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Solid TumorsPhase 1NCT04341259

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

A Phase 1 study testing Ipatasertib in people with Solid Tumors, run by Hoffmann-La Roche at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
Ipatasertib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
3 Nov 2020to 6 Apr 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, 200120

Other trials in China

About this study

Official title: 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.

Conditions
Solid Tumors
Being tested
Ipatasertib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IpatasertibDrug

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

Study groups in NCT04341259
Study groupRoleWhat they receive
Ipatasertib as a Single AgentExperimentalParticipants 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.
Receives: Drug: Ipatasertib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC (0-inf) after a single dose and AUC (0-24) after single and multiple doses of Ipatasertib

    Measured: Up to 25 months

  2. Maximum plasma concentration (Cmax) of Ipatasertib

    Measured: Up to 25 months

  3. Minimum plasma concentration (Cmin) of Ipatasertib after multiple doses of Ipatasertib

    Measured: Up to 25 months

  4. Time to maximum plasma concentration (tmax) of Ipatasertib

    Measured: Up to 25 months

  5. Terminal half-life (t1/2) of Ipatasertib and GO37220

    Measured: Up to 25 months

  6. Apparent clearance (CL/F) of Ipatasertib and GO37220 after single and multiple doses of Ipatasertib

    Measured: Up to 25 months

  7. Accumulation ratio at steady state (Rcmax) of Ipatasertib

    Accumulation ratio will be calculated as follows: Rcmax = AUC24h,ss/AUC0-24 of Day 1.

    Measured: Up to 25 months

Secondary outcomes (3)

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

    Assessed by the NCI CTCAE v5.0 criteria.

    Measured: Up to 25 months

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

    Measured: Up to 25 months

  3. Number of Deaths

    Measured: Up to 25 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Apr 2020
  2. Study start3 Nov 2020
  3. Primary completion6 Apr 2023
  4. Study completion6 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04341259
Sponsor's protocol ID
YP40057
Status last verified
May 2023
First submitted
8 Apr 2020
Last updated
8 May 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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).

Publications

  • 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.

    PubMed 39721851

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ipatasertib in people with Solid Tumors, run by Hoffmann-La Roche at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC (0-inf) after a single dose and AUC (0-24) after single and multiple doses of Ipatasertib (time frame: Up to 25 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04341259, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2023.

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