A Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Participants With Locally Advanced Or Metastatic Solid Tumors.

NCT04341259 | Completed Phase 1

• 1 other identifier: YP40057
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (7)

• 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

Secondary Outcomes (3)

• Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Up to 25 months

• Percentage of Participants with Adverse Events leading to Study Treatment Discontinuation, Modification or Interruption

  Up to 25 months

• Number of Deaths

  Up to 25 months

Study Arms (1)

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.

Drug: Ipatasertib

Interventions

Ipatasertib DRUG

Participants will receive a 400-mg Ipatasertib dose (two 200-mg tablets) orally (PO) daily (QD) as described above.

Ipatasertib as a Single Agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically documented locally advanced or metastatic solid tumor that has progressed or failed to respond to at least one prior regimen.
• Not a candidate for regimens known to provide clinical benefit.
• Evaluable or measurable disease according to RECIST, v1.1.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at screening.
• Life expectancy of \>= 12 weeks.
• Adequate haematologic and organ function within 14 days prior to initiation of study treatment.
• Women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating eggs.
• Men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm.
• Participants must reside in the People's Republic of China

You may not qualify if:

• Leptomeningeal disease as the only manifestation of the current tumor.
• Type 1 or 2 diabetes mellitus requiring insulin at study entry.
• Inability or unwillingness to swallow pills.
• Malabsorption syndrome or other condition that would interfere with enteral absorption.
• Known and untreated, or active CNS metastases (progressing or requiring anticonvulsants for symptomatic control).
• Congenital long QT syndrome or corrected QT interval (QTc) \> 480 ms.
• Active congestive heart failure or ventricular arrhythmia requiring medication.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring weekly paracentesis for 3 consecutive weeks prior to initiation of ipatasertib treatment.
• Severe infections within 4 weeks prior to screening including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
• Requirement for any daily supplemental oxygen.
• History of Inflammatory bowel disease or active bowel inflammation.
• Symptomatic hypercalcemia requiring continued use of bisphosphonate or denosumab therapy.
• Clinically significant history of liver disease, including viral disease or hepatitis,current alcohol abuse or cirrhosis.
• Known HIV infection.
• Active (chronic or acute) hepatitis C virus (HCV) at screening.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200120, China

Location

Related Publications (1)

• 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.

  PMID: 39721851 DERIVED

MeSH Terms

Interventions

ipatasertib

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 10, 2020
• Study Start: November 3, 2020
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)