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Trial record 53 of 526 for:    "Primary Peritoneal Carcinoma"

Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01720173
Recruitment Status : Active, not recruiting
First Posted : November 2, 2012
Results First Posted : December 8, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Biological: Dalantercept
Other: Laboratory Biomarker Analysis
Enrollment 30
Recruitment Details The study was activated on 11/5/2012 and closed to accrual on 10/2/2013.
Pre-assignment Details  
Arm/Group Title Dalantercept
Hide Arm/Group Description

Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

Period Title: Overall Study
Started 30
Completed [1] 30
Not Completed 0
[1]
Eligible and treated patients.
Arm/Group Title Dalantercept
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Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

Overall Number of Baseline Participants 30
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Eligible and treated patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants
57.0  (9.2)
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
30-39 years
1
   3.3%
40-49 years
6
  20.0%
50-59 years
13
  43.3%
60-69 years
5
  16.7%
70-79 years
5
  16.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
30
 100.0%
Male
0
   0.0%
1.Primary Outcome
Title Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry
Hide Description Percentage of participants who survive progression-free for at least 6 months without non-protocol therapy after study entry. Progression is assessed by RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Time Frame Every other cycle for first 6 months
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Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title Dalantercept
Hide Arm/Group Description:

Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

Overall Number of Participants Analyzed 30
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
20
(11 to 100)
2.Primary Outcome
Title Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0
Hide Description Number of participants with a maximum grade of 3 or higher during the treatment period.
Time Frame Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up
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Hide Analysis Population Description
Eligible and treated patients
Arm/Group Title Dalantercept
Hide Arm/Group Description:

Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
Neutropenia
1
   3.3%
Other Investigations
1
   3.3%
Cardiac disorders
3
  10.0%
Gastrointestinal disorders
2
   6.7%
General disorders and administration site conditio
2
   6.7%
Infections and infestations
3
  10.0%
Metabolism and nutrition disorders
1
   3.3%
Musculoskeletal and connective tissue disorders
1
   3.3%
Renal and urinary disorders
1
   3.3%
Reproductive system and breast disorders
1
   3.3%
Respiratory, thoracic and mediastinal disorders
1
   3.3%
3.Primary Outcome
Title Objective Tumor Response
Hide Description Complete and Partial Tumor Response by RECIST 1.1. RECIST 1.1 defines complete response as the disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm and the disappearance of all non-target lesions and normalization of tumor marker level. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Only those patients who have measurable disease present at baseline, have received at least one cycle of therapy, and have had their disease re-evaluated will be considered evaluable for response. These patients will have their response classified according to the definitions stated above. Complete and partial responses are included in the objective tumor response rate.
Time Frame Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.
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Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title Dalantercept
Hide Arm/Group Description:

Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

Overall Number of Participants Analyzed 30
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 100)
4.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.
Time Frame Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants.
Arm/Group Title Dalantercept
Hide Arm/Group Description:

Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
19.8
(8.8 to 24.4)
5.Secondary Outcome
Title Progression-free Survival
Hide Description Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1. RECIST 1.1 defines progressive disease as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions or unequivocal progression of non-target lesions is also considered progression.
Time Frame Every other cycle for first 6 months; then every 3 months thereafter until disease progression confirmed; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease, up to 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible and treated participants
Arm/Group Title Dalantercept
Hide Arm/Group Description:

Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
1.7
(1.3 to 3.7)
6.Other Pre-specified Outcome
Title Gene Expression Levels of ALK1 and Other Markers
Hide Description Associated with measures of clinical response to treatment, including PFS and OS.
Time Frame Baseline
Outcome Measure Data Not Reported
7.Other Pre-specified Outcome
Title IHC Expression Levels of VEGF, FGF, TGFB, ALK1, CD105 and Other Markers
Hide Description Associated with measures of clinical response to treatment, including PFS and OS.
Time Frame Baseline
Outcome Measure Data Not Reported
8.Other Pre-specified Outcome
Title Pre-treatment Plasma Concentration Levels of VEGF, BMP9, BMP10, and ALK1
Hide Description Associated with measures of clinical response to treatment, including PFS and OS.
Time Frame Baseline
Outcome Measure Data Not Reported
Time Frame All Adverse Events (AEs) occurring during treatment and up to 30 days after stopping the study treatment are reported. The average time of study treatment was 3 months.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dalantercept
Hide Arm/Group Description

Dalantercept administered subcutaneously at a dose of 1.2mg/kg (maximum starting dose of 120 mg*) once every three weeks until disease progression or adverse effects prohibit further therapy. One cycle is 3 weeks.

*Patients weighing more than 100kg will start treatment at 120mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.

All-Cause Mortality
Dalantercept
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dalantercept
Affected / at Risk (%)
Total   8/30 (26.67%) 
Gastrointestinal disorders   
Colonic Obstruction * 1  1/30 (3.33%) 
Abdominal Pain * 1  1/30 (3.33%) 
General disorders   
Fatigue * 1  1/30 (3.33%) 
Infections and infestations   
Urinary Tract Infection * 1  1/30 (3.33%) 
Metabolism and nutrition disorders   
Hypokalemia * 1  1/30 (3.33%) 
Nervous system disorders   
Dysphasia * 1  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  1/30 (3.33%) 
Skin and subcutaneous tissue disorders   
Skin And Subcutaneous Tissue Disorders - Other * 1  1/30 (3.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Dalantercept
Affected / at Risk (%)
Total   30/30 (100.00%) 
Blood and lymphatic system disorders   
Lymph Node Pain * 1  1/30 (3.33%) 
Anemia * 1  21/30 (70.00%) 
Cardiac disorders   
Palpitations * 1  3/30 (10.00%) 
Heart Failure * 1  1/30 (3.33%) 
Sinus Tachycardia * 1  2/30 (6.67%) 
Ear and labyrinth disorders   
Vertigo * 1  1/30 (3.33%) 
Tinnitus * 1  3/30 (10.00%) 
Ear Pain * 1  2/30 (6.67%) 
Endocrine disorders   
Hyperparathyroidism * 1  1/30 (3.33%) 
Eye disorders   
Eye Disorders - Other * 1  1/30 (3.33%) 
Blurred Vision * 1  2/30 (6.67%) 
Gastrointestinal disorders   
Dyspepsia * 1  3/30 (10.00%) 
Dry Mouth * 1  1/30 (3.33%) 
Constipation * 1  13/30 (43.33%) 
Diarrhea * 1  4/30 (13.33%) 
Vomiting * 1  6/30 (20.00%) 
Bloating * 1  4/30 (13.33%) 
Abdominal Pain * 1  14/30 (46.67%) 
Oral Dysesthesia * 1  1/30 (3.33%) 
Mucositis Oral * 1  1/30 (3.33%) 
Lower Gastrointestinal Hemorrhage * 1  1/30 (3.33%) 
Gastrointestinal Disorders - Other * 1  1/30 (3.33%) 
Oral Hemorrhage * 1  2/30 (6.67%) 
Oral Pain * 1  1/30 (3.33%) 
Abdominal Distension * 1  5/30 (16.67%) 
Nausea * 1  8/30 (26.67%) 
Fecal Incontinence * 1  1/30 (3.33%) 
Ascites * 1  6/30 (20.00%) 
Flatulence * 1  1/30 (3.33%) 
General disorders   
Pain * 1  2/30 (6.67%) 
Malaise * 1  2/30 (6.67%) 
Localized Edema * 1  1/30 (3.33%) 
Injection Site Reaction * 1  1/30 (3.33%) 
Edema Trunk * 1  2/30 (6.67%) 
Non-Cardiac Chest Pain * 1  1/30 (3.33%) 
Edema Limbs * 1  11/30 (36.67%) 
Edema Face * 1  1/30 (3.33%) 
Fatigue * 1  20/30 (66.67%) 
Fever * 1  5/30 (16.67%) 
Chills * 1  3/30 (10.00%) 
Immune system disorders   
Allergic Reaction * 1  1/30 (3.33%) 
Infections and infestations   
Peripheral Nerve Infection * 1  1/30 (3.33%) 
Lung Infection * 1  1/30 (3.33%) 
Lip Infection * 1  1/30 (3.33%) 
Investigations   
Weight Loss * 1  1/30 (3.33%) 
Weight Gain * 1  8/30 (26.67%) 
Platelet Count Decreased * 1  6/30 (20.00%) 
Lymphocyte Count Decreased * 1  1/30 (3.33%) 
Creatinine Increased * 1  3/30 (10.00%) 
Neutrophil Count Decreased * 1  2/30 (6.67%) 
White Blood Cell Decreased * 1  6/30 (20.00%) 
Aspartate Aminotransferase Increased * 1  3/30 (10.00%) 
Alkaline Phosphatase Increased * 1  3/30 (10.00%) 
Alanine Aminotransferase Increased * 1  3/30 (10.00%) 
Activated Partial Thromboplastin Time Prolonged * 1  1/30 (3.33%) 
Metabolism and nutrition disorders   
Hypophosphatemia * 1  1/30 (3.33%) 
Hyponatremia * 1  5/30 (16.67%) 
Hypomagnesemia * 1  4/30 (13.33%) 
Hypokalemia * 1  5/30 (16.67%) 
Hypoglycemia * 1  1/30 (3.33%) 
Hypocalcemia * 1  2/30 (6.67%) 
Hypoalbuminemia * 1  11/30 (36.67%) 
Hypertriglyceridemia * 1  1/30 (3.33%) 
Hypernatremia * 1  2/30 (6.67%) 
Hyperkalemia * 1  3/30 (10.00%) 
Hyperglycemia * 1  3/30 (10.00%) 
Hypercalcemia * 1  1/30 (3.33%) 
Dehydration * 1  1/30 (3.33%) 
Anorexia * 1  5/30 (16.67%) 
Musculoskeletal and connective tissue disorders   
Pain In Extremity * 1  2/30 (6.67%) 
Osteoporosis * 1  1/30 (3.33%) 
Neck Pain * 1  1/30 (3.33%) 
Myalgia * 1  8/30 (26.67%) 
Chest Wall Pain * 1  1/30 (3.33%) 
Back Pain * 1  4/30 (13.33%) 
Arthralgia * 1  4/30 (13.33%) 
Nervous system disorders   
Peripheral Sensory Neuropathy * 1  10/30 (33.33%) 
Peripheral Motor Neuropathy * 1  2/30 (6.67%) 
Paresthesia * 1  3/30 (10.00%) 
Memory Impairment * 1  1/30 (3.33%) 
Headache * 1  15/30 (50.00%) 
Dizziness * 1  3/30 (10.00%) 
Cognitive Disturbance * 1  1/30 (3.33%) 
Psychiatric disorders   
Insomnia * 1  4/30 (13.33%) 
Depression * 1  2/30 (6.67%) 
Confusion * 1  1/30 (3.33%) 
Anxiety * 1  2/30 (6.67%) 
Renal and urinary disorders   
Urinary Incontinence * 1  1/30 (3.33%) 
Urinary Tract Pain * 1  1/30 (3.33%) 
Acute Kidney Injury * 1  1/30 (3.33%) 
Reproductive system and breast disorders   
Vaginal Hemorrhage * 1  1/30 (3.33%) 
Pelvic Pain * 1  2/30 (6.67%) 
Vaginal Discharge * 1  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory, Thoracic And Mediastinal Disorders - * 1  1/30 (3.33%) 
Sore Throat * 1  2/30 (6.67%) 
Sinus Disorder * 1  1/30 (3.33%) 
Pleural Effusion * 1  1/30 (3.33%) 
Nasal Congestion * 1  3/30 (10.00%) 
Pleuritic Pain * 1  2/30 (6.67%) 
Epistaxis * 1  3/30 (10.00%) 
Dyspnea * 1  6/30 (20.00%) 
Cough * 1  4/30 (13.33%) 
Skin and subcutaneous tissue disorders   
Rash Acneiform * 1  1/30 (3.33%) 
Purpura * 1  1/30 (3.33%) 
Pruritus * 1  2/30 (6.67%) 
Periorbital Edema * 1  1/30 (3.33%) 
Rash Maculo-Papular * 1  5/30 (16.67%) 
Telangiectasia * 1  2/30 (6.67%) 
Hyperhidrosis * 1  1/30 (3.33%) 
Erythema Multiforme * 1  1/30 (3.33%) 
Alopecia * 1  1/30 (3.33%) 
Vascular disorders   
Thromboembolic Event * 1  1/30 (3.33%) 
Lymphedema * 1  1/30 (3.33%) 
Hypertension * 1  3/30 (10.00%) 
Flushing * 1  1/30 (3.33%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Angela Kuras on behalf of Wei Deng, PhD
Organization: NRG Oncology
Phone: 716-845-5702
Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01720173     History of Changes
Other Study ID Numbers: GOG-0170R
NCI-2012-01936 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NSC #757172
CDR0000742512
GOG-0170R ( Other Identifier: NRG Oncology )
GOG-0170R ( Other Identifier: CTEP )
U10CA180868 ( U.S. NIH Grant/Contract )
U10CA027469 ( U.S. NIH Grant/Contract )
First Submitted: October 30, 2012
First Posted: November 2, 2012
Results First Submitted: August 3, 2017
Results First Posted: December 8, 2017
Last Update Posted: March 20, 2019