Prostate CancerPhase 2NCT01834651
A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases
A Phase 2 study testing Cabozantinib in people with Prostate Cancer, run by Edwin Posadas, MD at 1 site in United States.
Trial summary
This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Cabozantinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Apr 2013to 18 Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- mCRPC that includes visceral disease. Visceral metastatic disease is defined as solid organ infiltration that is not bone or lymph node metastases.
Who cannot join
- Recent history (<6 months) of gastrointestinal hemorrhage requiring blood transfusion.
- Tumor involvement in the intestinal lining which the treating physician deems at risk for perforation with rapid tumor response.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.
Read the detailed description
Cabozantinib (XL184), a multi-targeted tyrosine kinase inhibitor, has demonstrated a powerful clinical phenotype in men with metastatic castrate resistant prostate cancer (mCRPC) both before and after chemotherapy. This phenotype consists of rapid reduction in pain (when present) and improvement in bone scans that may or may not be accompanied by decrease in serum prostate specific antigen (PSA) concentrations. In previous studies of cabozantinib in advanced prostate cancer, patients with visceral disease have been excluded. Hence, this protocol creates a unique opportunity to define the activity of this disease in the population of men with visceral disease - a marker for poorer prognosis in mCRPC.
Primary Objectives:
- To assess the clinical benefit (complete response + partial response + stable disease) of cabozantinib in patients with mCRPC with visceral metastases.
Secondary Objectives:
- To assess the impact of cabozantinib on numbers live circulating tumor cells (CTCs) using NanoVelcro Chips
- To test the feasibility of measuring variation in gene expression in circulating tumor cells (CTCs) in response to therapy.
- To determine if there is an impact of cabozantinib on live circulating tumor cell (CTC) number and patterns of gene expression.
- To measure the impact of cabozantinib on serum HGF (hepatocyte growth factor) and VEGF (vascular endothelial growth factor) levels in men with metastatic, castration-resistant prostate cancer (mCRPC).
- To assess the safety and tolerability of lower doses (i.e. doses below 100 mg daily) of cabozantinib in mCRPC with visceral involvement.
- To collect blood, urine, tissue, and plasma which may be used determine if there are germline genetic variations that correlate with toxicity.
- To pilot correlations between molecular content between circulating tumor cells (CTCs), large oncosomes, and tumor tissue.
- Conditions
- Prostate Cancer
- Being tested
- Cabozantinib
- Keywords
- liver metastasis, lung metastasis, metastatic castrate-resistant, prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabozantinibDrug
Also called XL184
Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.
| Study group | Role | What they receive |
|---|---|---|
| Treatment (cabozantinib) | Experimental | Cabozantinib 60mg orally daily until disease progression Receives: Drug: Cabozantinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Benefit Rate From Cabozantinib (XL184)
Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria.
Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) >=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease.
Measured: Baseline to 12 weeks after starting therapy
Secondary outcomes (5)
Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib
Change in number of CTC from baseline at 12 weeks
Measured: Baseline and 12 weeks
Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells
This is to provide a measure of feasibility using NanoVelcro to measure RNA in circulating tumor cells (CTC)
Measured: 12 weeks
Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration
Mean change from baseline in levels of HGF and VEGF
Measured: 12 weeks
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4)
Each cycle is 28 days. Safety and tolerability was defined as related grade 3-4 AEs of doses of cabozantinib below 100 mg daily using common terminology criteria for adverse events (CTCAE)
Measured: Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.
Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death
This is a feasibility outcome to assess ability to measure protein content in large oncosomes in this population.
Measured: From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study start30 Apr 2013
- Primary completion18 Jul 2016
- Study completion18 Jul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edwin Posadas, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edwin Posadas, MD, Cedars-Sinai Medical Center
- Investigators
- Edwin Posadas, MD FACP, Principal investigator, Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834651
- Sponsor's protocol ID
- XL184-IST20
- Status last verified
- Aug 2017
- First submitted
- 1 Apr 2013
- Last updated
- 27 Sep 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Cabozantinib (XL184) Therapy in Castrate Resistant Prostate Cancer (CRPC) With Visceral Metastases
- ClinicalTrials.gov ID
- NCT01834651
- Acronym / sponsor ID
- XL184-IST20
- Conditions
- Prostate Cancer
- Keywords
- liver metastasis, lung metastasis, metastatic castrate-resistant, prostate cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Edwin Posadas, MDUniversity, hospital or other
- Study start
- 30 Apr 2013 (actual)
- Primary completion
- 18 Jul 2016 (actual)
- Study completion
- 18 Jul 2016 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Posted 27 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to measure the clinical benefit associated with cabozantinib (XL184) in men who have prostate cancer that has spread to visceral organs (organs other than bone or lymph nodes) and no longer responds to initial hormonal (castration) therapy. This type of prostate cancer is called metastatic, castrate-resistant prostate cancer.
