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

NCT01513733 | Completed Phase 1 DMC

• 2 other identifiers: Pro00032421c11-082
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• 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).

  6 weeks

Secondary Outcomes (9)

• Evaluation of progression free survival

  Every 9 weeks

• Evaluation of overall response

  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

• 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

• Number and percent of participants that are alive

  2 years

Study Arms (3)

Tasquinimod single dose

EXPERIMENTAL

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

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

Drug: tasquinimod 0.25 mg; 0.5 mg; 1.0 mg

Interventions

tasquinimod DRUG

tasquinimod 0.25 mg continuously

Tasquinimod single dose

tasquinimod 0.25 mg; 0.5 mg DRUG

tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated

tasquinimod 0.25 mg followed by 0.5 mg

tasquinimod 0.25 mg; 0.5 mg; 1.0 mg DRUG

tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated

tasquinimod 0.25 mg; 0.5 mg; 1.0 mg

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Able to swallow the study drug and comply with study requirements;
• Willing and able to give informed consent.

You may not qualify if:

• 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
• 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;

Sponsors & Collaborators

• Andrew J. Armstrong, MD: lead

Study Sites (2)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

Duke Cancer Institute

Durham, North Carolina, 27710, United States

Location

Related Links

• Duke Cancer Institute

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

tasquinimod

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Andrew Armstrong, MD

  Duke Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc Professor of Medicine

Study Record Dates

• First Submitted: January 17, 2012
• First Posted: January 20, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2016
• Last Updated: September 4, 2018

Record last verified: 2018-08

Locations

US (2)