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The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer (CATCH)

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ClinicalTrials.gov Identifier: NCT01513733
Recruitment Status : Completed
First Posted : January 20, 2012
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Andrew J. Armstrong, MD, Duke University

Tracking Information
First Submitted Date  ICMJE January 17, 2012
First Posted Date  ICMJE January 20, 2012
Last Update Posted Date September 4, 2018
Study Start Date  ICMJE January 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: January 17, 2012)
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). [ Time Frame: 32 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).
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2017)
  • Evaluation of progression free survival [ Time Frame: Every 9 weeks ]
    Preliminary evidence of durable efficacy will be based on a modified PCWG2-defined radiologic progression-free survival including RECIST 1.1 criteria (PFS).
  • Evaluation of overall response [ Time Frame: Every 9 weeks ]
    Radiologic response criteria using RECIST 1.1 (overall response)
  • 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 ]
    Overall survival
  • Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle) [ Time Frame: Every 3 weeks ]
    Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)
  • The concentration of tasquinimod and cabazitaxel in blood plasma [ Time Frame: 12 weeks ]
    Pharmacokinetic analysis of tasquinimod and cabazitaxel (cycle 1-4 only)
  • 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 ]
    Descriptive statistics will be used to summarize laboratory variables
Original Secondary Outcome Measures  ICMJE
 (submitted: January 17, 2012)
  • Evaluation of progression free survival [ Time Frame: 32 weeks ]
    Preliminary evidence of durable efficacy will be based on a modified PCWG2-defined radiologic progression-free survival including RECIST 1.1 criteria (PFS).
  • Preliminary evidence of efficacy will be determined by several criteria, one of which is PSA declines [ Time Frame: 32 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.
  • Preliminary evidence of efficacy will be determined by several criteria, one of which is circulating tumor cell changes over time [ Time Frame: 32 weeks ]
    Favorable changes in circulating tumor cell number (>=5 to <5) and proportion of men who achieve a reduction in CTC count will be a secondary endpoint which will be measured.
  • Measurement of the rates of radiographic response along with duration of responses. [ Time Frame: 32 weeks ]
    Radiologic response will be determined by criteria using RECIST 1.1 (overall response).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer
Official Title  ICMJE The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Castration-Resistant Heavily Pre-treated Prostate Cancer
Brief 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. 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: tasquinimod
    tasquinimod 0.25 mg continuously
  • Drug: tasquinimod 0.25 mg; 0.5 mg
    tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
  • Drug: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg
    tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated
Study Arms  ICMJE
  • Experimental: Tasquinimod single dose
    Intervention: Drug: tasquinimod
  • Experimental: tasquinimod 0.25 mg followed by 0.5 mg
    tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
    Intervention: Drug: tasquinimod 0.25 mg; 0.5 mg
  • Experimental: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg
    tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated
    Intervention: Drug: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 26, 2016)
25
Original Estimated Enrollment  ICMJE
 (submitted: January 17, 2012)
32
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell features;
  2. At least 18 years of age when signing the Informed Consent;
  3. Presence of metastatic disease on bone scan or CT/MRI imaging;
  4. Ongoing androgen deprivation therapy with a gonadotropin releasing hormone (GnRH) analogue or orchiectomy (i.e., medical or surgical castration);
  5. 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;
  6. Serum testosterone level < 50 ng/dL at the Screening Visit;
  7. 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;
  8. No more than three prior chemotherapy regimens with at least one regimen containing docetaxel (unless intolerant as per # 7 above);
  9. Karnofsky Performance Status of >70;
  10. Estimated life expectancy of at least three months;
  11. Able to swallow the study drug and comply with study requirements;
  12. Willing and able to give informed consent.

Exclusion Criteria:

  1. Subjects > 80 years old (dose escalation phase only, due to lower clearance in elderly patients);
  2. Severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment;
  3. 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);
  4. 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)
  5. Total bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 times the upper limit of normal at the Screening Visit;
  6. Creatinine > 1.5 x ULN at the Screening visit;
  7. History of another malignancy within the previous 3 years other than non-melanomatous skin cancer or non-invasive bladder cancer treated with curative intent;
  8. 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;
  9. 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;
  10. Ongoing treatment with warfarin unless the international normalized ratio (INR) is well controlled and below 4
  11. 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.
  12. Ongoing treatment with sensitive CYP1A2 substrates or CYP1A2 substrates with narrow therapeutic range (Appendix 3).
  13. Ongoing treatment with CYP3A4 substrates with narrow therapeutic range (Appendix 3).
  14. Radiation therapy within 2 weeks (if single fraction of radiotherapy within 2 weeks) and radionuclide therapy within 8 weeks of Day 1 visit;
  15. Planned palliative procedures for alleviation of bone pain such as radiation therapy or surgery;
  16. Structurally unstable bone lesions suggesting impending fracture;
  17. 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
  18. Use of an investigational agent within four weeks of Day 1 visit or plans to initiate treatment with an investigational agent during the study;
  19. Gastrointestinal disorder affecting absorption (e.g., gastrectomy, active peptic ulcer disease within last three months);
  20. Major surgery within four weeks prior to Day 1 visit.
  21. Presence of NCI CTC grade >1 peripheral neuropathy
  22. History of pancreatitis
  23. 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).
  24. 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).
  25. Documented prior disease progression on tasquinimod -
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01513733
Other Study ID Numbers  ICMJE Pro00032421
c11-082 ( Other Grant/Funding Number: PCCTC )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andrew J. Armstrong, MD, Duke University
Study Sponsor  ICMJE Andrew J. Armstrong, MD
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Armstrong, MD Duke Cancer Institute
PRS Account Duke University
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP