Metastatic Castration Resistant Prostate CancerPhase 2ConCabNCT01541007
A Study Looking at Novel Scheduling of Cabazitaxel for Patients With Metastatic Prostate Cancer
A Phase 2 study testing Cabazitaxel and weekly cabazitaxel in people with Metastatic Castration Resistant Prostate Cancer, run by Jeffrey Yachnin M.D., PhD. at 1 site in Sweden.
Trial summary
Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Metastatic Castration Resistant Prostate Cancer
- What is being tested?
- Cabazitaxel and weekly cabazitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSweden
- Study dates
- Apr 2012to Oct 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Histological confirmed prostate cancer
- Macroscopic metastatic disease
- Prior treatment with Docetaxel
- Castration resistant disease defined as:Serum testosterone (< 0.5 ng/ml) and:
- Increase in measurable disease (RECIST 1.1, see appendix 10) or
- For non-measurable disease, the appearance of at least one new lesion on nuclear scintigraphy) or
- A rising PSA from the previous reference value on 2 consecutive occasions at least one week apart
- Written informed consent
Who cannot join
- Less than 21 days since prior treatment with chemotherapy
- Less than 14 days since radiotherapy or surgery to the start of cabazitaxel - Less than 4 weeks after stopping endocrine therapies including antiandrogen, abiraterone or other new agents.
- Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic radiotherapy is not an exclusion criteria)
- Persistent adverse events from previous cancer therapies > grade 1 (CTCAE - Version 4.0) with the exception of alopecia. (With respect to peripheral neuropathy and nail changes grade 2 is acceptable)
- ECOG performance status > 1
- Known CNS malignancy
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- Within 6 months of randomization:
- myocardial infarction,
- unstable angina,
- angioplasty,
- bypass surgery,
- stroke,
- TIA, or
- congestive heart failure NYHA class III or IV
- Within 3 months prior to randomization:
- treatment resistant peptic ulcer disease,
- infectious or inflammatory bowel disease,
- pulmonary embolism
- Any severe acute or chronic medical condition that places the patient at increased risk of serious toxicity or interferes with the interpretation of study results
- History of hypersensitivity to docetaxel or polysorbate 80
- Inadequate organ and bone marrow function as evidenced by:
- Hemoglobin < 9.0 g/dL
- Absolute neutrophil count < 1.5 x 109/L,
- Platelet count < 100 x 109/L,
- AST/SGOT and/or ALT/SGPT > 1.5 x ULN;
- Total bilirubin > 1.0 x ULN,
- 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 < 60 mL/min should be excluded (http://mdrd.com/ for on-line calculation)
- Concurrent or planned treatment with potent inhibitors or inducers of cytochrome P450 3A4/5. A one week wash out period is necessary for patients who are already on these treatments.
- Patients with reproductive potential not implementing accepted and effective method of contraception.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Deapartment of Oncology Karolinska University Hospital
Stockholm, 171 76
About this study
Official title: A Randomized, Open Label, Multicenter, Phase II Trial Comparing The Conventional 3 Weekly Schedule Of Cabazitaxel With A Weekly Regimen In Patients With Metastatic Castration Resistant Prostate Cancer
Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost one in 4 patients treated with Cabazitaxel in this study required dose reductions or dose delays or stopped treatment due to toxicity. ConCab examines another scheduling for cabazitaxel to see if we can improve tolerability so that patients will receive a higher percentage of the treatment as planned.
Read the detailed description
ConCab compares the standard treatment of cabazitaxel 25 mg/m2 every three weeks with an experimental scheduling of 10 mg/m2 for 5 consecutive weeks of a 6 week cycle. In both study arms the planned cumulative dose of cabazitaxel at week 18 is 150 mg/m2. Our study aims to evaluate differences in the total received dose in relation to the planned dose as a measure of which of the 2 treatment schedules is superior.
- Being tested
- Cabazitaxel, weekly cabazitaxel
- Keywords
- Prostate Cancer, Metastatic, Castration Resistant
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CabazitaxelDrug
25 mg/m2 every three weeks
weekly cabazitaxelDrug
10 mg/m2 dag 1,8,15,22. Cycle length is 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard Cabazitaxel Schedule | Active comparator | Cabazitaxel 25 mg/m2 every three weeks Receives: Drug: Cabazitaxel |
| Weekly cabazitaxel schedule | Experimental | cabazitaxel 10 mg/m2 given weekly for 5 consecutive weeks of a six week cycle Receives: Drug: weekly cabazitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative cumulative dose of cabazitaxel at week 18
The primary endpoint compares the cumulative dose of cabazitaxel that is received relative to the planned dose at 18 weeks of therapy. The cumulative dose of cabazitaxel in relation to the expected dose is a reflection of both tolerability and efficacy. Patients stopping treatment due to disease progression prior to week 18 will have lower relative cumulative doses as will patients with poor tolerability due to dose reductions and delays.
