Status:
ACTIVE_NOT_RECRUITING
Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Genetic Changes (MATCH-Subprotocol N)
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 GSK2636771 in patients whose cancer has a genetic change called PTEN mutation or deletion. GSK2636771 may block a protein called PI3K-beta...
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 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 must have PTEN gene mutation/deletion
- There must be evidence of PTEN expression by immunohistochemistry (IHC) (any amount of staining will be considered positive for expression)
- Patients with complete loss of PTEN by IHC, regardless of PTEN mutations/deletion status, will be enrolled into MATCH subprotocol EAY131-P, not this subprotocol (EAY131-N)
- Patients must have hemoglobin \>= 9 g/dL
- Patients must have a serum creatinine that =\< 1.5 x upper limit of normal (ULN) or have a 24-hour creatinine clearance of \>= 50 mL/min
Exclusion
- Patients must not have known hypersensitivity to GSK2636771 or compounds of similar chemical or biologic composition.
- Patients must not have tumors harboring co-existing aberrations activating the PI3K/MTOR and MAPK pathways, such as PIK3CA, PIK3R1, BRAF, KRAS and AKT1, TSC1/2, mTOR, NF2, NRAS, HRAS, NF1
- Patients must not have received prior treatment with agents targeting the PI3K beta, AKT, or mTOR pathways:
- This includes (but is not limited to):
- mTOR inhibitors: temsirolimus, everolimus, ridaforolimus, sirolimus, salirasib, CC-223, INK128, DS-3078, CC-115, AZD-2014
- Dual PI3K/mTOR inhibitors: BEZ235, XL-765, GDC 0980, PF-04691502, GSK 2126458, Quinacrine, PKI-587, P-P7170, LY3023414, GDC 0084, DS 7423, CBLC-137
- Pan-PI3K inhibitors: BKM-120 (buparlisib), PX-866, XL-147, GDC-0941 (pictilisib), BAY-806946, ZSTK-474, WX 037, SRX5000, SRX2523, AMG511, PQR308, BAY 94-9343
- PI3K inhibitors with beta isoform activity: prior GSK2636771 is not allowed, nor is GS-9820, PQR3XX, KAR4139
- The following treatments are allowed:
- BYL719 (PI3Kalpha inhibitor)
- GDC-0032 (PI3Kalpha inhibitor)
- INK1117 (PI3Kalpha inhibitor)
- Idelalisib (PI3Kdelta inhibitor)
- IPI-125 (PI3K gamma delta inhibitor)
- TGR1202 (PI3Kdelta inhibitor)
- SRX2558 (PI3Kdelta inhibitor)
- RP6530 (PI3K gamma delta inhibitor)
- PWT143 (PI3Kdelta inhibitor)
- IPI443 (PI3K gamma delta inhibitor)
- GNE293 (PI3Kdelta inhibitor)
- Patients with a history of interstitial lung disease or pneumonitis are excluded
- Patients must not have any congenital platelet function defects and cannot be on any of the following anti-platelet drugs: clopidogrel, ticlopidine, prasugrel, that act at platelet purinergic receptors
- Any need for starting anti-platelet therapy in a patient enrolled to this arm will have to be evaluated by the subprotocol chair
Key Trial Info
Start Date :
May 5 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04439149
Start Date
May 5 2016
End Date
December 31 2026
Last Update
November 21 2025
Active Locations (1)
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1
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States, 19103