Trial Outcomes & Findings for Dalantercept in Treating Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer (NCT NCT01720173)

NCT ID: NCT01720173

Last Updated: 2021-10-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

Every other cycle for first 6 months

Results posted on

2021-10-20

Participant Flow

The study was activated on 11/5/2012 and closed to accrual on 10/2/2013.

Participant milestones

Participant milestones
Measure	Dalantercept 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 Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dalantercept n=30 Participants 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.
Age, Continuous	57.0 years STANDARD_DEVIATION 9.2 • n=93 Participants
Age, Customized 30-39 years	1 Participants n=93 Participants
Age, Customized 40-49 years	6 Participants n=93 Participants
Age, Customized 50-59 years	13 Participants n=93 Participants
Age, Customized 60-69 years	5 Participants n=93 Participants
Age, Customized 70-79 years	5 Participants n=93 Participants
Sex: Female, Male Female	30 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Every other cycle for first 6 months

Population: Eligible and treated participants

Outcome measures

Outcome measures
Measure	Dalantercept n=30 Participants 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.
Progression-free for at Least 6 Months Without Non-protocol Therapy From Study Entry	20 percentage of participants Interval 11.0 to 100.0

PRIMARY outcome

Timeframe: Assessed every cycle while on treatment, 30 days after the last cycle of treatment, and up to 5 years in follow-up

Population: Eligible and treated patients

Number of participants with a maximum grade of 3 or higher during the treatment period.

Outcome measures

Outcome measures
Measure	Dalantercept n=30 Participants 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.
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Cardiac disorders	3 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Gastrointestinal disorders	2 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 General disorders and administration site conditio	2 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Infections and infestations	3 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Metabolism and nutrition disorders	1 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Musculoskeletal and connective tissue disorders	1 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Renal and urinary disorders	1 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Reproductive system and breast disorders	1 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Respiratory, thoracic and mediastinal disorders	1 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Neutropenia	1 Participants
Incidence of Adverse Effects as Assessed by Common Terminology Criteria for Adverse Events Version 4.0 Other Investigations	1 Participants

PRIMARY outcome

Timeframe: 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.

Population: Eligible and treated participants

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.

Outcome measures

Outcome measures
Measure	Dalantercept n=30 Participants 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.
Objective Tumor Response	0 percentage of participants Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 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.

Population: Eligible and treated participants.

Overall survival is defined as the duration of time from study entry to time of death or the date of last contact.

Outcome measures

Outcome measures
Measure	Dalantercept n=30 Participants 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 Survival	19.8 months Interval 8.8 to 24.4

SECONDARY outcome

Population: Eligible and treated participants

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.

Outcome measures

Outcome measures
Measure	Dalantercept n=30 Participants 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.
Progression-free Survival	1.7 months Interval 1.3 to 3.7

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Associated with measures of clinical response to treatment, including PFS and OS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Associated with measures of clinical response to treatment, including PFS and OS.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Associated with measures of clinical response to treatment, including PFS and OS.

Outcome measures

Outcome data not reported

Adverse Events

Dalantercept

Serious events: 8 serious events

Other events: 30 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dalantercept n=30 participants at risk 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.
Gastrointestinal disorders Colonic Obstruction	3.3% 1/30 • 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.
Gastrointestinal disorders Abdominal Pain	3.3% 1/30 • 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.
General disorders Fatigue	3.3% 1/30 • 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.
Infections and infestations Urinary Tract Infection	3.3% 1/30 • 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.
Metabolism and nutrition disorders Hypokalemia	3.3% 1/30 • 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.
Nervous system disorders Dysphasia	3.3% 1/30 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.3% 1/30 • 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.
Skin and subcutaneous tissue disorders Skin And Subcutaneous Tissue Disorders - Other	3.3% 1/30 • 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.

Other adverse events

Other adverse events
Measure	Dalantercept n=30 participants at risk 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.
Blood and lymphatic system disorders Lymph Node Pain	3.3% 1/30 • 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.
Blood and lymphatic system disorders Anemia	70.0% 21/30 • 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.
Cardiac disorders Palpitations	10.0% 3/30 • 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.
Cardiac disorders Heart Failure	3.3% 1/30 • 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.
Cardiac disorders Sinus Tachycardia	6.7% 2/30 • 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.
Ear and labyrinth disorders Vertigo	3.3% 1/30 • 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.
Ear and labyrinth disorders Tinnitus	10.0% 3/30 • 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.
Ear and labyrinth disorders Ear Pain	6.7% 2/30 • 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.
Endocrine disorders Hyperparathyroidism	3.3% 1/30 • 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.
Eye disorders Eye Disorders - Other	3.3% 1/30 • 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.
Eye disorders Blurred Vision	6.7% 2/30 • 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.
Gastrointestinal disorders Dyspepsia	10.0% 3/30 • 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.
Gastrointestinal disorders Dry Mouth	3.3% 1/30 • 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.
Gastrointestinal disorders Constipation	43.3% 13/30 • 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.
Gastrointestinal disorders Diarrhea	13.3% 4/30 • 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.
Gastrointestinal disorders Vomiting	20.0% 6/30 • 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.
Gastrointestinal disorders Bloating	13.3% 4/30 • 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.
Gastrointestinal disorders Abdominal Pain	46.7% 14/30 • 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.
Gastrointestinal disorders Oral Dysesthesia	3.3% 1/30 • 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.
Gastrointestinal disorders Mucositis Oral	3.3% 1/30 • 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.
Gastrointestinal disorders Lower Gastrointestinal Hemorrhage	3.3% 1/30 • 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.
Gastrointestinal disorders Gastrointestinal Disorders - Other	3.3% 1/30 • 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.
Gastrointestinal disorders Oral Hemorrhage	6.7% 2/30 • 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.
Gastrointestinal disorders Oral Pain	3.3% 1/30 • 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.
Gastrointestinal disorders Abdominal Distension	16.7% 5/30 • 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.
Gastrointestinal disorders Nausea	26.7% 8/30 • 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.
Gastrointestinal disorders Fecal Incontinence	3.3% 1/30 • 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.
Gastrointestinal disorders Ascites	20.0% 6/30 • 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.
Gastrointestinal disorders Flatulence	3.3% 1/30 • 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.
General disorders Pain	6.7% 2/30 • 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.
General disorders Malaise	6.7% 2/30 • 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.
General disorders Localized Edema	3.3% 1/30 • 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.
General disorders Injection Site Reaction	3.3% 1/30 • 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.
General disorders Edema Trunk	6.7% 2/30 • 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.
General disorders Non-Cardiac Chest Pain	3.3% 1/30 • 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.
General disorders Edema Limbs	36.7% 11/30 • 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.
General disorders Edema Face	3.3% 1/30 • 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.
General disorders Fatigue	66.7% 20/30 • 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.
General disorders Fever	16.7% 5/30 • 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.
General disorders Chills	10.0% 3/30 • 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.
Immune system disorders Allergic Reaction	3.3% 1/30 • 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.
Infections and infestations Peripheral Nerve Infection	3.3% 1/30 • 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.
Infections and infestations Lung Infection	3.3% 1/30 • 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.
Infections and infestations Lip Infection	3.3% 1/30 • 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.
Investigations Weight Loss	3.3% 1/30 • 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.
Investigations Weight Gain	26.7% 8/30 • 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.
Investigations Platelet Count Decreased	20.0% 6/30 • 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.
Investigations Lymphocyte Count Decreased	3.3% 1/30 • 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.
Investigations Creatinine Increased	10.0% 3/30 • 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.
Investigations Neutrophil Count Decreased	6.7% 2/30 • 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.
Investigations White Blood Cell Decreased	20.0% 6/30 • 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.
Investigations Aspartate Aminotransferase Increased	10.0% 3/30 • 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.
Investigations Alkaline Phosphatase Increased	10.0% 3/30 • 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.
Investigations Alanine Aminotransferase Increased	10.0% 3/30 • 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.
Investigations Activated Partial Thromboplastin Time Prolonged	3.3% 1/30 • 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.
Metabolism and nutrition disorders Hypophosphatemia	3.3% 1/30 • 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.
Metabolism and nutrition disorders Hyponatremia	16.7% 5/30 • 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.
Metabolism and nutrition disorders Hypomagnesemia	13.3% 4/30 • 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.
Metabolism and nutrition disorders Hypokalemia	16.7% 5/30 • 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.
Metabolism and nutrition disorders Hypoglycemia	3.3% 1/30 • 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.
