EUCTR2007-003228-39-ITActive, not recruitingNot Applicable
A Phase III, Randomised, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of 10 mg ZD4054 in Combination with Docetaxel in Comparison with Docetaxel in Patients with Metastatic Hormone-resistant Prostate Cancer - D4320C00033
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ASTRAZENECA
- Enrollment
- 1,044
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Male
Inclusion Criteria
- •1. Provision of informed consent 2. Male, aged 18 years or older 3. Histological or cytological confirmation of adenocarcinoma of the prostate 4. Documented evidence of bone metastasis on bone scan. Patients must have disease involvement <75% of the spine, pelvis and ribs in the anteroposterior (AP) or posteroanterior (PA) view. Patients with ≤3 lesions seen on bone scan will require a CT scan, MRI or x-ray to confirm 5. Biochemical progression of prostate cancer, documented while the patient is castrate: − Biochemical progression is defined as at least 2 stepwise increases in PSA over a period of ≥1 month (values do not need to be consecutive but 2 values that have increased since the previous highest value are required) with at least 14 days between each measurement irrespective of assay or laboratory − Historical values may be used − The last PSA must be an increase of ≥50 % of the first PSA value of the 3 values or an absolute increase of ≥10 ng/mL over the initial PSA − The final PSA value must be ≥1.2 ng/mL in patients who have had a radical prostatectomy and ≥ 5ng/mL in all other patients 6. Surgically castrated or continuously medically castrated with serum testosterone ≤2.4 nmol/L (70 ng/dL). 7. World Health Organisation (WHO) performance status 0 ? 1 (see Appendix E). 8. Life expectancy of 3 months or more. For inclusion in the genetic component of the study, patients must fulfil the following criterion: 1. Provision of informed consent for genetic research. If a patient declines to participate in the genetic research, there will be no penalty or loss of benefit to the patient. The patient will not be excluded from other aspects of the study described in this Clinical Study Protocol, so long as they consent to participate.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Radiotherapy to bone lesion or prostatic bed within 4 weeks of starting study treatment 2. Prior cytotoxic chemotherapy (such as paclitaxel, docetaxel and mitoxantrone) for the treatment of recurrent prostate cancer (prior estramustine therapy is allowed), as well as other targeted cancer therapies (such as EGF, EGFR, VEGF and VEGFR) 3. Systemic radionuclide therapy (ie, strontium chloride Sr89, 186Relabeled HEDP, or 153Sm-EDTMP pentasodium) within 12 weeks of starting study treatment 4. Use of potent CYP450 inducers (such as phenytoin, rifampicin, carbamazepine, phenobarbitone, St John?s Wort) within 2 weeks of starting study treatment. Dexamethasone is a known inducer of CYP2D6 and CYP3A4 but is acceptable for this study when used as part of the standard docetaxel regime 5. Use of systemic retinoids within 2 weeks of starting study treatment 6. Have received investigational drug in another clinical study of anti-cancer therapy, within 4 weeks of starting study treatment 7. Prior therapy with endothelin receptor antagonists or family history of hypersensitivity to endothelin antagonists 8. Acute or evolving spinal cord compression or neurological symptoms or signs consistent with this. If a patient has neurologic symptoms, an MRI must be performed that demonstrates no impending or actual spinal cord compression. Stable, previously treated patients are allowed 9. Symptomatic peripheral neuropathy of CTCAE grade 2 or higher 10. Known or suspected central nervous system metastases. 11. History of past or current epilepsy, epilepsy syndrome, or other seizure disorder 12. Stage II, III or IV cardiac failure (classified according to New York Heart Association (NYHA) classification) or myocardial infarction within 6 months prior to study entry 13. QT interval corrected for heart rate eg, by Bazett?s correction >470 msec 14. Previous history or presence of another malignancy within the preceding 5 years except treated squamous/basal cell carcinoma of the skin15. In the opinion of the investigator, any evidence of severe or uncontrolled systemic disease, (eg, currently unstable or uncompensated respiratory, cardiac, hepatic or renal disease) or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the study 16. Absolute Neutrophil Count (ANC) <1.5 x 109/L (1,500/mm3); haemoglobin (Hb) <9 g/dL; platelet count <100 x 109/L (100,000/mm3). Concomitant use of erythropoietin or blood transfusions is allowed 17. Serum bilirubin >1.5 times the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert?s syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of evidence of haemolysis or hepatic pathology), who will be allowed in consultation with their physician 18. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 times the ULN or 5 times the ULN in the presence of liver metastases 19. Creatinine clearance of <50 mL/minute, determined using the Cockcroft-Gault equation or by 24-hour creatinine clearance 20. Patients who discontinue after randomisation cannot be re-enrolled. Patients who fail to meet the inclusion/exclusion criteria may be reconsidered once for participation in the study. Patients who are re-enrolled must be re-consented and will be assigned a new enrolment number [....]
Investigators
Similar Trials
Recruiting
Phase 1
A study to determine if ALXN2220 is effective, safe, and tolerable in adults with Transthyretin Amyloid Cardiomyopathy (ATTR-CM)Adults with Transthyretin Amyloid Cardiomyopathy (ATTR-CM).CTIS2023-506669-70-00Alexion Pharmaceuticals Inc.982
Active, not recruiting
Phase 1
Pembrolizumab as adjuvant therapy for resectable high-risk LA cSCCResectable high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC)MedDRA version: 20.0 Level: PT Classification code 10041823 Term: Squamous cell carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2018-001974-76-FRMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.570
Active, not recruiting
Phase 1
Phase 3 Study of Upifitamab Rilsodotin Maintenance in Platinum-Sensitive Recurrent Ovarian Cancer (UP-NEXT)Recurrent, Platinum-Sensitive Ovarian CancerMedDRA version: 21.1Level: PTClassification code 10066697Term: Ovarian cancer recurrentSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-005099-21-NOMersana Therapeutics, Inc.581
Active, not recruiting
Phase 1
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to study the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents = 6 to <18 years of ageAcute Migraine (with or without aura)MedDRA version: 20.0Level: PTClassification code 10052787Term: Migraine without auraSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: PTClassification code 10027607Term: Migraine with auraSystem Organ Class: 10029205 - Nervous system disordersMedDRA version: 20.0Level: HLTClassification code 10027603Term: Migraine headachesSystem Organ Class: 10029205 - Nervous system disordersEUCTR2021-005246-15-PLPfizer Inc.640
Active, not recruiting
Phase 1
Combining chemotherapy with either the medication entospletinib or a placebo for adults with acute myeloid leukemia that has a nucleophosmin-1 abnormalityMedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864Acute Myeloid LeukemiaEUCTR2021-000761-33-PLKronos Bio, Inc.180