Condition category
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Contact information



Primary contact

Dr Anjali Zarkar


Contact details

Queen Elizabeth Hospital Birmingham
Cancer Centre
B15 2TH
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number


Study information

Scientific title

Cabazitaxel in platinum pre-treated patients with locally advanced or metastatic transitional cell carcinoma who developed disease progression within 12 months of platinum based chemotherapy


Cab B1

Study hypothesis

The study aims to compare the overall response rate of cabazitaxel treatment versus best supportive care including single agent chemotherapy in patients with locally advanced or metastatic transitional cell carcinoma who developed disease progression within 12 months of platinum based chemotherapy.

Ethics approval

NRES Ethics Committee East Midlands - Leicester, 15/10/2012, ref: 12/EM/0363

Study design

Randomised open-label parallel-group study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet


Transitional cell carcinoma


Cabazitaxel versus Best Supportive Care
Treatment duration: Up to 6 three weekly cycles of chemotherapy (18 weeks)

Intervention type



Not Applicable

Drug names


Primary outcome measure

Overall response rate. Time Frame: Change from baseline at Week 9 and Week 18

Secondary outcome measures

1. Overall survival: Defined as the time interval from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time will be censored at the earlier of the last date the patient is known to be alive and the study cut-off date. Time Frame: From date of randomisation to the date of tumour progression or death (from any cause) (or survival at study cut-off date), whichever came first up to 12 months after the final patient has completed study treatment.
2. Quality of life, assessed using a validated instrument; the EuroQOL (EQ-5D). Time Frame: Change from baseline at Week 6, Week 12, Week 18, Week 21
3. Safety and tolerability: Dose delays and dose reductions, adverse events, laboratory safety data. Time Frame: From date of randomisation up to 30 days after final dose of study medication

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Written informed consent
2. Age ≥ 18
3. Life expectancy ≥ 12 weeks
4. Patients with histology/cytology confirmed Transitional Cell Carcinoma (TCC) including mixed pathology with predominantly TCC, with locally advanced (T4b) or metastatic (lymph node or visceral) TCC arising from bladder or upper urinary tracts
5. Treated patients with incidental prostate cancer (pT2, Gleason ≤ 6) and PSA (Prostate Specific Antigen) ≤ 0.5 ng/mL are eligible
6. Measurable disease as per RECIST Criteria 1.1
7. ECOG Performance Status 0-1
8. Previously received first line platinum based treatment
9. Recurrence within 12 months (by RECIST criteria version 1.1) from last cycle of chemotherapy

Participant type


Age group




Target number of participants

96 (25 patients will be initially recruited and after intermin analysis, a further 71 patients may be recruited)

Participant exclusion criteria

1. Previous therapy with a taxane
2. Pure non TCC histologies
3. Grade II or more peripheral neuropathy
4. Prior surgery, radiation, chemotherapy, or other anti-cancer therapy within 4 weeks prior to enrolment in the study
5. Uncontrolled severe illness or medical condition (including uncontrolled diabetes mellitus)
6. Inadequate organ and bone marrow function as evidenced by:
6.1. Hemoglobin < 9.0 g/dL
6.2. Absolute neutrophil count < 1.5 x 109/L
6.3. Platelet count < 100 x 109/L
6.4. AST/SGOT and/or ALT/SGPT > 2.5 x ULN
6.5. Total bilirubin > 1.0 x ULN
6.6. Serum creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated according to CKD-EPI formula and patients with creatinine clearance ≤ 30 mL/min should be excluded
7. Symptomatic brain metastases or leptomeningeal disease (CT or MRI scan of the brain required only in case of clinical suspicion of central nervous system involvement)
8. History of another neoplasm except non-metastatic melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery, small field radiation or chemotherapy < 5 years prior to randomization
9. History of inflammatory bowel disease, significant bowel obstruction
10. History of hypersensitivity to platinum, gemcitabine, taxanes, Polysorbate-80, or to compounds with similar chemical structures
11. Any of the following events within 6 months prior to randomization: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant arrhythmias (grade 3-4)
12. Concurrent treatment with strong inhibitors of cytochrome P450 3A4 or patients planning to receive these treatments. For patients who were receiving treatment with such agents, a one-week washout period is required prior to randomization
13. Women who are breastfeeding and women of child bearing potential (not postmenopausal (12 months of amenorrhea) or surgically sterile (absence of ovaries and/or uterus)) unless in agreement to use an adequate method of contraception during the treatment period and for 6 months after the last dose of the study drug. Men unless in agreement that they will use effective contraception (and condom to protect against exposure to seminal liquid) whilst participating in the trial and for 6 months after the last dose of study medication

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Queen Elizabeth Hospital Birmingham
B15 2TH
United Kingdom

Sponsor information


University Hospitals Birmingham NHS Foundation Trust (UK)

Sponsor details

c/o Dr Chris Counsell
Queen Elizabeth Hospital Birmingham
B15 2TH
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

Sanofi Aventis (France)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Basic results (scientific)

Publication list

2017 results in

Publication citations

Additional files

Editorial Notes

07/03/2018: Publication reference added. 12/01/2018: No publications found, verifying study status with principal investigator.