Measured: week 18 after start of treatment
Secondary outcomes (3)
Overall Survival
Overall survival is defined as the length of time from randomization to death from any cause
Measured: when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date
Progression free survival
Progression free survival is defined as the length of time from randomisation to the first documentation of one of the following: PSA progression or pain progression or death due to any cause or radiological disease progression
Measured: when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date
PSA Response
Only considered after 12 weeks of treatment. PSA response is defined as a 50% or greater decline in serum PSA from baseline given that baseline PSA is at least 10 ng/ml
Measured: when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration Resistant 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jeffrey Yachnin M.D., PhD.
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor-investigator, Jeffrey Yachnin M.D., PhD., Karolinska University Hospital
- Investigators
- Jeffrey R Yachnin, MD, PhD, Study chair, Karolinska University Hosptial
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01541007
- Sponsor's protocol ID
- 2011-004178-27
- Acronym
- ConCab
- Status last verified
- Oct 2015
- First submitted
- 23 Feb 2012
- Last updated
- 2 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open Label, Multicenter, Phase II Trial Comparing The Conventional 3 Weekly Schedule Of Cabazitaxel With A Weekly Regimen In Patients With Metastatic Castration Resistant Prostate Cancer
- ClinicalTrials.gov ID
- NCT01541007
- Acronym / sponsor ID
- ConCab / 2011-004178-27
- Keywords
- Prostate Cancer, Metastatic, Castration Resistant
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jeffrey Yachnin M.D., PhD.University, hospital or other
- Collaborators
- Sanofi
- Study start
- Apr 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cabazitaxel has shown significant efficacy as second line chemotherapy after Docetaxel in men with metastatic castration resistant prostate cancer. This was demonstrated in the Tropic Study where Cabazitaxel showed survival superiority compared to mitoxantrone. Almost one in 4 patients treated with Cabazitaxel in this study required dose reductions or dose delays or stopped treatment due to toxicity. ConCab examines another scheduling for cabazitaxel to see if we can improve tolerability so that patients will receive a higher percentage of the treatment as planned.
Detailed description
ConCab compares the standard treatment of cabazitaxel 25 mg/m2 every three weeks with an experimental scheduling of 10 mg/m2 for 5 consecutive weeks of a 6 week cycle. In both study arms the planned cumulative dose of cabazitaxel at week 18 is 150 mg/m2. Our study aims to evaluate differences in the total received dose in relation to the planned dose as a measure of which of the 2 treatment schedules is superior.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Cabazitaxel Schedule | Active comparator | Drug: CabazitaxelCabazitaxel 25 mg/m2 every three weeks |
| Weekly cabazitaxel schedule | Experimental | Drug: weekly cabazitaxelcabazitaxel 10 mg/m2 given weekly for 5 consecutive weeks of a six week cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histological confirmed prostate cancer
- Macroscopic metastatic disease
- Prior treatment with Docetaxel
- Castration resistant disease defined as:Serum testosterone (< 0.5 ng/ml) and:
- Increase in measurable disease (RECIST 1.1, see appendix 10) or
Key exclusion criteria (29 listed)
- Less than 21 days since prior treatment with chemotherapy
- Less than 14 days since radiotherapy or surgery to the start of cabazitaxel - Less than 4 weeks after stopping endocrine therapies including antiandrogen, abiraterone or other new agents.
- Prior isotope therapy or radiotherapy to > 30% of bone marrow (whole pelvic radiotherapy is not an exclusion criteria)
- Persistent adverse events from previous cancer therapies > grade 1 (CTCAE - Version 4.0) with the exception of alopecia. (With respect to peripheral neuropathy and nail changes grade 2 is acceptable)
- ECOG performance status > 1
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 |
|---|---|---|
| Cabazitaxel25 mg/m2 every three weeks | Drug | Standard Cabazitaxel Schedule |
| weekly cabazitaxel10 mg/m2 dag 1,8,15,22. Cycle length is 6 weeks | Drug | Weekly cabazitaxel schedule |
Primary outcome
Relative cumulative dose of cabazitaxel at week 18
Time frame: week 18 after start of treatment
The primary endpoint compares the cumulative dose of cabazitaxel that is received relative to the planned dose at 18 weeks of therapy. The cumulative dose of cabazitaxel in relation to the expected dose is a reflection of both tolerability and efficacy. Patients stopping treatment due to disease progression prior to week 18 will have lower relative cumulative doses as will patients with poor tolerability due to dose reductions and delays.
3 secondary outcomes
Overall Survival
Time frame: when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date
Progression free survival
Time frame: when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date
PSA Response
Time frame: when the last enrolled patient has completed 18 weeks of therapy or has stopped therapy at an earlier date
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2015.
Related trials for Metastatic Castration Resistant Prostate Cancer
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RecruitingPhase 2
A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer
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ARCTIC: Liquid Biomarkers in the Prospective Androgen Receptor Signaling Inhibitors (ARSI) Resistance Clinical Trials
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Active, not recruitingPhase 2
FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)
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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.
Jeffrey R Yachnin, MD, PhD study chair
Karolinska University Hosptial
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 Cabazitaxel and weekly cabazitaxel in people with Metastatic Castration Resistant Prostate Cancer, run by Jeffrey Yachnin M.D., PhD. at 1 site in Sweden.
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 8 inclusion and 29 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 2 Nov 2015. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Relative cumulative dose of cabazitaxel at week 18 (time frame: week 18 after start of treatment). 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 2 Nov 2015.