Detailed description
Cabozantinib (XL184), a multi-targeted tyrosine kinase inhibitor, has demonstrated a powerful clinical phenotype in men with metastatic castrate resistant prostate cancer (mCRPC) both before and after chemotherapy. This phenotype consists of rapid reduction in pain (when present) and improvement in bone scans that may or may not be accompanied by decrease in serum prostate specific antigen (PSA) concentrations. In previous studies of cabozantinib in advanced prostate cancer, patients with visceral disease have been excluded. Hence, this protocol creates a unique opportunity to define the activity of this disease in the population of men with visceral disease - a marker for poorer prognosis in mCRPC.
Primary Objectives:
- To assess the clinical benefit (complete response + partial response + stable disease) of cabozantinib in patients with mCRPC with visceral metastases.
Secondary Objectives:
- To assess the impact of cabozantinib on numbers live circulating tumor cells (CTCs) using NanoVelcro Chips
- To test the feasibility of measuring variation in gene expression in circulating tumor cells (CTCs) in response to therapy.
- To determine if there is an impact of cabozantinib on live circulating tumor cell (CTC) number and patterns of gene expression.
- To measure the impact of cabozantinib on serum HGF (hepatocyte growth factor) and VEGF (vascular endothelial growth factor) levels in men with metastatic, castration-resistant prostate cancer (mCRPC).
- To assess the safety and tolerability of lower doses (i.e. doses below 100 mg daily) of cabozantinib in mCRPC with visceral involvement.
- To collect blood, urine, tissue, and plasma which may be used determine if there are germline genetic variations that correlate with toxicity.
- To pilot correlations between molecular content between circulating tumor cells (CTCs), large oncosomes, and tumor tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (cabozantinib) | Experimental | Drug: CabozantinibCabozantinib 60mg orally daily until disease progression |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- mCRPC that includes visceral disease. Visceral metastatic disease is defined as solid organ infiltration that is not bone or lymph node metastases.
Key exclusion criteria (2 listed)
- Recent history (<6 months) of gastrointestinal hemorrhage requiring blood transfusion.
- Tumor involvement in the intestinal lining which the treating physician deems at risk for perforation with rapid tumor response.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CabozantinibAlso: XL184Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression. | Drug | Treatment (cabozantinib) |
Primary outcome
Clinical Benefit Rate From Cabozantinib (XL184)
Time frame: Baseline to 12 weeks after starting therapy
Clinical benefit rate is defined as the combination of complete response, partial response, and stable disease as defined by modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by CT imaging and Prostate Cancer Working Group 2 (PCWG2) criteria. Complete response (CR) defined as disappearance of all target lesions; Partial response (PR) >=30% decrease in som of diameters of target lesions (taking as reference the baseline), and stable disease, neither sufficient shrinkage to qualify for PR nor increase to qualify for progressive disease.
5 secondary outcomes
Change in Number of Circulating Tumor Cells (CTC) in Response to Cabozantinib
Time frame: Baseline and 12 weeks
Number of Patients With NanoVelcro Appropriate for RNA in Circulating Tumor Cells
Time frame: 12 weeks
Change in Levels of Serum Hepatocyte Growth Factor (HGF) and Vascular Endothelial Growth Factor (VEGF) Concentration
Time frame: 12 weeks
Number of Participants With Grade 3/4 Adverse Events Related to Cabozantinib as Assessed Using CTCAE (v.4)
Time frame: Every 2 weeks for first 3 Cycles and every 4 weeks thereafter for an expected average of 28 weeks.
Number of Patients With Evaluable Protein Content of Large Oncosomes From Baseline to First Documented Progression or Date of Death
Time frame: From baseline until the date of first documented progression or date of death from any cause, whichever comes first, assessed for an expected average of 28 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin Posadas, MD FACP principal investigator
Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cabozantinib in people with Prostate Cancer, run by Edwin Posadas, MD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Benefit Rate From Cabozantinib (XL184) (time frame: Baseline to 12 weeks after starting therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2017.