Trial Outcomes & Findings for Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery (NCT NCT01623869)

NCT ID: NCT01623869

Last Updated: 2015-10-19

Results Overview

Response and progression will be evaluated using the international RECIST guidelines (v1.1). Patients are evaluated every 8 weeks for disease status, with a subsequent 4 week assessment required to confirm a response. Complete Response (CR) - All of the following must be true: 1. Disappearance of all target and non-target lesions, 2. Each target lesion and non-target lymph node must have reduction in short axis to \<1.0 cm. Partial Response (PR): 1. At least a 30% decrease from the baseline measurements of the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation. 2. Persistence of one or more non-target lesions or non-target lymph nodes. The confirmed response rate is estimated as the number of patients having a CR or PR, divided by the number of eligible patients having at least one post-baseline assessment. The 95% confidence intervals provided using the method of Duffy and Santner.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: Up to 18 months
• Results posted on: 2015-10-19

Participant Flow

Participant milestones

Measure	Treatment (Trebananib) Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trebananib in Treating Patients With Advanced Angiosarcoma That Cannot Be Removed by Surgery

Baseline characteristics by cohort

Measure	Treatment (Trebananib) n=16 Participants Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Age, Continuous	68.5 years n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 18 months

Response and progression will be evaluated using the international RECIST guidelines (v1.1). Patients are evaluated every 8 weeks for disease status, with a subsequent 4 week assessment required to confirm a response.

Complete Response (CR) - All of the following must be true:

1. Disappearance of all target and non-target lesions,

2. Each target lesion and non-target lymph node must have reduction in short axis to <1.0 cm.

Partial Response (PR):

1. At least a 30% decrease from the baseline measurements of the sum of the longest diameter for all target lesions plus the sum of the short axis of all the target lymph nodes at current evaluation.

2. Persistence of one or more non-target lesions or non-target lymph nodes. The confirmed response rate is estimated as the number of patients having a CR or PR, divided by the number of eligible patients having at least one post-baseline assessment. The 95% confidence intervals provided using the method of Duffy and Santner.

Outcome measures

Measure	Treatment (Trebananib) n=16 Participants Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Confirmed Response Rate (CR or PR) Using RECIST	0 percentage of participants Interval 0.0 to 20.6

SECONDARY outcome

Timeframe: From the start of treatment to time of radiologic or clinical progression or death, whichever occurs first, assessed up to 18 months

Progression-free survival (PFS) is defined as the duration of time from the start of treatment to time of radiologic or clinical progression or death, whichever occurs first. PFS will be censored at most recent radiographic assessment date for patients remaining alive at the time of the statistical analysis. Kaplan-Meier methodology will be used to estimate the distribution of PFS.

Outcome measures

Measure	Treatment (Trebananib) n=16 Participants Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Progression Free Survival (PFS)	1.6 months Interval 1.4 to 1.7

SECONDARY outcome

Timeframe: From the date of registration to the date of death or the date of last follow-up, assessed up to 18 months

Overall survival (OS) is the duration of time from the date of registration/randomization to the date of death or the date of last follow-up for patients who remain alive or who are lost to follow-up at the time of the analysis. Kaplan-Meier methodology will be used to estimate the distribution of OS.

Outcome measures

Measure	Treatment (Trebananib) n=16 Participants Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
OS	6.4 months Interval 4.0 to 11.1

Adverse Events

Treatment (Trebananib)

Serious events: 6 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Treatment (Trebananib) n=16 participants at risk Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Cardiac disorders Cardiac arrest	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Infections and infestations Wound infection	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations Activated partial thromboplastin time prolonged	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Hypocalcemia	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Hyponatremia	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Musculoskeletal and connective tissue disorders Chest wall pain	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Nervous system disorders Syncope	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Respiratory, thoracic and mediastinal disorders Dyspnea	12.5% 2/16 • Number of events 2 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Respiratory, thoracic and mediastinal disorders Respiratory failure	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Vascular disorders Hematoma	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Vascular disorders Thromboembolic event	12.5% 2/16 • Number of events 3 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.

Other adverse events

Measure	Treatment (Trebananib) n=16 participants at risk Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders Anemia	18.8% 3/16 • Number of events 4 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Gastrointestinal disorders Mucositis oral	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Gastrointestinal disorders Nausea	12.5% 2/16 • Number of events 2 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
General disorders Edema face	12.5% 2/16 • Number of events 6 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
General disorders Edema limbs	43.8% 7/16 • Number of events 19 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
General disorders Fatigue	18.8% 3/16 • Number of events 3 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
General disorders Pain	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Immune system disorders Allergic reaction	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Infections and infestations Infections and infestations - Other, specify	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Infections and infestations Urinary tract infection	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations Activated partial thromboplastin time prolonged	12.5% 2/16 • Number of events 6 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations Alanine aminotransferase increased	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations Alkaline phosphatase increased	12.5% 2/16 • Number of events 3 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations Aspartate aminotransferase increased	18.8% 3/16 • Number of events 3 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations Blood bilirubin increased	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations CD4 lymphocytes decreased	6.2% 1/16 • Number of events 3 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations Creatinine increased	6.2% 1/16 • Number of events 2 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations INR increased	12.5% 2/16 • Number of events 2 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations Lymphocyte count decreased	18.8% 3/16 • Number of events 5 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Investigations Platelet count decreased	12.5% 2/16 • Number of events 4 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Anorexia	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Hyperglycemia	12.5% 2/16 • Number of events 2 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Hyperkalemia	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Hypoalbuminemia	18.8% 3/16 • Number of events 7 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Hypocalcemia	12.5% 2/16 • Number of events 6 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Hypokalemia	12.5% 2/16 • Number of events 3 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Hyponatremia	25.0% 4/16 • Number of events 6 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other, specify	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Musculoskeletal and connective tissue disorders Arthralgia	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Musculoskeletal and connective tissue disorders Pain in extremity	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Nervous system disorders Peripheral motor neuropathy	6.2% 1/16 • Number of events 2 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Nervous system disorders Peripheral sensory neuropathy	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Renal and urinary disorders Hematuria	6.2% 1/16 • Number of events 2 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Respiratory, thoracic and mediastinal disorders Cough	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Respiratory, thoracic and mediastinal disorders Dyspnea	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Respiratory, thoracic and mediastinal disorders Pleural effusion	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Respiratory, thoracic and mediastinal disorders Pulmonary edema	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Skin and subcutaneous tissue disorders Periorbital edema	12.5% 2/16 • Number of events 4 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Skin and subcutaneous tissue disorders Rash acneiform	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Skin and subcutaneous tissue disorders Rash maculo-papular	12.5% 2/16 • Number of events 2 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Vascular disorders Hypertension	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.
Vascular disorders Lymphedema	6.2% 1/16 • Number of events 1 • Evaluated monthly from the date of randomization until 30 days following a patient's last dose. Maximum severity per AE classification is reported, per patient.

Additional Information

Sandra Pierina D'Angelo, M.D.

Memorial Sloan-Kettering Cancer Center

Email: dangelos@mskcc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60