Metabolism and nutrition disorders Hypocalcemia	6.7% 2/30 • 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.
Metabolism and nutrition disorders Hypoalbuminemia	36.7% 11/30 • 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.
Metabolism and nutrition disorders Hypertriglyceridemia	3.3% 1/30 • 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.
Metabolism and nutrition disorders Hypernatremia	6.7% 2/30 • 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.
Metabolism and nutrition disorders Hyperkalemia	10.0% 3/30 • 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.
Metabolism and nutrition disorders Hyperglycemia	10.0% 3/30 • 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.
Metabolism and nutrition disorders Hypercalcemia	3.3% 1/30 • 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.
Metabolism and nutrition disorders Dehydration	3.3% 1/30 • 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.
Metabolism and nutrition disorders Anorexia	16.7% 5/30 • 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.
Musculoskeletal and connective tissue disorders Pain In Extremity	6.7% 2/30 • 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.
Musculoskeletal and connective tissue disorders Osteoporosis	3.3% 1/30 • 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.
Musculoskeletal and connective tissue disorders Neck Pain	3.3% 1/30 • 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.
Musculoskeletal and connective tissue disorders Myalgia	26.7% 8/30 • 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.
Musculoskeletal and connective tissue disorders Chest Wall Pain	3.3% 1/30 • 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.
Musculoskeletal and connective tissue disorders Back Pain	13.3% 4/30 • 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.
Musculoskeletal and connective tissue disorders Arthralgia	13.3% 4/30 • 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.
Nervous system disorders Peripheral Sensory Neuropathy	33.3% 10/30 • 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.
Nervous system disorders Peripheral Motor Neuropathy	6.7% 2/30 • 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.
Nervous system disorders Paresthesia	10.0% 3/30 • 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.
Nervous system disorders Memory Impairment	3.3% 1/30 • 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.
Nervous system disorders Headache	50.0% 15/30 • 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.
Nervous system disorders Dizziness	10.0% 3/30 • 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.
Nervous system disorders Cognitive Disturbance	3.3% 1/30 • 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.
Psychiatric disorders Insomnia	13.3% 4/30 • 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.
Psychiatric disorders Depression	6.7% 2/30 • 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.
Psychiatric disorders Confusion	3.3% 1/30 • 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.
Psychiatric disorders Anxiety	6.7% 2/30 • 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.
Renal and urinary disorders Urinary Incontinence	3.3% 1/30 • 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.
Renal and urinary disorders Urinary Tract Pain	3.3% 1/30 • 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.
Renal and urinary disorders Acute Kidney Injury	3.3% 1/30 • 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.
Reproductive system and breast disorders Vaginal Hemorrhage	3.3% 1/30 • 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.
Reproductive system and breast disorders Pelvic Pain	6.7% 2/30 • 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.
Reproductive system and breast disorders Vaginal Discharge	3.3% 1/30 • 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.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic And Mediastinal Disorders -	3.3% 1/30 • 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.
Respiratory, thoracic and mediastinal disorders Sore Throat	6.7% 2/30 • 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.
Respiratory, thoracic and mediastinal disorders Sinus Disorder	3.3% 1/30 • 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.
Respiratory, thoracic and mediastinal disorders Pleural Effusion	3.3% 1/30 • 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.
Respiratory, thoracic and mediastinal disorders Nasal Congestion	10.0% 3/30 • 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.
Respiratory, thoracic and mediastinal disorders Pleuritic Pain	6.7% 2/30 • 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.
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 3/30 • 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.
Respiratory, thoracic and mediastinal disorders Dyspnea	20.0% 6/30 • 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.
Respiratory, thoracic and mediastinal disorders Cough	13.3% 4/30 • 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.
Skin and subcutaneous tissue disorders Rash Acneiform	3.3% 1/30 • 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.
Skin and subcutaneous tissue disorders Purpura	3.3% 1/30 • 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.
Skin and subcutaneous tissue disorders Pruritus	6.7% 2/30 • 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.
Skin and subcutaneous tissue disorders Periorbital Edema	3.3% 1/30 • 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.
Skin and subcutaneous tissue disorders Rash Maculo-Papular	16.7% 5/30 • 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.
Skin and subcutaneous tissue disorders Telangiectasia	6.7% 2/30 • 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.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.3% 1/30 • 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.
Skin and subcutaneous tissue disorders Erythema Multiforme	3.3% 1/30 • 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.
Skin and subcutaneous tissue disorders Alopecia	3.3% 1/30 • 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.
Vascular disorders Thromboembolic Event	3.3% 1/30 • 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.
Vascular disorders Lymphedema	3.3% 1/30 • 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.
Vascular disorders Hypertension	10.0% 3/30 • 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.
Vascular disorders Flushing	3.3% 1/30 • 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.

Additional Information

Angela Kuras on behalf of Wei Deng, PhD

NRG Oncology

Phone: 716-845-5702

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60