Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Recurrence

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Dexamethasone

Dexamethasone acetate

Trabectedin

Alkylating Agents

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Antineoplastic Agents, Alkylating

Trabectedin 1.3 mg/m2 administered intravenously every 21 days. Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose.

Trabectedin 1.3 mg/m2 administered intravenously every 21 days.

Dexamethasone 4 mg administered orally (by mouth) the day before the trabectedin dose, 30 minutes before the trabectedin dose, and for 2 days following the trabectedin dose

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

The purpose of this is to test the safety and effectiveness of an investigational chemotherapy agent in patients with persistent or recurrent endometrial cancer.

Patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. They will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the Investigator conducting this study. Trabectedin 1.3 mg/m2 will be given every 21 days to patients intravenously (i.v). over a 3-hour period via a central venous catheter (referred to as a "central line") which is a tube (ie, catheter) placed into a large vein that is used to administer medications. Dexamethasone 4 mg will be given orally (p.o.) the day before trabectedin and dexamethasone 20 mg will be given i.v. 30 minutes before trabectedin. Dexamethasone 4 mg p.o. will be given for 2 days following trabectedin administration.

Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma

A Phase 2 Study of ET-743 as Second-Line Therapy in Subjects With Persistent or Recurrent Endometrial Carcinoma

PharmaMar

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Skin and Connective Tissue Diseases

Skin Diseases

Breast Neoplasms

Breast Diseases

ET743 580 mcg/m2 3-hour i.v. infusion on Days 1 8 and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.

ET743 1 300 mcg/m2 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone 10 mg i.v will be administered 30 minutes prior to each trabectedin infusion.

580 mcg/m2, 3-hour i.v. infusion, on Days 1, 8, and 15 every 28 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.

ET743

1,300 mcg/m2, 3 hour i.v. infusion once every 21 days for up to approximately 52 weeks in the absence of disease progression. Dexamethasone, 10 mg i.v, will be administered 30 minutes prior to each trabectedin infusion.

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced breast cancer.

Patients will be enrolled in the study after all study specific-entry criteria are met and informed consent is obtained. Patients will be required to attend regular clinic visits to receive study medication and have their status monitored. Patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Trabectedin 580 mcg/m2 once weekly for 3 consecutive weeks (Treatment A) or 1,300 mcg/m2 once every 21 days (Treatment B) will be given to patients as a 3-hour intravenous (i.v). infusion via a central venous catheter which is a tube placed into a large vein that is used to administer medications. All patients will be given dexamethasone 10 mg i.v. 30 minutes before each trabectedin infusion. Patients may receive multiple cycles of trabectedin in the absence of disease progression.

A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer

A Phase 2 Study of ET-743 in Subjects With Advanced Breast Cancer

Sr Dir Clinical Research

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Sarcoma

Ovarian Cancer

Soft Tissue Sarcoma

3-hour placebo intravenous infusion on Day 1 and trabectedin 1.3 mg/m2 3-hour intravenous infusion on Day 2 (single-blind). Patients may continue treatment with trabectedin until clinical benefit or drug is commercially available (open-label).

Trabectedin will be administered as 1.3 mg/m2 3-hour intravenous infusion on Day 2.

Participants will receive 3-hour placebo intravenous infusion on Day 1.

Placebo

The purpose of this study is to assess the potential effects of trabectedin on the QT/QTc interval duration measured by electrocardiograms (ECGs) in participants with advanced solid tumor malignancies when administered at a therapeutic dose.

This is a single-blind (where the participant does not know the treatment he receives), multicenter (study conducted at multiple sites), placebo-controlled (an inactive substance that is compared with the study medication to test whether the study medication has a real effect in clinical study), sequential design (it is a design in a single group of Participants where one or more study medication is administered in a sequence) study to evaluate the potential effects of a single-dose administration of trabectedin on the QT intervals of the electrocardiogram (ECG). Initially, the study will consist of 2 phases: a screening phase (within 21 days before administration of the study medication), and a single-blind treatment phase (for 2 days). Participants who complete the single-blind treatment phase will be opted to take trabectedin in an open-label extension (for a minimum of 6 cycles), as long as they derive a clinical benefit (ie, until there is clear evidence of disease progression or unacceptable toxicity, as judged by the investigator). Participants will be assessed for ECG on predose before the single-blind treatment phase. During the single-blind treatment phase, a placebo control will be given on Day 1, and trabectedin (1.3 mg per square meter) will be administered on Day 2. Participants will be monitored until completion of the 24 hour pharmacokinetic blood sample collection. During the open-label extension (21 days after completion of the single-blind treatment phase), all Participants will receive trabectedin intravenously on Day 1 of each 17- to 49 day treatment cycle. The dose and schedule of trabectedin will be modified according to the type of malignancy being treated (ie, sarcoma, ovarian, or breast cancer). Safety evaluations will include assessment of adverse events, vital signs, physical examination, and clinical laboratory tests which will be performed throughout the study. The study duration for the open-label extension will vary by participant.

