ANZUP - Non-clear Cell Post Immunotherapy CABozantinib (UNICAB) (UNICAB)
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|ClinicalTrials.gov Identifier: NCT03685448|
Recruitment Status : Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : November 14, 2018
Renal cell carcinoma (RCC) is the 9th most common cancer in Australia, the 10th most common cancer in Western populations.~75% of kidney cancers are clear-cell renal cell carcinomas (ccRCC). Many patients present with advanced or unresectable disease at diagnosis and a number of treatments are now available for metastatic ccRCC included vascular endothelial growth factor receptor tyrosine kinase inhibitors (VEGFR TKIs), mTOR inhibitors, and cytokines. More recently first line use of immunotherapy demonstrated improved survival with checkpoint inhibitors. While many patients benefit from first-line treatment, progression is inevitable and these treatments remain on the whole palliative. Second-line VEGFR TKIs, mTOR inhibitors and immunotherapy have some benefit but in a smaller increment than first-line treatment.
While ~75% of kidney cancers are the clear-cell variant, ~25% of kidney cancers are non-clear cell histology (nccRCC) and include papillary, chromophobe, sarcomatoid, collecting duct carcinoma, Xp11 translocation carcinoma and unclassified. Patients with non-ccRCC have significantly lower response rates and poorer median progression-free survival and overall survival than those with ccRCC. Non clear cell histologies have largely been excluded from large phase III randomised clinical trials and therefore the optimal treatment and sequencing of therapies for these patients remains unclear.
Despite recent unprecedented advances in treatment, there continues to be an unmet need to improve outcomes for patients with previously untreated, unresectable or metastatic renal cell carcinoma. This is particularly relevant in non-clear cell RCC. Because it is a rarer subtype of metastatic renal cell carcinoma, it is more challenging to study, and treatment efficacy data is sparse.
The research project is testing a new treatment for participants with locally advanced or metastatic non-clear cell kidney cancer. The new treatment involves a drug called Cabozantinib (also known as Cabometyx). This drug has been used previously in many cancers, including clear cell kidney cancer and thyroid cancer.
The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of Cabozantinib. Cabozantinib is a anti-cancer drug that works by blocking cancer cell growth. It blocks particular proteins called protein kinases on cancer cells. Protein kinases encourage the cancer to grow. Cabozantinib is called a multi kinase inhibitor because it blocks a number of these proteins. How well cabozantinib works in cancer of the kidney will be tested by measuring the change in size of your tumours that are seen on CT scans.
Cabozantinib is approved to treat clear cell kidney cancer and thyroid cancer in Australia. It has not been tested in people with non-clear cell kidney cancer.
About 48 participants with non-clear cell kidney cancer are expected to participate in this study, from Australia. Even though this study may be suitable for you, it is possible that you may not be enrolled in this study.
This research study has been initiated by Dr. David Pook, is being conducted in collaboration with the Centre for Biostatistics and Clinical Trials (BaCT) and sponsored in Australia by the Australian and New Zealand Urogenital and Prostate (ANZUP) Cancer Trials Group Pty Ltd. Ipsen is supplying
|Condition or disease||Intervention/treatment||Phase|
|Renal Cell Carcinoma Papillary Renal Cell Carcinoma Type 1 Papillary Renal Cell Carcinoma Type 2 Chromophobe Renal Cell Carcinoma Sarcomatoid Renal Cell Carcinoma Xp11.2 Translocation-Related Renal Cell Carcinoma||Drug: Cabozantinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II of Single Agent Cabozantinib in Patients With Locally Advanced or Metastatic Non-clear Cell Renal Cell Carcinoma Post Immunotherapy or Who Are Unsuitable for Immunotherapy (ANZUP1802)|
|Estimated Study Start Date :||January 30, 2019|
|Estimated Primary Completion Date :||January 30, 2022|
|Estimated Study Completion Date :||January 30, 2024|
Experimental: Experimental: Cabozantonib
Cabozantinib 60 mg/day, continuous dosing, taken orally.
The 20 mg cabozantinib drug product is a film-coated, white, round, immediate-release tablet. Cabozantinib should not be stored above 25°C (77°F).
Other Name: Cabometyx
- The objective response rate (ORR), as assessed by RECIST 1.1. [ Time Frame: Through study completion, on average 2 years. ]This is defined as the proportion of participants in the analysis set with a confirmed complete response (CR) or partial response (PR) divided by the number of participants in the analysis set.
- The number of participants with adverse events that are related to study drug, as assessed and graded by CTCAE v5.0. [ Time Frame: From time of patient registration, until 30 days after the last dose of treatment. ]
- Progression-free survival (PFS), as assessed by RECIST1.1. [ Time Frame: Through study completion, on average 2 years. ]
- The number of patients alive at the end of the study, as assessed by date of death. Overall survival (OS) is defined as the time between the date of registration to part 1 of the study and the date of death due to any cause. [ Time Frame: Through study completion, on average 5 years. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03685448
|Contact: Laura Galletta, BSc||+ 61 8559 firstname.lastname@example.org|
|Contact: Simran Chawla||+61 2 8036 email@example.com|
|Australia, New South Wales|
|Border Medical Oncology Research Unit / The Border Cancer Hospital||Not yet recruiting|
|Albury, New South Wales, Australia, 2460|
|Contact: Craig Underhill firstname.lastname@example.org|
|Contact: Jacqui McBurnie +61 2 6064 1508 email@example.com|
|Macquarie University Hospital||Not yet recruiting|
|Macquarie Park, New South Wales, Australia, 2109|
|Contact: Howard Gurney firstname.lastname@example.org|
|Contact: Radhika Butala +61 2 9812 3561 email@example.com|
|Australia, South Australia|
|Flinders Medical Centre||Not yet recruiting|
|Bedford Park, South Australia, Australia, 5042|
|Contact: Ganessan Kichenadasse firstname.lastname@example.org|
|Contact: Alison Richards Alison.email@example.com|
|Adelaide Cancer Centre / Ashford Cancer Centre Research / Cancer Care SA|
|Kurralta Park, South Australia, Australia, 5037|
|Box Hill Hospital - Eastern Health||Not yet recruiting|
|Box Hill, Victoria, Australia, 3128|
|Contact: Ian Davis firstname.lastname@example.org|
|Contact: Lauren Mitchell +61 3 9094 9544 email@example.com|
|Principal Investigator:||David Pook, MBBS FRACPMD||Australian & New Zealand Urogenital & Prostate Cancer Trials Group|