Prostate CancerPhase 1CATCHNCT01513733
The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer
A Phase 1 study testing tasquinimod, tasquinimod 0.25 mg; 0.5 mg and tasquinimod 0.25 mg; 0.5 mg; 1.0 mg in people with Prostate Cancer, run by Andrew J. Armstrong, MD at 2 sites in United States.
Trial summary
The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies, cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes the backbone upon which to improve upon. Read more about this study
- Who is it for?
- Ages 18 to 79 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- tasquinimod, tasquinimod 0.25 mg; 0.5 mg and tasquinimod 0.25 mg; 0.5 mg; 1.0 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2012to Jun 2016
- Phase
- Phase 1
- 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 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features;
- At least 18 years of age when signing the Informed Consent;
- Presence of metastatic disease on bone scan or CT/MRI imaging;
- Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration);
- For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial;
- Serum testosterone level < 50 ng/dL at the Screening Visit;
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- Progressive disease on or following docetaxel-based chemotherapy with medical or surgical castration. Patients who are intolerant of docetaxel are also allowed. Disease progression for study entry is defined as one or more of the following three criteria: 1) PSA progression defined by a minimum of three rising PSA levels with an interval of ≥ 1 week between each determination. The PSA value at the Screening visit should be ≥ 2 μg/L (2 ng/mL); 2) Soft tissue disease progression defined by RECIST 1.1; 3) Bone metastatic disease progression defined by one or more new lesions on bone scan that are not clinically consistent with tumor flare;
- No more than three prior chemotherapy regimens with at least one regimen containing docetaxel (unless intolerant as per # 7 above);
- Karnofsky Performance Status of >70;
- Estimated life expectancy of at least three months;
- Able to swallow the study drug and comply with study requirements;
- Willing and able to give informed consent.
Who cannot join
- Subjects > 80 years old (dose escalation phase only, due to lower clearance in elderly patients);
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;
- Metastases in the brain or active epidural disease (NOTE: patients with treated epidural disease are allowed provided follow up imaging documents stability of epidural disease);
- Absolute neutrophil count < 1,200/μL, platelet count < 100,000/μL, and hemoglobin <9 g/dL at the Screening Visit; (NOTE: patients may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the Screening Visit)
- Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal at the Screening Visit;
- Creatinine > 1.5 x ULN at the Screening visit;
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- History of another malignancy within the previous 3 years other than non-melanomatous skin cancer or non-invasive bladder cancer treated with curative intent;
- Treatment with androgen receptor antagonists (bicalutamide, flutamide, nilutamide, MDV3100), 5-α reductase inhibitors (finasteride, dutasteride), estrogens (ie DES), sipuleucel-T, or chemotherapy within 28 days of Day 1 visit or plans to initiate treatment with any of these treatments during the study;
- Use of herbal products that may decrease PSA levels or systemic corticosteroids greater than the equivalent of 10 mg of prednisone/prednisolone per day within four weeks of Day 1 visit;
- Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4
- Exposure to ketoconazole or other strong CYP3A4 inhibitors or inducers intravenously or orally within 28 days prior to Day 1 Visit. For abiraterone acetate or TAK700, 14 days washout is needed.
- Ongoing treatment with sensitive CYP1A2 substrates or CYP1A2 substrates with narrow therapeutic range (Appendix 3).
- Ongoing treatment with CYP3A4 substrates with narrow therapeutic range (Appendix 3).
- Radiation therapy within 2 weeks (if single fraction of radiotherapy within 2 weeks) and radionuclide therapy within 8 weeks of Day 1 visit;
- Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery;
- Structurally unstable bone lesions suggesting impending fracture;
- Clinically significant cardiovascular disease including:myocardial infarction within 6 months, uncontrolled angina within 3 months, congestive heart failure, Diagnosed or suspected congenital long QT syndrome; significant ventricular arrhythmias, Prolonged corrected QT interval by the Fridericia or Bazett correction formula, History of Mobitz II second degree or third degree heart block without a permanent pacemaker in place; Hypotension (systolic blood pressure < 86 mMHg or bradycardia with a heart rate < 50 beats per minute on any ECG taken at the Screening or Day 1 visit; Uncontrolled hypertension; TIA or stroke/CVA within 6 months of Day 1 visit; Rest limb claudication or ischemia within 6 months of Day 1 visit
- Use of an investigational agent within four weeks of Day 1 visit or plans to initiate treatment with an investigational agent during the study;
- Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months);
- Major surgery within four weeks prior to Day 1 visit.
