Trial Outcomes & Findings for Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma (NCT NCT02887248)
NCT ID: NCT02887248
Last Updated: 2023-12-05
Results Overview
The percentage of treated patients who are progression-free at 6 months after start of treatment, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
3 participants
Primary outcome timeframe
up to 26 weeks
Results posted on
2023-12-05
Participant Flow
Participant milestones
| Measure |
Nab-paclitaxel+Gemcitabine
Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.
Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Nab-paclitaxel+Gemcitabine
Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.
Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Progressive Disease
|
1
|
Baseline Characteristics
Nab-paclitaxel Plus Gemcitabine as First-line Therapy for Cisplatin-ineligible or Cisplatin-incurable Advanced Urothelial Carcinoma
Baseline characteristics by cohort
| Measure |
Nab-paclitaxel+Gemcitabine
n=3 Participants
Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.
Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 26 weeksPopulation: Analysis was not done as the study ended early because of slow recruitment
The percentage of treated patients who are progression-free at 6 months after start of treatment, assessed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest (nadir) sum since the treatment started, or the appearance of one or more new lesions. Requires not only 20% increase, but absolute increase of a minimum of 5 mm over sum.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 3 cycles (9 weeks) until treatment discontinuation, an expected average of 1 year.Population: Analysis was not done as the study ended early because of slow recruitment
The proportion of patients with a confirmed complete or partial response (CR or PR) according to RECIST v1.1. CR = disappearance of all target lesions. PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 3 cycles (9 weeks) until treatment discontinuation, an expected average of 1 year.Population: Analysis was not done as the study ended early because of slow recruitment
Defined as the proportion of patients with CR, PR, or stable disease (SD) according to RECIST v1.1. SD = neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease, taking as reference the smallest (nadir) sum of diameters since start of treatment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: every 9 weeks until disease progression or death on study, an expected average of 1 year. Patients with progressive disease will be followed every 3 months for the first year and every 6 months thereafter up to 5 years.Population: Analysis was not done as the study ended early because of slow recruitment
Defined as the time from Day 1 of study drug administration to disease progression or death on study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: through study completion, an average of 1 yearThe reported incidence of AEs with an onset on or after the initiation of therapy will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03.
Outcome measures
| Measure |
Nab-paclitaxel+Gemcitabine
n=3 Participants
Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.
Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment.
|
|---|---|
|
The Number of Participants With Grade 3/4/5 Adverse Events (AEs) as a Measure of Safety.
|
2 Participants
|
Adverse Events
Nab-paclitaxel+Gemcitabine
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Nab-paclitaxel+Gemcitabine
n=3 participants at risk
Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.
Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment.
|
|---|---|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
Other adverse events
| Measure |
Nab-paclitaxel+Gemcitabine
n=3 participants at risk
Induction Phase: nab-paclitaxel (125 mg/m²) and gemcitabine (1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle. Responding or stable patients will be treated with a minimum of 3 cycles and up to 6 cycles before starting the single agent maintenance therapy.
Maintenance Phase: Patients completing 3-6 cycles of induction therapy with an objective response (complete or partial response) or stable disease will continue treatment with single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment.
|
|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Investigations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Anaemia
|
66.7%
2/3 • Number of events 5 • through study completion, an average of 1 year
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
66.7%
2/3 • Number of events 2 • through study completion, an average of 1 year
|
|
Investigations
Aspartate aminotransferase increased
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
General disorders
Asthenia
|
33.3%
1/3 • Number of events 2 • through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Injury, poisoning and procedural complications
Contusion
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
100.0%
3/3 • Number of events 8 • through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
1/3 • Number of events 2 • through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
General disorders
Fatigue
|
66.7%
2/3 • Number of events 4 • through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Gout
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Renal and urinary disorders
Haematuria
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Psychiatric disorders
Hallucination
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
66.7%
2/3 • Number of events 4 • through study completion, an average of 1 year
|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 2 • through study completion, an average of 1 year
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
33.3%
1/3 • Number of events 3 • through study completion, an average of 1 year
|
|
General disorders
Malaise
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
General disorders
Mucosal inflammation
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
66.7%
2/3 • Number of events 2 • through study completion, an average of 1 year
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
1/3 • Number of events 2 • through study completion, an average of 1 year
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
General disorders
Oedema
|
33.3%
1/3 • Number of events 3 • through study completion, an average of 1 year
|
|
General disorders
Pain
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
General disorders
Pyrexia
|
33.3%
1/3 • Number of events 3 • through study completion, an average of 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
33.3%
1/3 • Number of events 3 • through study completion, an average of 1 year
|
|
Infections and infestations
Urinary tract infection
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
|
Investigations
White blood cell count decreased
|
33.3%
1/3 • Number of events 1 • through study completion, an average of 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place