OPEN FOR RECRUITMENT

BREAST CANCER

ODONATE ODO-TE-B301 STUDY

A Multinational, Multicenter, Randomized, Phase 3 Study of Tesetaxel plus a Reduced Dose of Capecitabine versus Capecitabine Alone in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Previously Treated with a Taxane. Recruitment is ongoing – 1 participant is currently ongoing on treatment.

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  • ATOSSA AG-1001-AU-02 Study: An Open Label, Pharmacodynamic Study of (Z)-endoxifen in Patients with Invasive Breast Cancer Prior to Undergoing Mastectomy or Lumpectomy

Recruitment is ongoing.

  1. BI1280-0022 Xenera-1: A multi-centre, double-blind, placebo-controlled, randomised phase II trial to compare efficacy of xentuzumab in combination with everolimus and exemestane versus everolimus and exemestane in post-menopausal women with HR+ / HER2-metastatic breast cancer and non-visceral disease.

2 study arms: xentuzumab/everolimus/exemestane or placebo/everolimus/exemestane in post-menopausal patients with HR+/ HER2- advanced or metastatic breast cancer and non-visceral disease.

Study Drug: Xentuzumab (BI 836845) is a humanised immunoglobuline isotype G1 (IgG1) monoclonal

antibody (mAb) that binds to and neutralises the function of human insulin-like growth

factor-1 and 2 (IGF-1, IGF-2).

Recruitment is ongoing. 1 participant is on treatment.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03659136?term=Xenera-1&rank=1

  1. Arcus AB928CSP0002: A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Breast or Gynecologic Malignancies.

Dose-escalation Phase: escalating doses of AB928 (75 mg [starting dose, Cohort 1], 150 mg [Cohort 2], and 200 mg [Cohort 3]) administered orally once daily (QD) in combination with a standard regimen of Pegylated Liposomal Doxorubicin (40 mg/m2 intravenously [IV] every 4 weeks [Q4W]). TNBC (estrogen receptor-negative, progesterone-negative, and human epidermal growth factor receptor-2-negative) or ovarian cancer that is metastatic, advanced or recurrent with progression for which no alternative or curative therapy exists – up to 5 lines of prior therapies for advanced/recurrent and progressive disease (unlimited hormonal therapies allowed).

Dose-expansion Phase: the dose of AB928 to be used in the dose-expansion phase will be determined based on the findings from the dose-escalation phase of this study. Study population: TNBC that is metastatic, or recurrent with progression for which no alternative or curative therapy exists or the physician and participant consider this option to be appropriate and is documented in the medical record or ovarian cancer that is platinum resistant (up to 2 prior therapies for metastatic, recurrent and progressive disease (unlimited hormonal therapies are allowed). Participants with ovarian cancer may have received 2 other therapies after progression on their initial platinum-based regimen.

Study Drug: AB928 is a low molecular weight, orally bioavailable, selective dual antagonist of the adenosine 2a receptor (A2aR) and the adenosine 2b receptor (A2bR).

SIV conducted on 07 Feb 2019. First 3 slots have been allocated. 2 slots have been allocated for our site in the next cohort. Next slot will be available 11 March 2019.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03719326?term=AB928CSP0002&rank=1

  1. WO39391 IMpassion030: A Phase III, Multicenter, Randomized, Open-label Study Comparing

ATEZOLIZUMAB (Anti PD-L1 Antibody) in Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy vs Chemotherapy Alone in Patients With Operable Triple-Negative Breast Cancer

Arm A: Atezolizumab and Chemotherapy – Atezo (840 mg) administered via IV Q2W in combination with chemotherapy (as described below), followed by atezolizumab maintenance therapy

(1200 mg IV infusion every 3 weeks [Q3W]) to complete a total duration of 1 year of

atezolizumab treatment from the first administration of atezolizumab.

– Chemotherapy: paclitaxel (80 mg/m2) administered via IV infusion weekly (QW) for

12 weeks followed by dose-dense doxorubicin (60 mg/m2) or dose-dense epirubicin

(90 mg/m2) IV (investigator’s choice) cyclophosphamide (600 mg/m2) IV repeated

Q2W for 4 doses.

Arm B: Chemotherapy alone

Study Has been approved by HREC – SIV is planned in March 2019

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03498716?term=WO39391&rank=1

  1. Daiichi Sankyo DS8201-A-U301 Study: A Phase 3, multicenter, randomized, open-label, active-controlled study of DS-8201a, an anti-HER2-antibody drug conjugate, versus treatment of investigator’s choice for HER2-positive, unresectable and/or metastatic breast cancer subjects pretreated with prior standard of care HER2 therapies, including T-DM1.