- Presence of NCI CTC grade >1 peripheral neuropathy
- History of pancreatitis
- Known positive serology for HIV (patients with known history of HIV will be excluded because of potential for unforeseen toxicity and morbidity in an immunocompromised host).
- Chronic hepatitis B or C with advanced, decompensated hepatic disease, or cirrhosis of the liver or history of a chronic viral hepatitis or known viral hepatitis carrier (patients recovered from hepatitis will be allowed to enter the study).
- Documented prior disease progression on tasquinimod -
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Chicago
Chicago, Illinois, 60637
Duke Cancer Institute
Durham, North Carolina, 27710
About this study
Official title: The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Castration-Resistant Heavily Pre-treated Prostate Cancer
The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies, cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes the backbone upon which to improve upon. Thus, the primary objective of this study is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).
- Conditions
- Prostate Cancer
- Being tested
- tasquinimod, tasquinimod 0.25 mg; 0.5 mg, tasquinimod 0.25 mg; 0.5 mg; 1.0 mg
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tasquinimodDrug
tasquinimod 0.25 mg continuously
tasquinimod 0.25 mg; 0.5 mgDrug
tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
tasquinimod 0.25 mg; 0.5 mg; 1.0 mgDrug
tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated
| Study group | Role | What they receive |
|---|---|---|
| Tasquinimod single dose | Experimental | Not described Receives: Drug: tasquinimod |
| tasquinimod 0.25 mg followed by 0.5 mg | Experimental | tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated Receives: Drug: tasquinimod 0.25 mg; 0.5 mg |
| tasquinimod 0.25 mg; 0.5 mg; 1.0 mg | Experimental | tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated Receives: Drug: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience dose limiting toxicities at the highest titrated dose for each dose level
The primary objective is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).
Measured: 6 weeks
Secondary outcomes (9)
Evaluation of progression free survival
Preliminary evidence of durable efficacy will be based on a modified PCWG2-defined radiologic progression-free survival including RECIST 1.1 criteria (PFS).
Measured: Every 9 weeks
Evaluation of overall response
Radiologic response criteria using RECIST 1.1 (overall response)
Measured: Every 9 weeks
Preliminary evidence of response efficacy as measured by the rates of PSA decline (waterfall plot) and benchmarks of reaching a >30% decline within 3 months, a PSA decline >50% and >90%, and PSA normalization. Duration of PSA responses will be measured
Measured: Every 3 weeks
Favorable changes in circulating tumor cell number (5 or greater to less than 5) and proportion of men who achieve a reduction in CTC count
Measured: Every 3 weeks
Number and percent of participants that are alive
Overall survival
Measured: 2 years
Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)
Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)
Measured: Every 3 weeks
The concentration of tasquinimod and cabazitaxel in blood plasma
Pharmacokinetic analysis of tasquinimod and cabazitaxel (cycle 1-4 only)
Measured: 12 weeks
Pain response, as measured by percentage of patients with a reduction of at least 2 points on the visual analog scale despite a stable pain regimen. Pain scores over time will be described in an exploratory fashion.
Measured: Every 3 weeks
Changes in bone alkaline phosphatase and LDH over time
Descriptive statistics will be used to summarize laboratory variables
Measured: Every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew J. Armstrong, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Andrew J. Armstrong, MD, Duke University
- Investigators
- Andrew Armstrong, MD, Principal investigator, Duke Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513733
- Sponsor's protocol ID
- Pro00032421
- Other IDs
- c11-082
- Acronym
- CATCH
- Status last verified
- Aug 2018
- First submitted
- 17 Jan 2012
- Last updated
- 4 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Castration-Resistant Heavily Pre-treated Prostate Cancer
- ClinicalTrials.gov ID
- NCT01513733
- Acronym / sponsor ID
- CATCH / Pro00032421
- Conditions
- Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Andrew J. Armstrong, MDUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 20 Jan 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.
The standard of care for men with metastatic CRPC in 2010 following progression on docetaxel is cabazitaxel or abiraterone acetate/prednisone. Based on results from two other studies, cabazitaxel and prednisone has become a standard second line chemotherapy regimen and becomes the backbone upon which to improve upon. Thus, the primary objective of this study is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tasquinimod single dose | Experimental | Drug: tasquinimod |
| tasquinimod 0.25 mg followed by 0.5 mg | Experimental | Drug: tasquinimod 0.25 mg; 0.5 mgtasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated |
| tasquinimod 0.25 mg; 0.5 mg; 1.0 mg | Experimental | Drug: tasquinimod 0.25 mg; 0.5 mg; 1.0 mgtasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features;
- At least 18 years of age when signing the Informed Consent;
- Presence of metastatic disease on bone scan or CT/MRI imaging;
- Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration);
- For patients who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the trial;
Key exclusion criteria (25 listed)
- Subjects > 80 years old (dose escalation phase only, due to lower clearance in elderly patients);
- Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;
- Metastases in the brain or active epidural disease (NOTE: patients with treated epidural disease are allowed provided follow up imaging documents stability of epidural disease);
- Absolute neutrophil count < 1,200/μL, platelet count < 100,000/μL, and hemoglobin <9 g/dL at the Screening Visit; (NOTE: patients may not have received any growth factors or blood transfusions within seven days of the hematologic laboratory values obtained at the Screening Visit)
- Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal at the Screening Visit;
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 |
|---|---|---|
| tasquinimodtasquinimod 0.25 mg continuously | Drug | Tasquinimod single dose |
| tasquinimod 0.25 mg; 0.5 mgtasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated | Drug | tasquinimod 0.25 mg followed by 0.5 mg |
| tasquinimod 0.25 mg; 0.5 mg; 1.0 mgtasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated | Drug | tasquinimod 0.25 mg; 0.5 mg; 1.0 mg |
Primary outcome
Number of participants who experience dose limiting toxicities at the highest titrated dose for each dose level
Time frame: 6 weeks
The primary objective is to determine the recommended dose of tasquinimod in combination with cabazitaxel and prednisone based on safety and tolerability in men with chemorefractory metastatic castration-resistant prostate cancer (CRPC).
9 secondary outcomes
Evaluation of progression free survival
Time frame: Every 9 weeks
Evaluation of overall response
Time frame: Every 9 weeks
Preliminary evidence of response efficacy as measured by the rates of PSA decline (waterfall plot) and benchmarks of reaching a >30% decline within 3 months, a PSA decline >50% and >90%, and PSA normalization. Duration of PSA responses will be measured
Time frame: Every 3 weeks
Favorable changes in circulating tumor cell number (5 or greater to less than 5) and proportion of men who achieve a reduction in CTC count
Time frame: Every 3 weeks
Number and percent of participants that are alive
Time frame: 2 years
Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)
Time frame: Every 3 weeks
The concentration of tasquinimod and cabazitaxel in blood plasma
Time frame: 12 weeks
Pain response, as measured by percentage of patients with a reduction of at least 2 points on the visual analog scale despite a stable pain regimen. Pain scores over time will be described in an exploratory fashion.
Time frame: Every 3 weeks
Changes in bone alkaline phosphatase and LDH over time
Time frame: Every 3 weeks
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 4 Sep 2018.
- Duke Cancer InstituteLink provided by the sponsor.
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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.
Andrew Armstrong, MD principal investigator
Duke Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing tasquinimod, tasquinimod 0.25 mg; 0.5 mg and tasquinimod 0.25 mg; 0.5 mg; 1.0 mg in people with Prostate Cancer, run by Andrew J. Armstrong, MD at 2 sites 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 12 inclusion and 25 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 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants who experience dose limiting toxicities at the highest titrated dose for each dose level (time frame: 6 weeks). 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 4 Sep 2018.