Status:
ACTIVE_NOT_RECRUITING
Testing GSK2636771 as a Potential Targeted Treatment in Cancers With PTEN Loss of Expression (MATCH-Subprotocol P)
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 complete loss of PTEN expression. GSK2636771 may block a protein called PI3K-beta, which may be ...
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 complete loss of cytoplasmic and nuclear PTEN staining on immunohistochemistry as determined by the MATCH PTEN immunohistochemistry (IHC) assay performed at MD Anderson. Patients can have any PTEN mutation or deletion status, but MUST have PTEN loss by IHC
- Patients must have hemoglobin \>= 9 g/dL
- Patients must have a serum creatinine that is \< 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:
- 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 previous 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 :
March 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04439188
Start Date
March 21 2016
End Date
December 31 2026
Last Update
November 19 2025
Active Locations (1)
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1
ECOG-ACRIN Cancer Research Group
Philadelphia, Pennsylvania, United States, 19103