Recruitment is now opened – SIV was conducted on 28 February 2019.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03523585?term=DS8201-A-U301&rank=1

  1. Daiichi Sankyo DS8201-A-U302 Study: A Phase 3, multicenter, randomized, open-label, active-controlled study of DS-8201a, an anti-HER2-antibody drug conjugate, versus ado-trastuzumab emtansine (T-DM1) for HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.

Recruitment is now opened – SIV was conducted on 28 February 2019.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03529110?term=DS8201-A-U302&rank=1

GASTRO INTESTINAL TUMOURS

  1. Boston CanStem303C CRC: A Phase III Study of BBI-608 in combination with 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in Adult Patients with Previously Treated Metastatic Colorectal Cancer (CRC)

Recruitment closed as of 05 March 2019 – 1 participant is ongoing on treatment.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT02753127?term=CanStem303C&rank=1

  1. Arcus AB928CSP0003: A Phase 1/1b Study to Evaluate the Safety and Tolerability of Immunotherapy Combinations in Participants with Gastrointestinal Malignancies.

Dose-escalation Phase – AB928 orally QD at escalating doses (75 mg [starting dose, Cohort 1], 150 mg [Cohort 2], and 200 mg [Cohort 3]) in combination with a standard mFOLFOX chemotherapy regimen (oxaliplatin 85 mg/m2 IV Q2W, leucovorin 400 mg/m2 IV Q2W, and 5-FU 400 mg/m2 IV bolus + 2400 mg/m2 [continuous 46-hour infusions on Day 1 and Day 2]). Next slot will be available mid March 2019

Dose-expansion Phase – AB928 orally QD at the recommended Phase 2 dose in combination with the standard mFOLFOX chemotherapy regimen (same as above).

The dose escalation phase (up to 5 lines of prior therapies) and the dose expansion phase (up to 2 lines of prior therapies, no prior oxaliplatin, except oxaliplatin-based therapy in the adjuvant setting if completed ≥ 6 months prior) in both histologically confirmed gastroesophageal cancer and colorectal cancer.

Study Drug – AB928 is a low molecular weight, orally bioavailable, selective dual antagonist of the adenosine 2a receptor (A2aR) and the adenosine 2b receptor (A2bR).

SIV conducted 07 Jan 2019. Site is now open for recruitment.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03720678?term=AB928CSP0003&rank=1

  1. SOLSTICE study (CL3-95005-006): An open-label, randomised, phase III Study cOmparing trifLuridine/tipiracil (S 95005) in combination with bevacizumab to capecitabine in combination with bevacizumab in firST-line treatment of patients with metastatIC colorectal cancer who are not candidatE for intensive therapy

Study has been delayed by the Sponsor – to be resubmitted to HREC in Feb 2019. Awaiting all required documents for resubmission.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03869892?term=CL3-95005-006&rank=1

COLORECTAL CANCER

PHASE II: PROTOCOL NUMBER AGITG AG1013GST

A randomised phase II trial of imatinib alternating with regorafenib compared to imatinib alone for the first line treatment of advanced gastrointestinal stromal tumour (GIST).

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PHASE III: BOSTON CANSTEM303C CRC

A phase III study of BBI-608 in combination with 5-Fluorouracil, Leucovorin, Irinotecan (FOLFIRI) in adult patients with previously Treated Metastatic Colorectal Cancer (CRC)

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GASTRIC AND GASTRO-ESOPHAGEAL JUNCTION CANCER

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LUNG CANCER

  1. Protocol No. BPI-2358-103 – Dublin 3 Study (Beyond Springs) Randomized Blinded Phase 3 Assessment of Second-or Third Line Chemotherapy with Docetaxel + Plinabulin Compared to Docetaxel + Placebo in Patients with Advanced Non-Small Cell Lung Cancer with at Least 1 Large Lung Lesion

Recruitment is ongoing.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT02504489?term=BPI-2358-103&rank=1

  1. NIVORAD: A Randomised Phase 2 Trial of Nivolumab and Stereotactic Ablative Body Radiotherapy in Advanced Non-Small Cell Lung Cancer Progressing after First or Second Line Chemotherapy

Recruitment is ongoing.

Australian New Zealand Clinical Trials Registry link:

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ACTRN12616000352404&isBasic=True

  1. RESILIENT – IPSEN MM-398: A Randomized, Open Label Phase 3 Study of Irinotecan Liposome Injection (ONIVYDE®) versus Topotecan in Patients with Small Cell Lung Cancer Who Have Progressed on or after Platinum-based First-Line Therapy

Recruitment is ongoing. Enrolment into Part 1 is now closed – Cohort 4 (Dose Expansion)- 70 mg/m2 – closed on 27 February 2019. Awaiting SMC review on 14 Mar 2019.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03088813?term=MM-398&rank=7

  1. TAKEDA Brigatinib-2002 Study: Brigatinib in Patients With Anaplastic Lymphoma Kinase-Positive (ALK+), Advanced Non–Small-Cell Lung Cancer (NSCLC) Progressed on Alectinib or Ceritinib

Recruitment is ongoing.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03535740?term=Brigatinib-2002&rank=1

MESOTHELIOMA

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LYMPHOMA

  1. Protocol No. HMPL-523 Hutchison Phase I: A Phase I, open-label, dose-escalation study of the safety and pharmacokinetics of HMPL-523 in patients with relapsed or refractory Hematologic Malignancies

Recruitment is ongoing. Currently Dose Expansion phase of the study is open.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT02503033?term=HMPL-523&rank=5

MYELODYSPLASTIC SYNDROME (MDS)

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PANCREATIC CANCER

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PROSTATE CANCER

  1. Protocol CO-338-052 (TRITON2): A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency.

Recruitment is ongoing. Currently 3 patients are on treatment and 2 in screening. Prescreening via Foundation Medicine testing is ongoing.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT02952534?term=TRITON+2&rank=1

  1. Protocol CO-338-063 (TRITON3): A Multicenter, Randomized, Open-label Phase 3 Study of Rucaparib versus Physician’s Choice of Therapy for Patients with Metastatic Castration-resistant Prostate Cancer Associated with Homologous Recombination Deficiency.

Recruitment is ongoing. Prescreening via Foundation Medicine testing is ongoing.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT02975934?term=TRITON+3&rank=1

UROTHELIAL CANCER

  1. Protocol No.: 42756493BLC3001 (THOR) Janssen: A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Recruitment is ongoing – 1 participant is currently on treatment.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03390504?term=42756493BLC3001&rank=1

  1. MK-3475-057: A Phase II Clinical Trial to Study the Efficacy and Safety of Pembrolizumab (MK-3475) in Subjects with High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Bacillus Calmette-Guerin (BCG) Therapy.

Study revised consent forms have been submitted to the sponsor for approval prior to the HREC submission (there has been a delay for more than 2 weeks and approval of the submitted documents) – estimated SIV mid March 2019.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT02625961?term=MK-3475-057&rank=1

RENAL CANCER

SOLID TUMOURS

  1. AbbVie M15-862: A Multicenter, Phase 1, Open-Label, Dose-Escalation Study of ABBV-927, an Immunotherapy, in Subjects with Advanced Solid Tumors

Recruitment is ongoing. 1 patient is in screening for HNSCC Arm A

Dose Expansion

  • IV Dose Expansion Monotherapy – HNSCC – 12 open slots – open competitive enrollment

NSCLC – 11 open slots – open competitive enrolment

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT02988960?term=M15-862&rank=1

  1. EnGeneIC ENG8 Designer EDV: A Phase 1 Study of Anti-Human EGFR (Vectibix Sequence) Targeted EDVTMs Carrying the Cytotoxic Drug PNU-159682 (EGFR(V)-EDV-PNU) with Concurrent Non-Targeted EDVs Carrying an Immunomodulatory Adjuvant (EDV-40mer) in Subjects with Advanced Solid Tumours who have No Curative Treatment Options.

Recruitment is ongoing. 2 patients are currently receiving treatment.

 Australian New Zealand Clinical Trials Registry link:

https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=372060&isReview=true

  1. KN046-AUS-001: An Open-Label, Multicenter, Dose-Escalation Phase I Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of KN046 in Subjects with Advanced Solid Tumors.

Recruitment is ongoing – 6 patient is currently on treatment.

Expansion Cohort (3mg/kg) is now open for recruitment (competitive recruitment) – PSEHOG has 4 potential patients waiting to be enrolled.

