Clinical Trials Search
Phase 2 study of crizotinib in patients with tumors with MET exon 14 deletion
EAY131-C2 (MATCH)
- Eligibility:Click Here to ViewSubprotocol C2 eligibility (in addition to Master eligibility):
-Patient must have MET exon 14 skipping as defined by the MATCH NGS assay.
-Patient must not have had any of the following prior therapies: AMG 337, BMS 777607, Cabozantinib (XL184), Crizotinib (PF02341066), EMD1214063, Foretinib (GSK1363089) (XL880), Golvatinib (E7050), IncB28060 (INC280), JNJ 8877605, MGCD265, MK2461, MSC2156119J, PF 04217903, SGX523, Tivantinib (ARQ197) or any other novel MET TKI with any MET inhibitory activity IC50 < 1 uM. Prior anti-HGF or anti-MET antibodies are acceptable. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
AZD9291 in Patients with Tumors Having EGFR T790M Mutations (Except Non-Small Cell Lung Cancer) or Rare Activating Mutations of EGFR
EAY131-E (MATCH)
- Eligibility:Click Here to View
Subprotocol E Eligibility (in addition to master):
-Patients must have either:
--Any malignancy other than non-small cell lung cancer and have EGFR T790M identified in their tumor, with or without an activating mutation OR
--Any malignancy harboring any of the following mutations: EGFR G719A, G719C, G719D, G719S EGFR L861Q, S786I or an EGFR exon 19 in frame insertion mutation
-Patients must have an 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 have an ECHO/MUGA within 4 weeks prior to treatment assignment and must not have a LVEF < institutional LLN.
-Patients must not have known hypersensitivity to AZD9291 or compounds of similar chemical or biologic composition.
-Patient must not have received AZD9291, WZ4002, CO-1686, HM61713, EGF816 or ASP8273 previously.
-Patients known to harbor germline EGFR T790M mutations are excluded from the study. Prospective testing for germline mutations is not required. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Crizotinib in Patients with Tumors (Other Than Adenocarcinoma of Lung or ALCL) with ALK Translocations
EAY131-F (MATCH)
- Eligibility:Click Here to View
Subprotocol F Eligibility (in addition to master):
-Patients must have an ALK rearrangement as determined by the MATCH screening assessment.
-Patients must not have non small cell lung cancer or ALCL.
-Patients with a history of interstitial lung disease or pneumonitis are excluded.
-Patients must have an 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 crizotinib or compounds of similar chemical or biologic composition.
-Patients must not have had prior ALK-targeted inhibitors, including crizotinib, ceritinib, alectinib, AP26113, TSR-011, X-396, RXDX-101, CEP-37440, PF-06463922Patients must not have had brain metastases unless 1) treated and neurologically stable for at least 2 weeks, or 2) untreated, asymptomatic, and treatment is not indicated. Steroids are permitted if doses are stable (or tapering) for 2 weeks prior to study enrollment. - 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 Crizotinib in Patients with ROS1 Translocations (Other Than Patients with Non-Small Cell Lung Cancer)
EAY131-G (MATCH)
- Eligibility:Click Here to View
Subprotocol G Eligibility (in addition to master):
-Patients must be positive for translocation or inversion events involving the ROS1 gene as detected on the MATCH NGS assay
-Patients must not have adenocarcinoma of the lung.
-Patients with a history of interstitial lung disease or pneumonitis are excluded.
-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 crizotinib or compounds of similar chemical or biologic composition.
-Patients must not have had prior therapy with any ROS1 inhibitor including crizotinib, ceritinib, foretinib, cabozantinib, AP26113, ASP3026, WZ-5-126, TAE684, KIST301072, KIST301080, AZD1480, PF-06463922, RXDX-101 and PF-3922 - 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 Dabrafenib and Trametinib in Patients with Tumors with BRAF V600E or V600K Mutations (Excluding Melanoma and Thyroid Cancer)
EAY131-H (MATCH)
- Eligibility:Click Here to View
Subprotocol H Eligibility (in addition to master)
-Patients must have a BRAF V600E or, V600K, V600R or V600D mutation as identified via the MATCH Master Protocol.
-Patients with a diagnosis of metastatic melanoma from a cutaneous, acral, mucosal, or unknown primary site are excluded.
-Patients with a diagnosis of papillary thyroid cancer are excluded.
-Patients with a diagnosis of colorectal cancer are excluded
-Patients must have an ECHO/MUGA within 4 weeks prior to treatment assignment and must not have a LVEF < the institutional LLN.
-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 not have known hypersensitivity to dabrafenib and 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 BRAF inhibitors (including, but not limited to, dabrafenib (Tafinlar), vemurafenib (PLX-4720) (Zelboraf), RAF265, LGX818 (encorafenib), RO5212054 (PLX3603), ARQ 736, XL281 (BMS-908662), CEP-32496, and the BRAF/MEK dual inhibitor RO5126766) will be excluded.
-Patients with prior exposure to dabrafenib or trametinib on another treatment subprotocol of the MATCH trial are excluded.
-Patients who previously received monoclonal antibody therapy (eg. Ipilimumab and others) must have stopped the prior therapy for 8 or more weeks before starting on trametinib and dabrafenib.
-Patients with a history of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) infection are excluded.
-Patients with history of RAS mutation-positive tumors are not eligible regardless of interval from the current study. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
GDC-0032 (taselisib) in Patients with Tumors (other than breast cancer) with PIK3CA mutation but without KRAS mutation or PTEN loss
EAY131-I (MATCH)
- Eligibility:Click Here to ViewSubprotocol I eligibility (in addition to master eligibility):
-Patients must have a PIK3CA mutation detected in their tumor sample as determined by the MATCH screening assessment.
-Patients must not have breast cancer.
-Patients with squamous cell carcinoma of the lung who have PIK3CA mutations are not eligible.
-Patients must not have KRAS mutations, and/or PTEN mutation or loss, detected in the tumor sample as determined by the MATCH screening assessment.
-Patients must not have had prior therapy with a PI3K inhibitor or PI3K/mTOR inhibitor.
-Patients must not have had prior therapy with an Akt inhibitor.
-Patients with prior treatment with an mTOR inhibitor are acceptable.
-Patients must not have current dyspnea at rest or require any daily supplemental oxygen - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
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.