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Trial Title:
Testing Ipatasertib as Potentially Targeted Treatment in Cancers With AKT Genetic Changes (MATCH - Subprotocol Z1K)
NCT ID:
NCT06400251
Condition:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma
Conditions: Official terms:
Lymphoma
Neoplasms
Multiple Myeloma
Ipatasertib
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biopsy
Description:
Undergo biopsy
Arm group label:
Treatment (ipatasertib)
Other name:
BIOPSY_TYPE
Other name:
Bx
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood sample collection
Arm group label:
Treatment (ipatasertib)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT scan
Arm group label:
Treatment (ipatasertib)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Ipatasertib
Description:
Given PO
Arm group label:
Treatment (ipatasertib)
Other name:
GDC 0068
Other name:
GDC-0068
Other name:
GDC0068
Other name:
RG 7440
Other name:
RG-7440
Other name:
RG7440
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (ipatasertib)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Summary:
This phase II MATCH treatment trial tests how well ipatasertib works in treating patients
with cancer that has certain genetic changes called AKT mutations. Ipatasertib is in a
class of medications called protein kinase B (AKT) inhibitors. It may stop the growth of
cancer cells and may kill them.
Detailed description:
PRIMARY OBJECTIVE:
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol
EAY131/ NCI-2015-00054 prior to registration to treatment subprotocol
- 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
- Patients with diabetes or risk for hyperglycemia are eligible. Patients with
diabetes mellitus should be on a stable dose of oral hypoglycemic agents for >= 4
weeks and appropriate diet. Patients with diabetes mellitus may enter the study
unless any of the following exclusion criteria are fulfilled:
- Baseline fasting glucose value of > 8.9 mmol/L or 160 mg/dL (fasting is defined
as no calorific intake for at least 8 hours)
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
ECOG-ACRIN Cancer Research Group
Address:
City:
Philadelphia
Zip:
19103
Country:
United States
Start date:
July 24, 2019
Completion date:
March 3, 2025
Lead sponsor:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
National Cancer Institute (NCI)
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06400251