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03529526?term=KN046&rank=2

  1. BMS CA030001: A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors.

Study drug: BMS-986249 is an anti-CTLA-4 Probody mAb made by the addition of 44

amino acids to the N-terminus of both light chains of the human anti-CTLA-4 Ab, ipilimumab.

Study Design:

  • Part 1A, the BMS-986249 Monotherapy Dose Escalation, will escalate the dose of

BMS-986249 to determine a safe and efficacious dose (closed for recruitment)

  • Part 1B, the Safety Evaluation of Combination Doses of BMS-986249 with nivolumab (open for recruitment)
  • Part 2: dose expansion (combination therapy)

Recruitment is ongoing. SIV was conducted on 14 February 2019. Next slot available – mid April 2019

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03369223?term=NCT03369223&rank=1

  1. EnGeneIC Carolyn Trial/ENG 9: A Phase I/IIa Study of EGFR-Targeted EDVTMs Carrying the Cytotoxic Drug PNU-159682 (E-EDV-D682) with Concurrent Immunomodulatory Adjuvant Non-Targeted EDVs carrying α-galactosyl ceramide (EDV-GC) in (i) Cohort 1, Subjects with Advanced Pancreatic Cancer and (ii) Cohort 2, Subjects with other EGFR Expressing Solid Tumours, who have Failed First or Second-line Therapy or where other Standard Therapies are not Appropriate

SIV occurred on 11 February 2019. Opened for recruitment. One potential patient is waiting to be consented (Ronald Pickersgill) + David Gordon is planned to be transferred from ENG8 Study.

Australian New Zealand Clinical Trials Registry link:

http://www.anzctr.org.au/TrialSearch.aspx?searchTxt=ENG9&isBasic=True

  1. CBT-501-01: A phase 1 multicenter, dose escalation study of CBT-501 in subjects with advanced or relapsed/recurrent solid tumors

Study Drug: CBT-501 (GB-226; genolimzumab) is a humanized IgG4 monoclonal antibody against Programmed Death-1 (PD-1) receptor.

Study Design: In the Dose Escalation segment (three dose levels are planned: 1, 3, and 10 mg/kg), each treatment cycle is comprised of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle.

In the Cohort Extension (≥ two malignancies will be determined by the SRC upon review of the data), the treatment cycle will consist of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle and/or 1 dose of study drug administered on Day 1 of a 21-day cycle.

Recruitment is ongoing. SIV on 21 February 2019. Next slot is available

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03053466?term=CBT-501&rank=1

  1. Five Prime FPA150-001: A Phase 1a/1b Study of FPA150, an Anti-B7-H4 Antibody, in Patients with Advanced Solid Tumors.

Study Drug: FPA150 is a recombinant, afucosylated, fully human immunoglobulin G1 (IgG1) kappa

monoclonal antibody directed against the transmembrane protein B7 homolog 4 (B7-H4) – checkpoint inhibitor.

Study Design:

Phase 1a Dose Escalation: In Phase 1a Dose Escalation, cohorts are planned at doses from 0.01 to 20 mg/kg

Phase 1a Dose Exploration: Phase 1a may include a dose exploration cohort that may enroll

beyond 3 patients (up to 10 additional patients across all dose levels)

Phase 1b Dose Expansion: to be determined based on the data from the Phase 1a part of the study. Phase 1b will initially consist of cohorts of up to 30 patients each in the following 4 tumor types with B7-H4 expression levels determined by IHC:

  • Cohort 1b1: Breast cancer
  • Cohort 1b2: Ovarian cancer
  • Cohort 1b3: Endometrial cancer
  • Cohort 1b4: Urothelial cancer

Based on emerging clinical and translational data from the study, cohorts for additional tumor

types may be opened during the trial (not to exceed 30 patients in any individual cohort).

 SIV will be booked mid March 2019. Availability of the slots will be discussed at the time of the SIV

Clinicaltrials.gov link:

https://clinicaltrials.gov/ct2/show/NCT03514121?term=FPA150-001&rank=1

  1. CStone CS3002-101: A Phase I, Open-Label, Multiple-Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Activities of CS3002, a CDK4/6 Inhibitor, in Subjects with Advanced Solid Tumors.

