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.

Blood and Lymph Conditions

Rare Diseases

Sarcoma

Neutropenia

Neoplasms, Connective and Soft Tissue

Soft Tissue Sarcoma

Granulocytopenia

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Lenograstim

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Doxorubicin (50 to 75 mg/m2) administered intravenously on Day 1 followed by trabectedin (0.9 to 1.3 mg/m2) administered intravenously on Day 1 every 3 weeks for up to 6 cycles. Dexamethasone 20 mg administered intravenously will be given within 1 hour before the start of doxorubicin. Patients may receive filgrastim for unmanageable neutropenia.

Doxorubicin 50 to 75 mg/m2 administered intravenously on Day 1

Trabectedin 0.9 to 1.3 mg/m2 administered intravenously on Day 1 every 3 weeks for up to 6 cycles

Dexamethasone 20 mg administered intravenously within 1 hour before the start of doxorubicin

Johnson & Johnson Pharmaceutical Research and Development, LLC Clinical Trial

The purpose of the study is to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which neutropenia (low white blood cell counts) could be managed with filgrastim (a Granulocyte-Colony Stimulation Factor that is used to help control neutropenia) in patients with a type of cancer called soft tissue sarcoma.

This is a multicenter, open-label (identity of the assigned study treatments will be known to patients and study staff) study to determine the dose of the combination of trabectedin (Yondelis) and Doxorubicin for which the neutropenia (low white blood cell counts) is manageable with the use of filgrastim (an agent used to manage neutropenia) and associated with clinically acceptable number of side effects severe enough to continuation of treatment in patients with recurrent or persistent soft tissue sarcoma (STS, a malignant tumor that attacks the body's infrastructure of fat, muscles, nerves, joints, blood vessels, or deep skin tissues). 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. A detailed explanation can be provided by the study physician (Investigator) conducting this study. Doxorubicin (50 to 75 mg/m2) will be given as a 10-15 minute intravenous (i.v.) infusion on Day 1 via a central venous catheter which is a tube placed into a large vein. Trabectedin (0.9 to 1.3 mg/m2) will be given as a 3 hour i.v. infusion, immediately following the administration of doxorubicin. Dexamethasone 20 mg will be given within 1 hour before the start of each doxorubicin i.v. infusion and filgrastim will be administered according to manufacturer's instructions.

A Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma

A Phase I Study to Determine the Dose of the Combination of Yondelis and Doxorubicin for Which Neutropenia is Manageable With the Support of Granulocyte-Colony Stimulation Factor in Subjects With Recurrent or Persistent Soft Tissue Sarcoma

PharmaMar S.A.U.

ECTEINASCIDIN 743

Sylvain Baruchel, MD

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Ecteinascidin 743 may be an effective treatment for solid tumors.

PURPOSE: Phase I trial to study the effectiveness of ecteinascidin 743 in treating children who have refractory solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose and dose-limiting toxicity of ecteinascidin 743 in pediatric patients with refractory solid tumors. II. Determine the pharmacokinetics of this drug in these patients. III. Determine the antitumor activity of this drug in this patient population.

OUTLINE: This is a dose escalation, multicenter study. Patients are stratified according to pretreatment (pretreated vs less heavily pretreated). Patients receive ecteinascidin 743 IV over 3 hours on day 1. Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of ecteinascidin 743 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicities.

PROJECTED ACCRUAL: A total of 3-20 patients will be accrued for this study within 2 years.

Ecteinascidin 743 in Treating Children With Refractory Solid Tumors

Phase I Study of ET-743 in Pediatric Refractory Solid Tumors

To determine the maximum tolerated dose (MTD) of vincristine, when used in combination with irinotecan, and the dose-limiting toxicity (DLT) of this combination; irinotecan will be administered IV over 1 hour x 5 days, q 21 days, with vincristine IVP days 1, 8, 15, 22, 29, every 42 days, to children with refractory solid tumors.

To determine a safe and tolerable dose of vincristine, when administered with irinotecan, for future evaluation in phase II clinical trials.

To determine the pharmacokinetics of vincristine and irinotecan (and its active metabolite SN-38) when administered in combination to children with refractory cancer.

To determine the incidence and severity of other toxicities of this combination.

To seek preliminary evidence of anti-tumor activity of irinotecan plus vincristine against recurrent solid tumors.

National Cancer Institute (NCI)

Children's Oncology Group

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Breast Neoplasms

Ovarian Neoplasms

Ovarian Cancer

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 Safety Study Utilizing Yondelis and Doxorubicin in Patients With a Type of Cancer Called Soft Tissue Sarcoma	NCT00102609	Soft Tissue Sar... Sarcoma Neoplasms, Conn... Neoplasms by Hi... Neoplasms	Doxorubicin Trabectedin Dexamethasone	18 Years -	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Ecteinascidin 743 in Treating Children With Refractory Solid Tumors	NCT00006463	Unspecified Chi...	ECTEINASCIDIN 7...	1 Year - 17 Years	Children's Oncology Group
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.
Ecteinascidin 743 in Treating Children With Refractory Solid Tumors	NCT00006463	Unspecified Chi...	ECTEINASCIDIN 7...	1 Year - 17 Years	Children's Oncology Group
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 ecteinascidin 743