Trial Outcomes & Findings for Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer (NCT NCT00995488)
NCT ID: NCT00995488
Last Updated: 2015-09-11
Results Overview
Clinical efficacy of ABI-007 based therapy will be determined by the overall response rate (Partial Response \[PR\] + Complete Response\[CR\]) to therapy. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Complete Response: Disappearance of all target lesions.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
2 years
Results posted on
2015-09-11
Participant Flow
Participant milestones
| Measure |
ABI-007
ABI-007 combined with Carboplatin, and Gemcitabine
|
|---|---|
|
Overall Study
STARTED
|
16
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ABI-007
ABI-007 combined with Carboplatin, and Gemcitabine
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Trial of Combination ABI-007, Carboplatin, and Gemcitabine for First Line Treatment of Advanced Urothelial Cancer
Baseline characteristics by cohort
| Measure |
ABI-007
n=16 Participants
ABI-007 combined with Carboplatin, and Gemcitabine
|
|---|---|
|
Age, Continuous
|
73.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Histology
Pure Urothelial
|
13 participants
n=5 Participants
|
|
Histology
Mixed Urothelial with Squamous
|
2 participants
n=5 Participants
|
|
Histology
Mixed Urothelial with Adenocarcinoma
|
1 participants
n=5 Participants
|
|
Primary Site
Bladder
|
13 participants
n=5 Participants
|
|
Primary Site
Ureter/ Renal Pelvis
|
3 participants
n=5 Participants
|
|
Disease Status
Metastatic
|
13 participants
n=5 Participants
|
|
Disease Status
Locally Advanced or Recurrent Unresectable
|
3 participants
n=5 Participants
|
|
GFR
Greater than or Equal to 60 mL/min
|
9 participants
n=5 Participants
|
|
GFR
Less than 60 mL/min
|
7 participants
n=5 Participants
|
|
ECOG Performance Status
0
|
4 participants
n=5 Participants
|
|
ECOG Performance Status
1
|
11 participants
n=5 Participants
|
|
ECOG Performance Status
2
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: 16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.
Clinical efficacy of ABI-007 based therapy will be determined by the overall response rate (Partial Response \[PR\] + Complete Response\[CR\]) to therapy. Partial Response: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions. Complete Response: Disappearance of all target lesions.
Outcome measures
| Measure |
ABI-007
n=15 Participants
ABI-007 combined with Carboplatin, and Gemcitabine
|
|---|---|
|
Percentage of Participants With a Partial or Complete Response
|
6.3 percentage of participants
Interval 0.2 to 32.0
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: 16 participants began treatment however one patient withdrew from the study and was therefore not evaluable.
The Median Overall Survival was captured in months.
Outcome measures
| Measure |
ABI-007
n=15 Participants
ABI-007 combined with Carboplatin, and Gemcitabine
|
|---|---|
|
Median Overall Survival
|
13.1 months
Interval 9.8 to 19.6
|
Adverse Events
ABI-007
Serious events: 11 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ABI-007
n=16 participants at risk
ABI-007 combined with Carboplatin, and Gemcitabine
|
|---|---|
|
Endocrine disorders
ADH Secretion Abnormality (SIADH)
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
12.5%
2/16 • Number of events 2
|
|
Cardiac disorders
Cardiac ischemia/infarction : Acute myocardial infarction
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Congestive Heart Failure
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhea
|
6.2%
1/16 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dissease Progression
|
6.2%
1/16 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
6.2%
1/16 • Number of events 1
|
|
Vascular disorders
Hemarthrosis
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Hemorrhage:GI
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
12.5%
2/16 • Number of events 2
|
|
Infections and infestations
Infection
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection documented microbiologically with Gr 3 or 4 neutrophils
|
6.2%
1/16 • Number of events 1
|
|
Infections and infestations
Infection-documented clinically with Gr 4 neutrophils- Skin (cellulitis)
|
6.2%
1/16 • Number of events 1
|
|
Blood and lymphatic system disorders
Leukopenia
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
18.8%
3/16 • Number of events 3
|
|
Gastrointestinal disorders
Mucositis
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
12.5%
2/16 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain-Back
|
6.2%
1/16 • Number of events 1
|
|
Cardiac disorders
Pain-Chest wall
|
6.2%
1/16 • Number of events 1
|
|
Eye disorders
Photophobia
|
6.2%
1/16 • Number of events 1
|
|
General disorders
Syncope
|
12.5%
2/16 • Number of events 2
|
|
Cardiac disorders
Ventricular Arrhythmia-Ventricular tachycardia
|
6.2%
1/16 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
6.2%
1/16 • Number of events 1
|
|
Metabolism and nutrition disorders
hyponatermia
|
6.2%
1/16 • Number of events 1
|
Other adverse events
| Measure |
ABI-007
n=16 participants at risk
ABI-007 combined with Carboplatin, and Gemcitabine
|
|---|---|
|
Investigations
ALT Increase
|
25.0%
4/16 • Number of events 4
|
|
Investigations
AST increase
|
12.5%
2/16 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
56.2%
9/16 • Number of events 10
|
|
Metabolism and nutrition disorders
Anorexia
|
31.2%
5/16 • Number of events 5
|
|
Blood and lymphatic system disorders
Leukocytopenia
|
87.5%
14/16 • Number of events 24
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
16/16 • Number of events 33
|
|
Blood and lymphatic system disorders
Lymphopenia
|
81.2%
13/16 • Number of events 18
|
|
Gastrointestinal disorders
Nausea
|
37.5%
6/16 • Number of events 8
|
|
Nervous system disorders
Neuropathy:Sensory
|
25.0%
4/16 • Number of events 4
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
100.0%
16/16 • Number of events 38
|
|
Gastrointestinal disorders
constipation
|
25.0%
4/16 • Number of events 4
|
|
Investigations
creatinine increase
|
18.8%
3/16 • Number of events 3
|
|
Nervous system disorders
dizziness
|
12.5%
2/16 • Number of events 2
|
|
General disorders
fatigue
|
75.0%
12/16 • Number of events 17
|
|
Metabolism and nutrition disorders
hyperglycemia
|
43.8%
7/16 • Number of events 8
|
|
Metabolism and nutrition disorders
hyponatremia
|
12.5%
2/16 • Number of events 2
|
|
Investigations
increase creatinine
|
12.5%
2/16 • Number of events 2
|
|
Blood and lymphatic system disorders
neutropenia
|
56.2%
9/16 • Number of events 21
|
|
General disorders
pain
|
12.5%
2/16 • Number of events 2
|
|
Gastrointestinal disorders
vomiting
|
12.5%
2/16 • Number of events 2
|
Additional Information
Dr. Maha Hussain
University of Michigan Comprehensive Cancer Center
Phone: 734-647-8903
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place