Study Drug: CS3002, a small-molecule inhibitor targeting cyclin-dependent kinases 4 and 6 (CDK4/6)

Study Design:

Part 1 – Dose Escalation: Six cohorts dosed at 20, 50, 100, 200, 350 and 500 mg, QD are planned

Part 2 – Dose Expamsion: approximately 10 additional subjects will be enrolled during dose expansion (Part 2) at MTD/RP2D cohort

Site selected by the sponsor on 04 Feb 2019 awaiting HREC submission and regulatory documents from the sponsor.

Clinicaltrials.gov link:

ONGOING (NOT RECRUITING)

BREAST CANCER

PHASE III: EMBRACA

A phase 3, open-label, randomized, parallel, 2-arm, multi-center study of talazoparib (BMN 673) versus physician’s choice in germline BRCA mutation subjects with locally advanced and/or metastatic breast cancer, who have received prior chemotherapy regimens for metastatic disease.

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PHASE III: PROTOCOL WO29522 IMPASSION130

A phase III, multicenter, randomized, placebo-controlled study of MPDL3280A (anti−PD-L1 antibody) in combination with nab-paclitaxel compared with placebo with nab-paclitaxel for patients with previously untreated metastatic triple-negative breast cancer.

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PHASE II EXTENSION STUDY : PROTOCOL TDM4529G/BO25430

This is a global, multicenter, open-label extension study. Patients receiving single-agent T-DM1 or combination T-DM1 administered in combination with paclitaxel or with pertuzumab ± paclitaxel in a Genentech/Roche-sponsored study who completed the parent study or who continue to receive study drug(s) at the time of the parent study closure are eligible for continued treatment on this protocol.

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PHASE II: PROTOCOL GO29689

A phase II, open-label, randomized study of GDC-0810 versus fulvestrant in postmenopausal women with advanced or metastatic ER+ /HER2 − breast cancer resistant to aromatase inhibitor therapy.

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GASTRIC AND GASTRO-ESOPHAGEAL JUNCTION CANCER

PHASE III: PROTOCOL NUMBER GS-US-296-1080

A phase 3 randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of GS-5745 combined with mFOLFOX6 as first line treatment in patients with advanced gastric or gastroesophageal junction adenocarcinoma.

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PHASE III: PROTOCOL NUMBER BBI608-336

A phase III randomized, double-blind, placebo-controlled clinical trial of BBI608 plus weekly paclitaxel vs. placebo plus weekly paclitaxel in adult patients with advanced, previously treated gastric and gastro-esophageal junction adenocarcinoma.

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LUNG CANCER

PHASE III: PROTOCOL D5164C00001 (ADAURA)

A phase III, double-blind, randomized, placebo-controlled multi-centre, study to assess the efficacy and safety of AZD9291 versus placebo in patients with epidermal growth factor receptor mutation positive stage IB-IIA non-small cell lung carcinoma, following complete tumour resection with or without adjuvant chemotherapy.

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Phase II: Protocol Number HM-EMSI-202

A single-arm, open-label, phase 2 study evaluating the efficacy, safety and pharmacokinetics of HM61713 in patients with T790M-positive non-small cell lung cancer (NSCLC) after treatment with an epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI)

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PHASE II: AVEO-AV-299-14-206

A phase 2, multicenter, randomized, double-blind study of ficlatuzumab plus erlotinib versus placebo plus erlotinib in subjects who have previously untreated metastatic, EGFR-mutated non-small cell lung cancer (NSCLC) and BDX004 Positive Label.

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PHASE III: PROTOCOL NUMBER GO29438 (IMPOWER)

A phase III, open-label, randomized study of atezolizumab (mpdl3280a, anti−pd-l1 antibody) in combination with carboplatin or cisplatin+pemetrexed compared with carboplatin or cisplatin+pemetrexed in patients who are chemotherapy-naive and have stage iv non-squamous non−small cell lung cancer.

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COLORECTAL CANCER

PHASE III: PROTOCOL NUMBER GO30182

A phase III, open-label, multicentre, three-arm, randomized study to investigate the efficacy and safety of cobimetinib plus atezolizumab and atezolizumab monotherapy vs. regorafenib in patients with previously treated unresectable locally advanced or metastatic colorectal cancer.

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PROSTATE CANCER

PHASE III: ENZAMET ANZUP1304

A randomized phase 3 trial of enzalutamide in first line androgen deprivation therapy for metastatic prostate cancer.

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Additional Information

UROTHELIAL CANCER

PHASE II: BL.12

A multicentre randomized phase II trial comparing nab-paclitaxel to paclitaxel in patients with advanced urothelial cancer progressing on or after a platinum containing regimen.

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