Clinical Trials Search
Trastuzumab and Pertuzumab (HP) in Patients with Non-Breast, Non-Gastric/GEJ Cancers with HER2 Amplification
EAY131-J (MATCH)
- Eligibility:Click Here to ViewSubprotocol J eligibility (in addition to master eligibility):
-Patients must have HER2 amplification =7 copy numbers by NGS as determined by the MATCH screening assessment.
-Patients must not have breast cancer, gastric/GEJ/esophageal adenocarcinoma or mixed histology, or gastric/GEJ NOS tumors.
-Patients must not have received prior anti-HER2 therapies, including trastuzumab, pertuzumab, T-DM1, lapatinib, afatinib, neratinib, dacomitinib, canertinib. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase 2 Study of JNJ-42756493 (Erdafitinib) in Patients with Tumors with FGFR Amplifications (EAY131-K1)
EAY131-K1 (MATCH)
- Eligibility:Click Here to View-Patients must fulfill all eligibility criteria outlined in Section 3.1 of MATCH Master Protocol (excluding Section 3.1.6) at the time of registration to treatment step (Step 1, 3, 5, 7).
-Patients must have FGFR Amplification as determined via the MATCH Master Protocol and described in Appendix II.
-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
-Patients must not have known hypersensitivity to JNJ-42756493 (erdafitinib) or compounds of similar chemical or biologic composition.
-Patients with current evidence of corneal or retinal disorder/keratopathy are excluded.
-Patients must not be currently using medications that can elevate serum phosphorous and/or calcium levels.- Patients with a history of Hyperphosphatemia will be excluded.
-Patients may not have received strong inhibitors or potent inducers of CYP3A within 2 weeks before the first dose of study treatment. Patients with inability to discontinue treatment with a strong CYP3A4 and/or CYP2C9 inhibitor or inducer prior to start of treatment are excluded.
-Patients who have previously received treatment with a FGFR-targeted inhibitor are excluded. Such inhibitors include AZD4547, BGJ398, BAY1163877 and LY2874455). Prior non-selective FGFR inhibitor treatment (e.g. Pazopanib, dovitinib, ponatinib, brivanib, lucitanib, lenvatinib) are allowed.
-Patients must not have any history of or current evidence of renal or endocrine alterations of calcium/phosphate homeostasis, or history of or current evidence of extensive tissue calcification (by evaluation of the clinician), including but not limited to, the soft tissue, kidneys, intestine, myocardium and lung with the exception of calcified lymph nodes and asymptomatic vascular calcification per investigators’ judgment.
-Patients with transitional cell carcinoma of the bladder and /or urothelial tract are not eligible. These patients are encouraged to enroll in the ongoing disease-specific studies.
-Patients with impaired renal function (glomerular filtration rate [GFR] < 60 mL/min) are excluded. GFR should be assessed by direct measurement (i.e., creatinine clearance or ethyldediaminetetra-acetate) or, if not available, by calculation from serum/plasma creatinine (Cockcroft-Gault formula).
-Patients with persistent phosphate level > ULN during screening (within 14 days of treatment and prior to Cycle 1 Day 1) and despite medical management are excluded.
-Patients with a history of or current uncontrolled cardiovascular disease as stated below are excluded
-Patients with impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions are excluded. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase 2 Study of JNJ-42756493 (erdafitinib) in Patients with Tumors with FGFR Mutations or Fusions (EAY131-K2)
EAY131-K2 (MATCH)
- Eligibility:Click Here to View
-Patients must fulfill all eligibility criteria outlined in Section 3.1 of MATCH Master Protocol (excluding Section 3.1.6) at the time of registration to treatment step (Step 1, 3, 5, 7).
-Patients must have FGFR Mutation or Fusion as determined via the MATCH Master Protocol and as described in Appendix II
-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
-Patients must not have known hypersensitivity to JNJ-42756493 (erdafitinib) or compounds of similar chemical or biologic composition.
-Patients with current evidence of corneal or retinal disorder/keratopathy are excluded.
-Patients must not be currently using medications that can elevate serum phosphorous and/or calcium levels.
-Patients with a history of hyperphosphatemia will be excluded.
-Patients may not have received strong inhibitors or potent inducers of CYP3A within 2 weeks before the first dose of study treatment. Patients with inability to discontinue treatment with a strong CYP3A4 and/or CYP2C9 inhibitor or inducer prior to start of treatment are excluded.
-Patients who have previously received treatment with a FGFR-targeted inhibitor are excluded. Such inhibitors include AZD4547, BGJ398, BAY1163877 and LY2874455). Prior non-selective FGFR inhibitor treatment (e.g. Pazopanib, dovitinib, ponatinib, brivanib, lucitanib, lenvatinib) are allowed. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of MLN0128 (TAK-228) in Patients with Tumors with mTOR Mutations
EAY131-L (MATCH)
- Eligibility:Click Here to ViewSubprotocol L eligibility (in addition to master eligibility):
-Patients must have a mutation in mTOR as determined by the MATCH screening assessment
-Patients must not have uncontrolled diabetes mellitus.-Patients must not have had prior treatment with other known TORC1/2 inhibitors
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of MLN0128 in Patients with Tumors with TSC1 or TSC2 Mutations
EAY131-M (MATCH)
