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A Phase I, Open-Label study designed to assess the pharmacokinetics (PK), safety and tolerability of ipatasertib in Chinese participants. Approximately 20 Chinese participants (12 PK-evaluable participants) with locally advanced or metastatic solid tumors for whom standard therapy either does not exist or has proven ineffective will be enrolled to provide sufficient data. Participants will receive a 400-mg ipatasertib dose (two 200-mg tablets) daily orally (PO). Participants deriving clinical benefit may be offered continued treatment with ipatasertib until disease progression, at the discretion of the investigator (as assessed by the investigator) or until the study is terminated by the Sponsor.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipatasertib as a Single Agent | Experimental | Participants will receive a 400-mg Ipatasertib dose (two 200-mg tablets) orally (PO) daily (QD). This study has three study periods: a screening period (up to 14 days in length), followed by a treatment period of up to approximately 2 years (Cycle 1 will be 35 days in length, all subsequent cycles will be 28 days in length) and a 28-day follow-up period after the treatment discontinuation or study completion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipatasertib | Drug | Participants will receive a 400-mg Ipatasertib dose (two 200-mg tablets) orally (PO) daily (QD) as described above. |
|
| Measure | Description | Time Frame |
|---|---|---|
| AUC (0-inf) after a single dose and AUC (0-24) after single and multiple doses of Ipatasertib | Up to 25 months | |
| Maximum plasma concentration (Cmax) of Ipatasertib | Up to 25 months | |
| Minimum plasma concentration (Cmin) of Ipatasertib after multiple doses of Ipatasertib | Up to 25 months | |
| Time to maximum plasma concentration (tmax) of Ipatasertib | Up to 25 months | |
| Terminal half-life (t1/2) of Ipatasertib and GO37220 | Up to 25 months | |
| Apparent clearance (CL/F) of Ipatasertib and GO37220 after single and multiple doses of Ipatasertib | Up to 25 months | |
| Accumulation ratio at steady state (Rcmax) of Ipatasertib | Accumulation ratio will be calculated as follows: Rcmax = AUC24h,ss/AUC0-24 of Day 1. | Up to 25 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | Assessed by the NCI CTCAE v5.0 criteria. | Up to 25 months |
| Percentage of Participants with Adverse Events leading to Study Treatment Discontinuation, Modification or Interruption |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39721851 | Derived | Zhang J, Liu R, Sutaria D, Sane R, Fan M, Wang R, Song G, Chen K, Arzumanova K, Hu X. A Phase I Study of the Pharmacokinetics and Safety of Ipatasertib, an Akt Inhibitor in Chinese Patients With Locally Advanced or Metastatic Solid Tumors. Clin Ther. 2025 Feb;47(2):128-134. doi: 10.1016/j.clinthera.2024.11.021. Epub 2024 Dec 24. |
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Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
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| ID | Term |
|---|---|
| C583616 | ipatasertib |
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| Up to 25 months |
| Number of Deaths | Up to 25 months |