Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Infections and Infestations (Tinea Pedis)

Incidence of Adverse Events (AEs) - Skin and Subcutaneous Tissue Disorders; Reproductive System and Breast Disorders (Vulvovaginal Pruritus)

Incidence of Adverse Events (AEs) - Vascular Disorders; Gastrointestinal Disorders (Haemorrhoids)

Incidence of Adverse Events (AEs) - Vascular Disorders; Respiratory, Thoracic and Mediastinal Disorders (Epistaxis)

Intestinal obstruction

Incidence of Serious Adverse Events (SAEs) - Gastrointestinal Disorders

Incidence of Serious Adverse Events (SAEs) - Musculoskeletal and Connective Tissue Disorders - Hip Fracture

Cmin

Cmax

All patients enrolled in the study that received at least 9 doses of investigational product were considered to this analysis.

Pharmacokinetic

PK samples were analyzed from 10 patients. Dose: 30 mg/m2 every two weeks

Overall Mean Pharmacokinetic (PK) Data (Minimum and Maximum Concentrations)

Spots Global Cancer Trial Database for Consolidation Therapy With Hu3S193 for Women With Ovarian, Primary Peritoneal or Fallopian Tube Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial