Trial Outcomes & Findings for Trial of Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma (NCT NCT01331824)
NCT ID: NCT01331824
Last Updated: 2018-04-23
Results Overview
Response to treatment based on tumor measurements via CT chest, abdomen, and pelvis for restaging after every 2 cycles. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
6 weeks
Results posted on
2018-04-23
Participant Flow
Participant milestones
| Measure |
Amrubicin
Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
9
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Amrubicin
Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Death
|
1
|
|
Overall Study
Disease Progression
|
9
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Trial of Amrubicin as Second-Line Therapy in Patients With Advanced/Metastatic Refractory Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Amrubicin
n=22 Participants
Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
|
|---|---|
|
Prior "first-line" treatment
Neoadjuvant
|
4 participants
n=5 Participants
|
|
Prior "first-line" treatment
Adjuvant
|
4 participants
n=5 Participants
|
|
Age, Continuous
|
65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Primary Site
Bladder
|
16 participants
n=5 Participants
|
|
Primary Site
Renal Pelvis
|
3 participants
n=5 Participants
|
|
Primary Site
Urethra
|
3 participants
n=5 Participants
|
|
Prior "first-line" treatment
Metastatic
|
14 participants
n=5 Participants
|
|
First-line chemotherapy regimen
Gemcitabine + carboplatin
|
7 participants
n=5 Participants
|
|
First-line chemotherapy regimen
Gemcitabine + cisplatin
|
12 participants
n=5 Participants
|
|
First-line chemotherapy regimen
Gemcitabine + cisplatin + dovitinib
|
1 participants
n=5 Participants
|
|
First-line chemotherapy regimen
Gemcitabine + cisplatin + ipilimumab
|
1 participants
n=5 Participants
|
|
First-line chemotherapy regimen
Gemcitabine + doxorubicin + paclitaxel
|
1 participants
n=5 Participants
|
|
Bellmunt prognostic factors
0 poor prognostic factors
|
3 participants
n=5 Participants
|
|
Bellmunt prognostic factors
1 poor prognostic factors
|
10 participants
n=5 Participants
|
|
Bellmunt prognostic factors
2 poor prognostic factors
|
6 participants
n=5 Participants
|
|
Bellmunt prognostic factors
3 poor prognostic factors
|
3 participants
n=5 Participants
|
|
Median time from prior chemotherapy
|
6.8 months
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 weeksResponse to treatment based on tumor measurements via CT chest, abdomen, and pelvis for restaging after every 2 cycles. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Outcome measures
| Measure |
Amrubicin
n=22 Participants
Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
|
|---|---|
|
Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Partial response
|
13.6 percentage of participants
Interval 0.0 to 28.0
|
|
Objective Response Rate as Measured by Response Evaluation Criteria in Solid Tumors (RECIST 1.1)
Stable disease
|
54.5 percentage of participants
Interval 33.7 to 75.3
|
SECONDARY outcome
Timeframe: Every 3 months post Amrubicin administrationThe median progression-free survival After the last dose of Amrubicin, patients will have follow-up every 3 months with a repeat CT scan of the chest, abdomen, and pelvis until the time of disease progression is documented.
Outcome measures
| Measure |
Amrubicin
n=22 Participants
Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
|
|---|---|
|
Progression-free Survival
|
3.4 months
Interval 2.1 to 4.8
|
SECONDARY outcome
Timeframe: 1 yearThe median overall survival
Outcome measures
| Measure |
Amrubicin
n=22 Participants
Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
|
|---|---|
|
Overall Survival
|
7.2 months
Interval 4.2 to 10.1
|
SECONDARY outcome
Timeframe: Day 1 of each treatment cycle; and 21 days after the last dose of amrubicinTypes of adverse events listed in Adverse Event Section
Outcome measures
| Measure |
Amrubicin
n=22 Participants
Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
|
|---|---|
|
Safety as Measured by the Frequency and Type of Adverse Events as Per the Common Terminology for Adverse Events (CTCAE) Version 4.0.
|
117 adverse events
|
Adverse Events
Amrubicin
Serious events: 3 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Amrubicin
n=22 participants at risk
Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.5%
1/22 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.6%
3/22 • Number of events 4
|
Other adverse events
| Measure |
Amrubicin
n=22 participants at risk
Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
59.1%
13/22
|
|
Blood and lymphatic system disorders
Anemia
|
45.5%
10/22
|
|
General disorders
Anorexia
|
27.3%
6/22
|
|
Skin and subcutaneous tissue disorders
Cellulitis
|
4.5%
1/22
|
|
Eye disorders
Conjunctival irritation
|
4.5%
1/22
|
|
Gastrointestinal disorders
Constipation
|
13.6%
3/22
|
|
Renal and urinary disorders
Creatinine increase
|
4.5%
1/22
|
|
Gastrointestinal disorders
Diarrhea
|
13.6%
3/22
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
13.6%
3/22
|
|
General disorders
Fatigue
|
59.1%
13/22
|
|
General disorders
Fever
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.5%
1/22
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
2/22
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.6%
3/22
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.5%
1/22
|
|
Injury, poisoning and procedural complications
Mucositis
|
40.9%
9/22
|
|
General disorders
Nausea
|
40.9%
9/22
|
|
Blood and lymphatic system disorders
Neutropenia
|
18.2%
4/22
|
|
General disorders
Taste alteration
|
9.1%
2/22
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
45.5%
10/22
|
|
Renal and urinary disorders
Urinary frequency
|
4.5%
1/22
|
|
General disorders
Vomiting
|
31.8%
7/22
|
|
Nervous system disorders
Weakness
|
9.1%
2/22
|
|
General disorders
Weight loss
|
13.6%
3/22
|
Additional Information
Dr. Matthew D. Galsky
Icahn School of Medicine at Mount Sinai
Phone: 212-241-6756
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place