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Phase I study of olaratumab in Japanese patients with advanced solid tumors.

Doi T, Ma Y, Dontabhaktuni A, Nippgen C, Nippgen J, Ohtsu A - Cancer Sci. (2014)

Bottom Line: The most common olaratumab-related treatment-emergent adverse events (TEAEs) were proteinuria (25.0%) and elevated aspartate transaminase (12.5%).One patient (cohort 2) had two olaratumab-related Grade 3 TEAEs (increased aspartate aminotransferase and tumor hemorrhage); otherwise, olaratumab-related TEAEs were Grade 1/2.Seven patients (43.8%) had a best response of stable disease.

View Article: PubMed Central - PubMed

Affiliation: National Cancer Center Hospital East, Kashiwa, Chiba, Japan.

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Related in: MedlinePlus

Comparison of PK parameters clearance and exposure between non-Asian and Asian patients following multiple infusions of olaratumab. Shown are CLss (circles) and AUCτ (triangles) for the 20 mg/kg-every-2-weeks groups. White circles (○) = CLss, non-Asian patients; black circles (•) = CLss, Asian patients; white triangles (▵) = AUCτ, non-Asian patients; black triangles (▴) = AUCτ Asian patients. AUCτ, area under the concentration versus time curve during one dosing interval; CLss, total body clearance of drug calculated after intravenous administration at steady state.
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fig03: Comparison of PK parameters clearance and exposure between non-Asian and Asian patients following multiple infusions of olaratumab. Shown are CLss (circles) and AUCτ (triangles) for the 20 mg/kg-every-2-weeks groups. White circles (○) = CLss, non-Asian patients; black circles (•) = CLss, Asian patients; white triangles (▵) = AUCτ, non-Asian patients; black triangles (▴) = AUCτ Asian patients. AUCτ, area under the concentration versus time curve during one dosing interval; CLss, total body clearance of drug calculated after intravenous administration at steady state.

Mentions: Comparative analyses of clearance (steady state clearance; CLss) and exposure (area under the concentration versus time curve during one dosing interval; AUCτ), following multiple infusions of olaratumab 20 mg/kg q2w, were conducted between this study of Asian patients and the US phase 1 study of non-Asian patients.(14) The results of this analysis are presented in Figure 3. As shown in the figure, the PK parameters CLss and AUCτ appear to be comparable between Asian and non-Asian patients. However, due to the small sample size, a statistical analysis was not conducted.


Phase I study of olaratumab in Japanese patients with advanced solid tumors.

Doi T, Ma Y, Dontabhaktuni A, Nippgen C, Nippgen J, Ohtsu A - Cancer Sci. (2014)

Comparison of PK parameters clearance and exposure between non-Asian and Asian patients following multiple infusions of olaratumab. Shown are CLss (circles) and AUCτ (triangles) for the 20 mg/kg-every-2-weeks groups. White circles (○) = CLss, non-Asian patients; black circles (•) = CLss, Asian patients; white triangles (▵) = AUCτ, non-Asian patients; black triangles (▴) = AUCτ Asian patients. AUCτ, area under the concentration versus time curve during one dosing interval; CLss, total body clearance of drug calculated after intravenous administration at steady state.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4317910&req=5

fig03: Comparison of PK parameters clearance and exposure between non-Asian and Asian patients following multiple infusions of olaratumab. Shown are CLss (circles) and AUCτ (triangles) for the 20 mg/kg-every-2-weeks groups. White circles (○) = CLss, non-Asian patients; black circles (•) = CLss, Asian patients; white triangles (▵) = AUCτ, non-Asian patients; black triangles (▴) = AUCτ Asian patients. AUCτ, area under the concentration versus time curve during one dosing interval; CLss, total body clearance of drug calculated after intravenous administration at steady state.
Mentions: Comparative analyses of clearance (steady state clearance; CLss) and exposure (area under the concentration versus time curve during one dosing interval; AUCτ), following multiple infusions of olaratumab 20 mg/kg q2w, were conducted between this study of Asian patients and the US phase 1 study of non-Asian patients.(14) The results of this analysis are presented in Figure 3. As shown in the figure, the PK parameters CLss and AUCτ appear to be comparable between Asian and non-Asian patients. However, due to the small sample size, a statistical analysis was not conducted.

Bottom Line: The most common olaratumab-related treatment-emergent adverse events (TEAEs) were proteinuria (25.0%) and elevated aspartate transaminase (12.5%).One patient (cohort 2) had two olaratumab-related Grade 3 TEAEs (increased aspartate aminotransferase and tumor hemorrhage); otherwise, olaratumab-related TEAEs were Grade 1/2.Seven patients (43.8%) had a best response of stable disease.

View Article: PubMed Central - PubMed

Affiliation: National Cancer Center Hospital East, Kashiwa, Chiba, Japan.

Show MeSH
Related in: MedlinePlus