- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04341259
A Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Participants With Locally Advanced Or Metastatic Solid Tumors.
May 5, 2023 updated by: Hoffmann-La Roche
A Phase I Study Of The Pharmacokinetics And Safety Of Ipatasertib In Chinese Patients With Locally Advanced Or Metastatic Solid Tumors.
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
12
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Reference Study ID Number: YP40057 https://forpatients.roche.com/
- Phone Number: 888-662-6728 (U.S. and Canada)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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Shanghai City, China, 200120
- Fudan University Shanghai Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Hepatitis B virus (HBV) infection (chronic or acute), defined as having a positive hepatitis B surface antigen (HBsAg) test or a positive quantitative HBV DNA test at screening
- Significant traumatic injury within 3 weeks prior to initiation of ipatasertib treatment.
- Major surgical procedure within 4 weeks prior to initiation of ipatasertib treatment.
- Treatment with chemotherapy, immunotherapy, or biologic therapy as cancer therapy within 3 weeks prior to initiation of ipatasertib treatment.
- Use of strong CYP3A4 inhibitors within 4 weeks prior to initiation of ipatasertib treatment.
- Oral endocrine therapy within 2 weeks prior to initiation of ipatasertib treatment.
- Prior treatment with a PI3-kinase inhibitor in which the patient experienced a Grade >= 3 drug-related adverse event or otherwise would be at increased risk for additional PI3K-related toxicity.
- Palliative radiation to bony metastases within 2 weeks prior to initiation of ipatasertib treatment.
- Radiotherapy (other than palliative radiation to bony metastases) as cancer therapy within 4 weeks prior to initiation of ipatasertib treatment.
- Treatment with an investigational agent within 4 weeks prior to initiation of ipatasertib treatment.
- Unresolved toxicity from prior therapy, except for alopecia and Grade 1 peripheral neuropathy.
- Pregnant or lactating.
- Inability to comply with study and follow-up procedures.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Ipatasertib as a Single Agent
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.
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Participants will receive a 400-mg Ipatasertib dose (two 200-mg tablets) orally (PO) daily (QD) as described above.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC (0-inf) after a single dose and AUC (0-24) after single and multiple doses of Ipatasertib
Time Frame: Up to 25 months
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Up to 25 months
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Maximum plasma concentration (Cmax) of Ipatasertib
Time Frame: Up to 25 months
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Up to 25 months
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Minimum plasma concentration (Cmin) of Ipatasertib after multiple doses of Ipatasertib
Time Frame: Up to 25 months
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Up to 25 months
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Time to maximum plasma concentration (tmax) of Ipatasertib
Time Frame: Up to 25 months
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Up to 25 months
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Terminal half-life (t1/2) of Ipatasertib and GO37220
Time Frame: Up to 25 months
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Up to 25 months
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Apparent clearance (CL/F) of Ipatasertib and GO37220 after single and multiple doses of Ipatasertib
Time Frame: Up to 25 months
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Up to 25 months
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Accumulation ratio at steady state (Rcmax) of Ipatasertib
Time Frame: Up to 25 months
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Accumulation ratio will be calculated as follows: Rcmax = AUC24h,ss/AUC0-24 of Day 1.
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Up to 25 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Up to 25 months
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Assessed by the NCI CTCAE v5.0 criteria.
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Up to 25 months
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Percentage of Participants with Adverse Events leading to Study Treatment Discontinuation, Modification or Interruption
Time Frame: Up to 25 months
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Up to 25 months
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Number of Deaths
Time Frame: Up to 25 months
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Up to 25 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2020
Primary Completion (Actual)
April 6, 2023
Study Completion (Actual)
April 6, 2023
Study Registration Dates
First Submitted
April 8, 2020
First Submitted That Met QC Criteria
April 8, 2020
First Posted (Actual)
April 10, 2020
Study Record Updates
Last Update Posted (Actual)
May 8, 2023
Last Update Submitted That Met QC Criteria
May 5, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YP40057
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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).
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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