Testing Ipatasertib as Potentially Targeted Treatment in Cancers With AKT Genetic Changes (MATCH - Subprotocol Z1K)
NCT ID: NCT06400251
Last Updated: 2025-11-20
Study Results
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View full resultsBasic Information
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ACTIVE_NOT_RECRUITING
PHASE2
35 participants
INTERVENTIONAL
2019-08-08
2025-12-31
Brief Summary
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Detailed Description
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I. To evaluate the proportion of patients with objective response (OR) to targeted study agent(s) in patients with advanced refractory cancers/lymphomas/multiple myeloma.
SECONDARY OBJECTIVES:
I. To evaluate the proportion of patients alive and progression free at 6 months of treatment with targeted study agent in patients with advanced refractory cancers/lymphomas/multiple myeloma.
II. To evaluate time until death or disease progression. III. To identify potential predictive biomarkers beyond the genomic alteration by which treatment is assigned or resistance mechanisms using additional genomic, ribonucleic acid (RNA), protein and imaging-based assessment platforms.
IV. To assess whether radiomic phenotypes obtained from pre-treatment imaging and changes from pre- through post-therapy imaging can predict objective response and progression free survival and to evaluate the association between pre-treatment radiomic phenotypes and targeted gene mutation patterns of tumor biopsy specimens.
OUTLINE: Patients receive ipatasertib orally (PO) once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo computed tomography (CT) or magnetic resonance imaging (MRI) during screening and on study, as well as during follow-up as clinically necessary. Patients undergo biopsies and blood sample collection on study.
After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 1 year.
THE MATCH SCREENING TRIAL:
Please see NCT02465060 for information on the MATCH Screening Protocol and applicable documents.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (ipatasertib)
Patients receive ipatasertib 400 mg PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI during screening and on study, as well as during follow-up as clinically necessary. Patients undergo biopsies and blood sample collection on study.
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Ipatasertib
Given PO
Magnetic Resonance Imaging
Undergo MRI
Interventions
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Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Computed Tomography
Undergo CT scan
Ipatasertib
Given PO
Magnetic Resonance Imaging
Undergo MRI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have an AKT mutation as determined via the MATCH Master Protocol
* Patients with breast cancer are excluded
* Patients with castration-resistant prostate cancer should maintain castrate levels of testosterone (i.e., with gonadotropin-releasing hormone (GnRH) agonists or through surgical castration). Patients are allowed to continue abiraterone acetate/prednisone with Ipatasertib if the patient just progressed on abiraterone acetate/prednisone
* Patients must not have known hypersensitivity to Ipatasertib or compounds of similar chemical or biologic composition
* Patients with known KRAS, NRAS, HRAS, or BRAF mutations are not eligible for this protocol, as these mutations may lead to limited response due to resistance
Exclusion Criteria
* Patients not on a stable dose of oral hypoglycemic medication for \>= 4 weeks and appropriate diet
* Insulin required for routine diabetic management and control
* More than two oral hypoglycemic medications required for routine diabetic management and control
* Glycosylated hemoglobin (hemoglobin A1C) \>= 7.5%
* Prior PI3K and mTOR inhibitors are allowed, including in the metastatic setting. Prior AKT inhibitors are excluded
* Patients with a history of inflammatory bowel diseases (Crohn's disease and ulcerative colitis) or active diverticulitis are not eligible
* Patients may not have received strong inhibitors or potent inducers or substrates of CYP3A4/5 within 2 weeks before the first dose of study treatment (3 weeks for St John's wort)
* In addition to the patient contraception requirements outlined in EAY131 MATCH Master Protocol, male patients must also refrain from donating sperm for the duration of study participation, and for 4 months after completion of study
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Responsible Party
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Principal Investigators
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Kevin M Kalinsky
Role: PRINCIPAL_INVESTIGATOR
ECOG-ACRIN Cancer Research Group
Locations
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ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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NCI-2024-01194
Identifier Type: REGISTRY
Identifier Source: secondary_id
EAY131-Z1K
Identifier Type: OTHER
Identifier Source: secondary_id
EAY131-Z1K
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2024-01194
Identifier Type: -
Identifier Source: org_study_id
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