- Eligibility:Click Here to View
**Effective 07/22/21, Please note that there are no available treatment assignment slots remain.
Subprotocol M eligibility (in addition to master):
-Patients must have a TSC1 or TSC2 mutation as determined by the MATCH screening assessment
-Patients must not have uncontrolled diabetes mellitus
-Patients must not have had prior treatment with other known TORC1/2 inhibitors**To clarify, the language in Section 2.1.9 of the EAY131-M Subprotocol should refer to "P450 (CYP) 3A4, CYP2C9 or CYP2C19," instead of duplicating CYP2C19 twice**
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients with Tumors with PTEN Mutation or Deletion, with PTEN Expression on IHC
EAY131-N (MATCH)
- Eligibility:Click Here to ViewSubprotocol N eligibility (in addition to master eligibility):
-Patients must have PTEN gene mutation/deletion.
-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, RHEB, NF2, NRAS, HRAS, NF1.
-Patients must not have received prior treatment with agents targeting the PI3K beta, AKT, or mTOR pathways
-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. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of PI3K Beta Specific Inhibitor, GSK2636771, in Patients with Tumors with PTEN Loss by IHC
EAY131-P (MATCH)
- Eligibility:Click Here to ViewSubprotocol P eligibility (in addition to master eligibility):
-Patients must have complete loss of cytoplasmic and nuclear PTEN staining on immunohistochemistry as determined by the MATCH PTEN IHC assay performed at MD Anderson. Patients can have any PTEN mutation or deletion status, but MUST have PTEN loss by IHC.
-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, RHEB, NF2, NRAS, HRAS, NF1.
-Patients must not have received prior treatment with agents targeting the PI3K beta, AKT, or mTOR
-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. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Ado-trastuzumab Emtansine in Patients with Tumors with HER2 Amplification (Except Breast and Gastric/Gastro-Esophageal Junction (GEJ) Adenocarcinomas)
EAY131-Q (MATCH)
- Eligibility:Click Here to View
Subprotocol Q Eligibility (in addition to master):
-Patients’ tumor sample must have HER2 amplification > 7 based on targeted custom Ampliseq panel on the Ion Torrent PGM.
-Patients will be allowed if on anticoagulation (except warfarin and other coumarin derivatives) or on aspirin 81 mg by mouth daily. However, patients will not be allowed if on long acting anti-platelet agents such as clopidogrel.
-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 ECHO/MUGA within 4 weeks prior to treatment assignment and must not have a left ventricular ejection fraction (LVEF) < 50% to be eligible.
-Patients with a diagnosis of Breast cancer or gastric/GEJ cancer will be excluded.
-Patients must not have known hypersensitivity to ado-trastuzumab emtansine or compounds of similar chemical or biologic composition.
-Patient must not have had any of the prior therapies: Trastuzumab, Pertuzumab, Ado-trastuzumab emtansine, Margetuximab, PF-05280014 (Pfizer, Trastuzumab Biosimilar), CT-P6 (Celltrion, Trastuzumab Biosimilar), ABP-980 (Amgen, Trastuzumab Biosimilar) - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of Trametinib in Patients with BRAF Fusions, or with Non-V600E, Non-V600K BRAF Mutations
EAY131-R (MATCH)
- Eligibility:Click Here to View
Subprotocol R Eligibility (in addition to master):
-Patients must have a BRAF non-V600 mutation or BRAF fusion as identified via the MATCH Master Protocol.
-Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have NONE of the following cardiac criteria:
--Clinically important abnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block).
--Treatment-refractory hypertension defined as a blood pressure of systolic >140 mmHg and/or diastolic >90 mmHg which cannot be controlled by anti-hypertensive therapy
-Patients with a history of interstitial lung disease or pneumonitis are excluded
-Patients must have an ECHO/MUGA within 4 weeks prior to treatment assignment and must not have a left ventricular ejection fraction (LVEF) < the institutional lower limit of normal (LLN).
-Patients must not have known hypersensitivity to trametinib or compounds of similar chemical or biologic composition or to dimethyl sulfoxide (DMSO).
-Patients must not have a history or current evidence/risk of retinal vein occlusion (RVO).
-Patients who previously received MEK inhibitors (including, but not limited to, trametinib, binimetinib, cobimetinib, selumetinib, RO4987655 (CH4987655), GDC-0623 and pimasertib) will be excluded.
-Patients who previously received monoclonal antibody therapy (eg. ipilimumab, nivolumab, pembrolizumab and others) must have stopped the prior therapy for 8 or more weeks before starting on trametinib. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Phase II Study of Trametinib in Patients with Tumors with NF1 mutations
EAY131-S1 (MATCH)
- Eligibility:Click Here to View
Subprotocol S1 eligibility (in addition to master eligibility):
-Patients must have deleterious inactivating mutations of NF-1 by the MATCH NGS assay.
-Patients who previously received MEK inhibitors (including, but not limited to, trametinib, binimetinib, cobimetinib, selumetinib, RO4987655 (CH4987655), GDC-0623 and pimarsertib) will be excluded.
-Patients who previously received monoclonal antibody therapy (eg. ipilimumab, nivolumab, pembrolizumab and others) must have stopped the prior therapy for 8 or more weeks before starting on trametinib.
-Patients with glioblastoma must have histologically or radiographically confirmed recurrent or progressive WHO Grade 4 glioma (glioblastoma). - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.