Trial Outcomes & Findings for A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer (NCT NCT00661609)
NCT ID: NCT00661609
Last Updated: 2011-01-12
Results Overview
Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).
COMPLETED
PHASE2
54 participants
8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)
2011-01-12
Participant Flow
Patients were recruited at 23 study sites in 5 countries: United States (7 centers), United Kingdom (6 centers), Germany (5 centers), Canada (3 centers), and Spain (2 centers) between 29 May 2008 and 11 January 2010. 54 participants were enrolled into the study of which 41 participants received at least one dose of study medication.
Following enrolment there was a screening period of up to 28 days, after which if all inclusion/exclusion criteria were met, patients were dosed with AZD4877.
Participant milestones
| Measure |
AZD4877
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
41
|
Reasons for withdrawal
| Measure |
AZD4877
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
|
|---|---|
|
Overall Study
Adverse Event
|
4
|
|
Overall Study
Death
|
20
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
PI Decision
|
1
|
|
Overall Study
Survival follow up stage discontinued
|
11
|
|
Overall Study
Disease progression
|
3
|
Baseline Characteristics
A Phase II Study of AZD4877 (a Novel Anti-mitotic Agent) in Advanced Bladder Cancer
Baseline characteristics by cohort
| Measure |
AZD4877
n=41 Participants
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
|
|---|---|
|
Age, Customized
>=18 - <65 Years
|
17 Participants
n=5 Participants
|
|
Age, Customized
>=65 - <75 Years
|
19 Participants
n=5 Participants
|
|
Age, Customized
>=75 Years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
40 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black and African
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 8 weeks after study drug begins & and every 8 wks thereafter until discontinuation of study drug ( maximum treatment period of 309 days (44 weeks)Population: Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).
Percentage of participants with complete response (CR) or partial response (PR) as per Response Evaluation Criteria In Solid Tumors (RECIST), version 1.0 (Therasse et al. Natl Cancer Inst 92 (2000) pp205-216).
Outcome measures
| Measure |
AZD4877
n=39 Participants
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
|
|---|---|
|
Objective Response Rate (ORR) as Evaluated by Response Evaluation Criteria In Solid Tumors (RECIST)
|
2.6 Percengate of participants
|
SECONDARY outcome
Timeframe: 8 weeks after study drug begins & every 8 weeks thereafter until discontinuation of the study ( maximum treatment period of 309 days (44 weeks)Population: Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).
Percentage of participants with Complete Response (CR), Partial Response (PR), or stable disease (SD) lasting at least 8 weeks from the first administration of study drug. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0).
Outcome measures
| Measure |
AZD4877
n=39 Participants
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
|
|---|---|
|
Disease Control Rate (DCR)
|
20.5 Percentage of participants
|
SECONDARY outcome
Timeframe: Time from first documentation of Complete or Partial Response, whichever occurs earlier, to discontinuation of the study drug (maximum treatment period of 309 days (44 weeks)Time in weeks from the date of Complete Response (CR) or Partial Response (PR), whichever occurs earlier, to the date of discontinuation of study. RECIST guidelines:(Response evaluation criteria in solid tumors, version 1.0)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)Population: Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).
Time in weeks from date of first study drug administration to the date of progressive disease according to the RECIST guidelines (Response evaluation in solid tumors, version 1.0), or death due to any cause.
Outcome measures
| Measure |
AZD4877
n=39 Participants
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
|
|---|---|
|
Progression Free Survival (PFS)
|
7.3 Weeks
Interval 0.0 to 44.0
|
SECONDARY outcome
Timeframe: Time from the first administration of study drug to disease progression or death (maximum treatment period of 309 days (44 weeks)Population: Of the 41 participants who received at least one dose of study medication, only 39 were evaluable for response by RECIST (excludes 2 patients who had baseline scans performed more than 28 days before dosing).
Time in weeks from the first administration of study drug to death.
Outcome measures
| Measure |
AZD4877
n=39 Participants
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
|
|---|---|
|
Overall Survival (OS)
|
23.1 Weeks
Interval 1.3 to 48.1
|
Adverse Events
AZD4877
Serious adverse events
| Measure |
AZD4877
n=41 participants at risk
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
2.4%
1/41
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.4%
1/41
|
|
Cardiac disorders
Acute Myocardial Infarction
|
2.4%
1/41
|
|
Cardiac disorders
Cardiac Failure Congestive
|
2.4%
1/41
|
|
Cardiac disorders
Ventricular Arrhythmia
|
2.4%
1/41
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.4%
1/41
|
|
General disorders
Chest Pain
|
2.4%
1/41
|
|
General disorders
Death
|
2.4%
1/41
|
|
General disorders
Fatigue
|
2.4%
1/41
|
|
Infections and infestations
Urinary Tract Infection
|
4.9%
2/41
|
|
Infections and infestations
Infection
|
2.4%
1/41
|
|
Injury, poisoning and procedural complications
Narcotic Intoxication
|
2.4%
1/41
|
|
Metabolism and nutrition disorders
Dehydration
|
4.9%
2/41
|
|
Psychiatric disorders
Mental Status Changes
|
2.4%
1/41
|
|
Renal and urinary disorders
Haematuria
|
2.4%
1/41
|
|
Renal and urinary disorders
Renal Failure Acute
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.4%
1/41
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
2.4%
1/41
|
Other adverse events
| Measure |
AZD4877
n=41 participants at risk
AZD4877 25 mg (Intravenous (IV), 25mg weekly)
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
56.1%
23/41
|
|
Blood and lymphatic system disorders
Anaemia
|
26.8%
11/41
|
|
Blood and lymphatic system disorders
Leukopenia
|
17.1%
7/41
|
|
Gastrointestinal disorders
Nausea
|
26.8%
11/41
|
|
Gastrointestinal disorders
Constipation
|
19.5%
8/41
|
|
Gastrointestinal disorders
Vomiting
|
19.5%
8/41
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.2%
5/41
|
|
Gastrointestinal disorders
Diarrhoea
|
12.2%
5/41
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
7.3%
3/41
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.3%
3/41
|
|
General disorders
Fatigue
|
31.7%
13/41
|
|
General disorders
Pyrexia
|
17.1%
7/41
|
|
General disorders
Asthenia
|
12.2%
5/41
|
|
General disorders
Influenza Like Illness
|
9.8%
4/41
|
|
General disorders
Oedema Peripheral
|
9.8%
4/41
|
|
Infections and infestations
Urinary Tract Infection
|
26.8%
11/41
|
|
Infections and infestations
Oral Candidiasis
|
7.3%
3/41
|
|
Infections and infestations
Weight Decreased
|
12.2%
5/41
|
|
Metabolism and nutrition disorders
Anorexia
|
17.1%
7/41
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
12.2%
5/41
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.3%
3/41
|
|
Musculoskeletal and connective tissue disorders
Groin Pain
|
7.3%
3/41
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
7.3%
3/41
|
|
Nervous system disorders
Headache
|
9.8%
4/41
|
|
Nervous system disorders
Lethargy
|
9.8%
4/41
|
|
Psychiatric disorders
Insomnia
|
12.2%
5/41
|
|
Renal and urinary disorders
Haematuria
|
7.3%
3/41
|
|
Renal and urinary disorders
Pollakiuria
|
7.3%
3/41
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.2%
5/41
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee An Investigator agrees to provide a copy of the publication to AZ for review at least 60 days in advance of submission for publication. Investigators in multicenter (MC) studies agree to postpone MC publications until the earlier of the date of the first AZ-authorized MC publication or a period up to 18 months from study completion at all sites. AZ has the right to request delays: up to 60 days for confidential information, and an additional 90 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER