Clinical Trials/NCT01513733

NCT01513733

Completed

Phase 1

The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Castration-Resistant Heavily Pre-treated Prostate Cancer

Andrew J. Armstrong, MD2 sites in 1 country25 target enrollmentJanuary 2012

ConditionsProstate Cancer

Interventionstasquinimod tasquinimod 0.25 mg; 0.5 mg tasquinimod 0.25 mg; 0.5 mg; 1.0 mg

Drugstasquinimod tasquinimod 0.25 mg; 0.5 mg tasquinimod 0.25 mg; 0.5 mg; 1.0 mg

Overview

Phase: Phase 1
Intervention: tasquinimod
Conditions: Prostate Cancer
Sponsor: Andrew J. Armstrong, MD
Enrollment: 25
Locations: 2
Primary Endpoint: Number of participants who experience dose limiting toxicities at the highest titrated dose for each dose level
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

January 2012

End Date

June 2016

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

Andrew J. Armstrong, MD

Responsible Party

Sponsor Investigator

Principal Investigator

Andrew J. Armstrong, MD

Assoc Professor of Medicine

Duke University

Eligibility Criteria

Inclusion Criteria

•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;
•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;

Exclusion Criteria

•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;
•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

Arms & Interventions

Tasquinimod single dose

Intervention: tasquinimod

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: tasquinimod 0.25 mg; 0.5 mg

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: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg

Outcomes

Primary Outcomes

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).

Secondary Outcomes

Evaluation of progression free survival(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(Every 3 weeks)
Evaluation of overall response(Every 9 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(Every 3 weeks)
Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)(Every 3 weeks)
The concentration of tasquinimod and cabazitaxel in blood plasma(12 weeks)
Number and percent of participants that are alive(2 years)
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.(Every 3 weeks)
Changes in bone alkaline phosphatase and LDH over time(Every 3 weeks)