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- Klinische proef NCT01513733
The CATCH Prostate Cancer Trial: Cabazitaxel And Tasquinimod in Men With Prostate Cancer (CATCH)
31 augustus 2018 bijgewerkt door: Andrew J. Armstrong, MD
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).
Studie Overzicht
Toestand
Voltooid
Conditie
Studietype
Ingrijpend
Inschrijving (Werkelijk)
25
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60637
- The University of Chicago
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North Carolina
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Durham, North Carolina, Verenigde Staten, 27710
- Duke Cancer Institute
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 79 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Mannelijk
Beschrijving
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;
- Able to swallow the study drug and comply with study requirements;
- Willing and able to give informed consent.
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
- 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 -
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Tasquinimod single dose
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tasquinimod 0.25 mg continuously
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Experimenteel: tasquinimod 0.25 mg followed by 0.5 mg
tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
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tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
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Experimenteel: 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
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tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of participants who experience dose limiting toxicities at the highest titrated dose for each dose level
Tijdsspanne: 6 weeks
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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).
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6 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Evaluation of progression free survival
Tijdsspanne: Every 9 weeks
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Preliminary evidence of durable efficacy will be based on a modified PCWG2-defined radiologic progression-free survival including RECIST 1.1 criteria (PFS).
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Every 9 weeks
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Evaluation of overall response
Tijdsspanne: Every 9 weeks
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Radiologic response criteria using RECIST 1.1 (overall response)
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Every 9 weeks
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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
Tijdsspanne: Every 3 weeks
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Every 3 weeks
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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
Tijdsspanne: Every 3 weeks
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Every 3 weeks
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Number and percent of participants that are alive
Tijdsspanne: 2 years
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Overall survival
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2 years
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Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)
Tijdsspanne: Every 3 weeks
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Detailed characterization of all NCI CTC v4.0 toxicities over time (per cycle)
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Every 3 weeks
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The concentration of tasquinimod and cabazitaxel in blood plasma
Tijdsspanne: 12 weeks
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Pharmacokinetic analysis of tasquinimod and cabazitaxel (cycle 1-4 only)
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12 weeks
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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.
Tijdsspanne: Every 3 weeks
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Every 3 weeks
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Changes in bone alkaline phosphatase and LDH over time
Tijdsspanne: Every 3 weeks
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Descriptive statistics will be used to summarize laboratory variables
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Every 3 weeks
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Andrew Armstrong, MD, Duke Cancer Institute
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Nuttige links
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2012
Primaire voltooiing (Werkelijk)
1 juni 2015
Studie voltooiing (Werkelijk)
1 juni 2016
Studieregistratiedata
Eerst ingediend
17 januari 2012
Eerst ingediend dat voldeed aan de QC-criteria
17 januari 2012
Eerst geplaatst (Schatting)
20 januari 2012
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 september 2018
Laatste update ingediend die voldeed aan QC-criteria
31 augustus 2018
Laatst geverifieerd
1 augustus 2018
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Pro00032421
- c11-082 (Ander subsidie-/financieringsnummer: PCCTC)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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