Status:
ACTIVE_NOT_RECRUITING
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This phase II MATCH treatment trial identifies the effects of AZD5363 in patients whose cancer has a genetic change called AKT mutation. AZD5363 may block AKT, which is a protein needed for cancer cel...
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. SECONDAR...
Eligibility Criteria
Inclusion
- Patients must have met applicable eligibility criteria in the Master MATCH Protocol prior to registration to treatment subprotocol
- Patients must have an AKT mutation as determined via the MATCH Master Protocol
- Patients with hormone receptor positive, defined as estrogen receptor and/or progesterone receptor \> 1% by immunohistochemistry, AND HER2 negative unresectable breast cancer, with no overexpression by immunohistochemistry (IHC) or amplification by in-situ hybridization, are allowed to continue fulvestrant or an aromatase inhibitor (anastrozole, letrozole, exemestane) with AZD5363 if patient just progressed on this anti-estrogen therapy. Gonadotrophin releasing hormone (GnRH) agonists (such as leuprolide or goserelin) are allowed. For instance, if the last treatment was letrozole plus goserelin, the patient is allowed to continue the letrozole plus goserelin with AZD5363
- NOTE: Selective estrogen receptor modulators (SERMs), such as tamoxifen or toremifene, are not allowed, given concerns about CYPD26 and CYP3A4 metabolism, respectively
- Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block)
- Patients with diabetes or risk for hyperglycemia are eligible. 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)
- Insulin required for routine diabetic management and control
- More than two oral hypoglycemic medications required for routine diabetic management and control
Exclusion
- Patients must not have known hypersensitivity to AZD5363 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 may not have received treatment with another inhibitor of PI3K, AKT or mTOR in the neoadjuvant, adjuvant or metastatic setting with the exception of FDA approved rapalogs. Patients with metastatic cancer, who received PI3K/AKT/mTOR inhibitors on short preoperative window trials (treatment for 4 weeks or less) will be eligible if the treatment was over 6 months prior to registration
- Patients may not have received strong inhibitors or potent inducers or substrates of CYP3A4 or substrates of CYP2D6 within 2 weeks before the first dose of study treatment (3 weeks for St John's Wort)
Key Trial Info
Start Date :
May 31 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04439123
Start Date
May 31 2016
End Date
March 19 2026
Last Update
November 18 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States, 19103