A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

A Single-Blind, Multicenter, Placebo-Controlled, Sequential Design Study Evaluating the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram

QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Fridericia correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.

QTc interval was measured by electrocardiograms to evaluate the potential effect of trabectedin on QTc interval duration. The Bazett's Correction was used as the standard clinical correction for calculating the heart rate-corrected QT interval.

The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QT interval.

The Fridericia (QTcF) and Bazett's (QTcB) correction were used as the standard clinical correction for calculating the heart rate-corrected QTc interval.

PR interval is the portion of the electrocardiogram between the onset of the P wave (atrial depolarization) and the QRS complex (ventricular depolarization).

QRS interval is the interval from the beginning of the Q wave to the termination of the S wave, representing the time for ventricular depolarization.

Adverse events were reported for overall study.

1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2

Age, Continuous

Sex: Female, Male

White

Asian

Other

Race/Ethnicity, Customized

Belgium

France

India

Republic Of Korea

Russia

Spain

United States Of America

Region of Enrollment

Senior Medical Director

Placebo: Normal saline was administered as a 3-hour intravenous infusion on Day 1.

1.3 mg/m2 of trabectedin was administered as a 3-hour intravenous infusion on Day 2.

All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order (trabectedin and placebo were given on Days 1 and 2, respectively) was excluded from evaluations.

The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Fridericia Correction

Maximum Plasma Concentration of Trabectedin (Cmax)

Time Taken to Acheive Maximum Plasma Concentration (Tmax)

QTcF greater than 30 milliseconds

QTcB greater than 30 milliseconds

Normal saline was administered as a 3-hour intravenous infusion on Day 1

Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 30 Milli Seconds

QTcF greater than 60 milliseconds

QTcB greater than 60 milliseconds

Number of Participants With QTc Interval Increase From Baseline (Predose on Day 1) Greater Than 60 Milli Seconds

QTcF greater than 450 milliseconds

QTcB greater than 450 milliseconds

Number of Participants With QTc Interval Greater Than 450 Milli Seconds

QTcF greater than 480 milli seconds

QTcB greater than 480 milli seconds

Number of Participants With QTc Interval Greater Than 480 Milli Seconds

QTcF greater than 500 milli seconds

QTcB greater than 500 milli seconds

Number of Participants With QTc Interval Greater Than 500 Milli Seconds

Number of Participants With PR Interval Greater Than 200 Milli Seconds

Number of Participants With QRS Interval Greater Than 120 Milli Seconds

All evaluable participants set: All participants who received placebo on Day 1 and trabectedin on Day 2 with atleast 1 paired predose and 1 paired postdose assessments. One participant who received study medication in reverse order was excluded from evaluations. 73 participants analyzed in trabectedin group to derive the mean.

Mean Heart Rate (Beats Per Minute) Over 24 Hours Postdose

Normal saline was administered as a 3-hour intravenous infusion on Day 1.

The Difference in the Change From Baseline (Predose on Day 1) in QTc Intervals Trabectedin Relative to Placebo at 24 Hour Post Dose by Bazett's Correction

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma	NCT00050440	Endometrial Neo... Uterine Neoplas... Genital Neoplas...	Trabectedin Dexamethasone	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Study of ET-743 (Trabectedin) in Patients With Advanced Breast Cancer	NCT00050427	Breast Neoplasm... Neoplasms Neoplasms by Si... Breast Diseases Skin Diseases	ET743 ET743	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram	NCT00786838	Solid Tumor	Trabectedin Placebo	18 Years - 65 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Study to Assess the Potential Effects of a Single-Dose Administration of Trabectedin on the QT Intervals of the Electrocardiogram	NCT00786838	Solid Tumor	Trabectedin Placebo	18 Years - 65 Years	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Phase 2 Study of ET-743 (Trabectedin) in Patients With Persistent or Recurrent Endometrial Carcinoma	NCT00050440	Endometrial Neo... Uterine Neoplas... Genital Neoplas...	Trabectedin Dexamethasone	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Spots Global Cancer Trial Database for et743

Every month we try and update this database with for et743 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 et743

Every month we try and update this database with for et743 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 et743 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.