Trial Outcomes & Findings for Ramucirumab in Treating Patients With Advanced or Metastatic, Previously Treated Biliary Cancers That Cannot Be Removed by Surgery (NCT NCT02520141)
NCT ID: NCT02520141
Last Updated: 2023-06-15
Results Overview
Progression free survival is measured using 95% confidence intervals. From the date of treatment start to the date of disease progression or to the date of death, whichever occurs first, or to the last follow-up date if patients are alive without disease progression, assessed up to at least 3 months post-treatment
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Up to 6 years
Results posted on
2023-06-15
Participant Flow
MD Anderson Cancer Center Houston Tx
Participant milestones
| Measure |
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
|
|---|---|
|
Overall Study
Rapid decline clinically and thus unable to enroll
|
1
|
Baseline Characteristics
Race and Ethnicity Not Collected
Baseline characteristics by cohort
| Measure |
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
n=60 Participants
Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
|
|---|---|
|
Age, Continuous
|
58.5 years
n=60 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
Race and Ethnicity Not Collected
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
Race and Ethnicity Not Collected
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
Race and Ethnicity Not Collected
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
Race and Ethnicity Not Collected
|
|
Race (NIH/OMB)
Asian
|
0 Participants
Race and Ethnicity Not Collected
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
Race and Ethnicity Not Collected
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
Race and Ethnicity Not Collected
|
|
Race (NIH/OMB)
White
|
0 Participants
Race and Ethnicity Not Collected
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
Race and Ethnicity Not Collected
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
Race and Ethnicity Not Collected
|
PRIMARY outcome
Timeframe: Up to 6 yearsProgression free survival is measured using 95% confidence intervals. From the date of treatment start to the date of disease progression or to the date of death, whichever occurs first, or to the last follow-up date if patients are alive without disease progression, assessed up to at least 3 months post-treatment
Outcome measures
| Measure |
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
n=60 Participants
Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
|
|---|---|
|
Progression Free Survival of Ramucirumab in Advanced Biliary Cancers
|
3.2 months
Interval 2.1 to 4.8
|
SECONDARY outcome
Timeframe: Up to 6 yearsOveral Survival (OS): the time from treatment initiation to death from any cause. OS functions were estimated using the Kaplan-Meier method .
Outcome measures
| Measure |
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
n=60 Participants
Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
|
|---|---|
|
Overall Survival (OS)
|
9.5 Months
Interval 5.81 to 13.6
|
SECONDARY outcome
Timeframe: Up to 6 yearsThe proportion of patients with the best overall response of complete response or partial response (PR)\]
Outcome measures
| Measure |
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
n=60 Participants
Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
|
|---|---|
|
Overall Response Rate (RR)
|
1 participants
|
SECONDARY outcome
Timeframe: Up to 6 yearsPartial Response + Complete Response + Stable Disease (ORR + Stable Disease)
Outcome measures
| Measure |
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
n=60 Participants
Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
|
|---|---|
|
Percentage of Disease Control Rate
|
45 percentage
|
Adverse Events
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
Serious events: 1 serious events
Other events: 60 other events
Deaths: 60 deaths
Serious adverse events
| Measure |
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
n=60 participants at risk
Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
|
|---|---|
|
Gastrointestinal disorders
Upper GI Bleeding
|
1.7%
1/60 • Number of events 1 • Up to 6 years
NCI CTCAE version 4.0.
|
Other adverse events
| Measure |
Phase II Open-label, Single Arm Study of Ramucirumab Administered at 8 mg/kg IV.
n=60 participants at risk
Phase II, single-arm trial for advanced, unresectable, pre-treated patients with BTC. Eligible patients received ramucirumab 8 mg/kg IV on day 1 of a 14-day cycle until progression or intolerable toxicity.
|
|---|---|
|
Investigations
Proteinuria
|
38.3%
23/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Thrombocytopenia
|
21.7%
13/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Anemia
|
18.3%
11/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hyperbilirubinemia
|
15.0%
9/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Alkaline phosphatase increase
|
15.0%
9/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
AST increase
|
15.0%
9/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hyponatremia
|
15.0%
9/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
ALT increase
|
13.3%
8/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hyperkalemia
|
11.7%
7/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hypercalcemia
|
8.3%
5/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hypomagnesemia
|
8.3%
5/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Creatinine
|
6.7%
4/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hypoalbuminemia
|
5.0%
3/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hematuria
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hypermagnesemia
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hypoglycemia
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hypokalemia
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Prolonged PTT
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hyperglycemia
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hypocalcemia
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hypophosphatemia
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Hypotension
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Investigations
Increased INR
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Vascular disorders
Hypertension
|
41.7%
25/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Upper GI hemorrhage
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Vascular disorders
Pulmonary embolism
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
General disorders
Fatigue
|
38.3%
23/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Nervous system disorders
Headache
|
35.0%
21/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Nausea and vomiting
|
26.7%
16/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Abdominal pain
|
23.3%
14/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
23.3%
14/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Vascular disorders
Lower extremity edema
|
21.7%
13/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Anorexia
|
20.0%
12/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Constipation
|
18.3%
11/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
General disorders
Fever
|
18.3%
11/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Nervous system disorders
Dizziness
|
15.0%
9/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Ascites
|
13.3%
8/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.7%
7/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Nervous system disorders
Extremity pain
|
11.7%
7/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
6/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
6/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Renal and urinary disorders
Urinary tract infection
|
10.0%
6/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
5/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Nervous system disorders
Neuropathy
|
8.3%
5/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
4/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Immune system disorders
Allergic rhinitis
|
6.7%
4/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
6.7%
4/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
General disorders
Diaphoresis
|
6.7%
4/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Mucositis
|
6.7%
4/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Infections and infestations
Sepsis
|
6.7%
4/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Nervous system disorders
Confusion
|
5.0%
3/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
General disorders
Dehydration
|
5.0%
3/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Gastric obstruction
|
5.0%
3/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
5.0%
3/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
5.0%
3/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
General disorders
Chills
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Cholangitis
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
General disorders
Hot flashes
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
General disorders
Pruritus
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Vascular disorders
Thrombocytopenic purpura
|
3.3%
2/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Biliary obstruction
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Nervous system disorders
Blurry vision
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Nervous system disorders
Delirium
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
General disorders
Facial edema
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Vascular disorders
Epistaxis
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Esophagitis
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Gastroparesis
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
|
Gastrointestinal disorders
Hiccups
|
1.7%
1/60 • Up to 6 years
NCI CTCAE version 4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place