niacinamide has been researched along with Hypocalcemia in 2 studies
nicotinamide : A pyridinecarboxamide that is pyridine in which the hydrogen at position 3 is replaced by a carboxamide group.
Hypocalcemia: Reduction of the blood calcium below normal. Manifestations include hyperactive deep tendon reflexes, Chvostek's sign, muscle and abdominal cramps, and carpopedal spasm. (Dorland, 27th ed)
Excerpt | Relevance | Reference |
---|---|---|
"Effective adverse event (AE) management is critical to maintaining patients on anticancer therapies." | 2.80 | Safety and tolerability of sorafenib in patients with radioiodine-refractory thyroid cancer. ( Ando, Y; Bonichon, F; Brose, MS; Chung, J; Fassnacht, M; Fugazzola, L; Gao, M; Hadjieva, T; Hasegawa, Y; Kappeler, C; Meinhardt, G; Park, DJ; Schlumberger, M; Shi, Y; Shong, YK; Smit, JW; Worden, F, 2015) |
Timeframe | Studies, this research(%) | All Research% |
---|---|---|
pre-1990 | 0 (0.00) | 18.7374 |
1990's | 0 (0.00) | 18.2507 |
2000's | 0 (0.00) | 29.6817 |
2010's | 2 (100.00) | 24.3611 |
2020's | 0 (0.00) | 2.80 |
Authors | Studies |
---|---|
McKay, RR | 1 |
Lin, X | 1 |
Perkins, JJ | 1 |
Heng, DY | 1 |
Simantov, R | 1 |
Choueiri, TK | 1 |
Worden, F | 1 |
Fassnacht, M | 1 |
Shi, Y | 1 |
Hadjieva, T | 1 |
Bonichon, F | 1 |
Gao, M | 1 |
Fugazzola, L | 1 |
Ando, Y | 1 |
Hasegawa, Y | 1 |
Park, DJ | 1 |
Shong, YK | 1 |
Smit, JW | 1 |
Chung, J | 1 |
Kappeler, C | 1 |
Meinhardt, G | 1 |
Schlumberger, M | 1 |
Brose, MS | 1 |
Trial | Phase | Enrollment | Study Type | Start Date | Status | ||
---|---|---|---|---|---|---|---|
A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer[NCT00984282] | Phase 3 | 417 participants (Actual) | Interventional | 2009-10-15 | Completed | ||
[information is prepared from clinicaltrials.gov, extracted Sep-2024] |
Sorafenib AUC(0-12h),ss (area under the concentration time curve from time 0 to 12 hours at steady state) was estimated from the steady state plasma concentration. (NCT00984282)
Timeframe: A single pharmacokinetic plasma sample was collected at steady state (after 14 days of uninterrupted, unmodified sorafenib dosing)
Intervention | mg*h/L (Geometric Mean) |
---|---|
Sorafenib (Nexavar, BAY43-9006) | 75.4 |
Disease control rate was defined as the proportion of subjects whose best response was complete response (CR), partial response (PR), or stable disease (SD). Per Response Evaluation Criteria in Solid Tumors (RECIST) criteria, CR and PR were to be confirmed by another scan at least 4 weeks later; SD had to be documented at least 4 weeks after date of randomization. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. SD = steady state of disease which is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Intervention | Percentage of participants (Number) |
---|---|
Sorafenib (Nexavar, BAY43-9006) | 86.2 |
Placebo | 74.6 |
Duration of response was defined as the time from the first documented objective response of PR or CR, whichever was noted earlier, to disease progression or death (if death occurred before progression was documented). CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Intervention | Days (Median) |
---|---|
Sorafenib (Nexavar, BAY43-9006) | 309 |
Placebo | NA |
Overall survival was defined as the time (days) from date of randomization to date of death due to any cause. Subjects still alive at the time of analysis were censored at their date of last contact. Since the median value could not be estimated due to censored data, the percentage of participants who died is presented. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (30 AUG 2017), study duration approximately eight years
Intervention | Percentage of participants (Number) |
---|---|
Sorafenib (Nexavar, BAY43-9006) | 52.7 |
Placebo | 54.8 |
PFS=time from randomization to first observed disease progression (radiological according to central assessment or clinical due to bone irradiation, whichever is earlier), or death due to any cause, if death occurred before progression. Progression was assessed by RECIST criteria, version 1.0, modified for bone lesions. PFS for participants without disease progression or death at the time of analysis or unblinding were censored at the last date of tumor assessment before unblinding. Participants with no tumor evaluation after baseline were censored at Day 1. PD (Progression Disease)=At least a 20% increase in sum of longest diameters (LD) of measured lesions taking as reference the smallest sum LD on study since the treatment started or the appearance of 1 or more new lesions. New lesions also constituted PD. In exceptional circumstances, unequivocal progression of a nonmeasured lesion may have been accepted as evidence of disease progression in participants with measurable disease. (NCT00984282)
Timeframe: Final analysis to be performed when approximately 267 progression-free survival events (centrally assessed) had occurred, study duration approximately three years
Intervention | Days (Median) |
---|---|
Sorafenib (Nexavar, BAY43-9006) | 329 |
Placebo | 175 |
Response rate was defined as the proportion of subjects whose best response was CR or PR. Per RECIST, CR and PR was to be confirmed by another scan at least 4 weeks later. CR = Disappearance of all clinical and radiological evidence of tumor (both target and no-target). PR = At least a 30% decrease in the sum of LD of target lesions taking as reference the baseline sum. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Intervention | Percentage of participants (Number) |
---|---|
Sorafenib (Nexavar, BAY43-9006) | 12.24 |
Placebo | 0.5 |
Time to progression was defined at the time (days) from randomization to progression (based on central assessment [radiological and clinical progression due to bone irradiation]) (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Intervention | Days (Median) |
---|---|
Sorafenib (Nexavar, BAY43-9006) | 337 |
Placebo | 175 |
The magnitude of change from baseline in target lesion size in evaluable participants with scans was determined. (NCT00984282)
Timeframe: From randomization of the first subject until the database cut-off (31 Aug 2012), study duration approximately three years
Intervention | Percentage of participants (Number) | |||||
---|---|---|---|---|---|---|
Reduction ≥ 30% | Reduction ≥ 20% but < 30% | Reduction ≥ 10% but < 20% | Reduction > 0% but < 10% | Growth ≥ 0% | Not assessed | |
Placebo | 1.0 | 1.5 | 3.5 | 21.9 | 62.7 | 9.5 |
Sorafenib (Nexavar, BAY43-9006) | 17.3 | 15.3 | 22.4 | 22.4 | 12.8 | 9.7 |
1 trial available for niacinamide and Hypocalcemia
Article | Year |
---|---|
Safety and tolerability of sorafenib in patients with radioiodine-refractory thyroid cancer.
Topics: Adenocarcinoma, Follicular; Adenoma, Oxyphilic; Aged; Antineoplastic Agents; Carcinoma, Papillary; D | 2015 |
1 other study available for niacinamide and Hypocalcemia
Article | Year |
---|---|
Prognostic significance of bone metastases and bisphosphonate therapy in patients with renal cell carcinoma.
Topics: Aged; Antineoplastic Agents; Axitinib; Bisphosphonate-Associated Osteonecrosis of the Jaw; Bone Dens | 2014 |