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A Phase 2, Multicenter, Open-Label Study of Siltuximab (CNTO 328, Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)Unique Dataset IDProstat_Centoco_2006_98ClinicalTrial.gov IDNCT00385827
Clinical Trial Title
A Phase 2, Multicenter, Open-Label Study of Siltuximab (CNTO 328, Anti-IL-6 Monoclonal Antibody) in Combination With Mitoxantrone Versus Mitoxantrone in Subjects With Metastatic Hormone-Refractory Prostate Cancer (HRPC)
Trial Summary and Conditions
This dataset was included in the Prostate Cancer Tumor Growth data cited in The Lancet Oncology manuscript: Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer. To view the consolidated Prostate Cancer Tumor Growth data, visit: https://www.projectdatasphere.org/projectdatasphere/html/content/167
This is a 2-part, open-label (all people know the identity of the intervention) multicenter (when more than 1 hospital or medical school team work on a medical research study), Phase 2 study of the safety and efficacy of the combination of siltuximab plus mitoxantrone versus mitoxantrone in participants with metastatic HRPC who have received 1 prior Docetaxel-based chemotherapy (treatment of disease, usually cancer, by chemical agents) regimen (pattern of giving treatment). Part 1 of the study is single arm where participants will receive mitoxantrone, prednisone and siltuximab. Part 2 of the study is randomized portion (the study drug is assigned by chance), consisting of 2-arms. The experimental arm will consist of treatment with mitoxantrone, prednisone and siltuximab. The control arm will consist of treatment with mitoxantrone and prednisone. Mitoxantrone will be administered at a dose of 12 milligram per meter square (mg/m^2) intravenously (into a vein) as a 30 minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle, until disease progression or unacceptable toxicity (any harmful effect of a drug) or up to 10 cycles (a maximum total dose of approximately 120 mg/m^2). Siltuximab will be administered at a dose of 6 mg/kilogram intravenously as a 2 hour infusion, starting Day 1 of Cycle 1 to continue every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year. All participants will receive prednisone 5 mg twice daily starting with the first administration of Mitoxantrone. The duration of treatment will be a maximum of 12 months for cumulative dose. Radiologic assessments will be performed on Week 12 after the first study agent dosing, then every 9 weeks until the end of treatment and then once every 3 months until documented disease progression. Tumor (a mass in a specific area) response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
Control arm (mitoxantrone and prednisone) data files include raw data on safety, efficacy, demographics, etc.
The primary objective of Part 1 of this study was to assess the safety of CNTO 328 administered as an IV infusion in combination with mitoxantrone in subjects with metastatic hormone refractory prostate cancer (HRPC) (also known as, castration-resistant prostate cancer [CRPC]) who had received only one prior docetaxel-based chemotherapy regimen. The primary objective of Part 2 was to compare CNTO 328 in combination with mitoxantrone versus mitoxantrone with respect to the progression free survival (PFS). The secondary objectives of Part 2 were to evaluate and compare safety and other efficacy endpoints of CNTO 328 in combination with mitoxantrone versus mitoxantrone. In addition, pharmacodynamic biomarker and health outcomes responses were to be evaluated.
- Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to Month 13 or early withdrawal ] [ Designated as safety issue: Yes ] - Progression Free Survival (PFS) [ Time Frame: Day 1 up to Month 15 or until initiation of any new anti-tumor therapy or death ] [ Designated as safety issue: No ] The PFS is the time from the date of start of treatment until the first documented sign of progression (at least a 20 percent increase in the sum of the longest diameter [LD] of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new target or non-target lesions as per Response Evaluation Criteria in Solid Tumors [RECIST] or 3 or more new skeletal lesions on bone scan with confirmation of second bone scan or with clinical deterioration) or death, whichever occurs first.
To gain access to the data and analytic tools click here.
PROTOCOL: C0328T07 Protocol.pdf
CRF: C0328T07 Annotated CRFs 20080808.pdf
DATA DICTIONARY: C0328T07 Data Description.pdf
DATA (COMPARATOR ARM): datasets.zip