Clinical Trials Search
Phase II Study of AZD4547 in Patients with Tumors with Aberrations in the FGFR Pathway
EAY131-W (MATCH)
- Eligibility:Click Here to ViewSubprotocol W eligibility (in addition to master eligibility):
-Patients must have FGFR 1-3 amplification, mutation or translocation as determined by the MATCH screening assessment.
-Patients with squamous cell lung carcinoma, gastric cancer, gastroesophageal junction cancer that harbor FGFR amplifications will be excluded.
--Mutations or fusions of FGFR 1-3 in the above mentioned histologies will still be eligible for the trial.
-Patients must not have received prior FGFR specific inhibitors (e.g. BGJ398, erdafitinib, BAY1163877, LY2874455). Prior non-selective FGFR inhibitor treatment (e.g. Pazopanib, dovitinib, ponatinib, brivanib, lucitanib, lenvatinib) will be 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 Dasatinib in Patients with Tumors with DDR2 Mutations
EAY131-X (MATCH)
- Eligibility:Click Here to ViewSubprotocol X eligibility (in addition to master eligibility):
-Patients must have one of the following missense mutation in DDR2: S768R, I638F, L239R.
-Patients with prior use of dasatinib will be excluded.
-Dasatinib should NOT be given in the presence of STRONG CYP 3A4 inhibitors/inducers.
-Dasatinib should NOT be given in the presence of H2-Antagonists or Proton Pump Inhibitors. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
AZD5363 in Patients with Tumors with AKT Mutations
EAY131-Y (MATCH)
- Eligibility:Click Here to ViewSubprotocol Y eligibility (in addition to master eligibility):
-Patients must have an AKT mutation as determined by the MATCH screening assessment.
-Patients with ER and/or PR positive AND HER2 negative unresectable breast cancerare allowed to continue fulvestrant or an aromatase inhibitor with AZD5363 if patient just progressed on this anti-estrogen therapy. GnRH agonists are allowed. However,
SERMs, such as tamoxifen or toremifene, are not allowed
-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. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Binimetinib in Patients with Tumors (Other Than Melanoma) with NRAS Mutations
EAY131-Z1A (MATCH)
- Eligibility:Click Here to ViewSubprotocol Z1A eligibility (in addition to master eligibility):
-Patients must have NRAS mutation in codon 12, 13, 61 as determined by the MATCH screening assessment.
-Patients with melanoma are excluded.
-Patients must not have any active central nervous system (CNS) lesionand/or leptomeningeal metastases.
--Patients treated with stereotactic radiotherapy or surgery are eligible if the patient remained without evidence of CNS disease progression for at least 3 months. Patients must be off corticosteroid therapy for at least 3 weeks.
-Patients who have received prior MEK inhibitors are excluded. - 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 Palbociclib (PD-0332991) in Patients with Tumors with CDK4 or CDK6 Amplification and Rb Protein Expression by IHC
EAY131-Z1C (MATCH)
- Eligibility:Click Here to ViewSubprotocol Z1C eligibility (in addition to master):
-Patients must have CDK4 amplification or CDK6 amplification and tumor Rb protein expression by immunohistochemistry as determined by the MATCH screening assessment
-Patients must not have breast cancer, mantle cell lymphoma, myeloma, or liposarcoma
-Patients must not have received prior therapy with a CDK4 or CDK6 inhibitor - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
Nivolumab in Patients with Tumors with Mismatch Repair Deficiency (Excluding Colorectal Cancer)
EAY131-Z1D (MATCH)
- Eligibility:Click Here to ViewSubprotocol Z1D eligibility (in addition to master eligibility):
-Patients must have mismatch repair deficiency as determined by the MATCH screening assessment.
-No prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-OX-40, anti-CD40 or anti-CTLA-4 antibodies (or any other antibody targeting T cell co-regulatory pathways).
-Patients with colorectal cancer are excluded.
-Must not have received any of the following therapies within four weeks prior to the first dose of the study drug: IL-2, interferon, or other non-study immunotherapy regimens or immunosuppressive agents.The master protocol eligibility criterion regarding wash-out period from prior therapy is also applicable.
-Must not have received growth factors, including but not limited to granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration. Use of such agents while on study is also prohibited.
-Must not have a history of any autoimmune disease
-Must not be on supplemental home oxygen.
-Patients with a requirement for steroid treatment or other immunosuppressive treatment: Patients should be excluded if they have a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalents) within 14 days of study drug administration. - Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.
LOXO-101 in Patients with Tumors with NTRK Fusions
EAY131-Z1E (MATCH)
- Eligibility:Click Here to ViewSubprotocol Z1E eligibility (in addition to master):
-Patients must have a malignancy harboring an NTRK1, NTRK2 or NTRK3 gene fusion, as determined by the MATCH screening assessment
-Patients who have previously received treatment with a TRKA, TRKB, or TRKC inhibitor are excluded. - 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 Copanlisib in Patients with Tumors with PIK3CA Mutations (PTEN Loss Allowed) (EAY131-Z1F)
EAY131-Z1F (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 PIK3CA mutation as determined via the MATCH Master Protocol and described in Appendix I.
-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 copanlisib or compounds of similar chemical or biologic composition.
-Patients must not have had prior therapy with copanlisib or other PI3K inhibitors, AKT inhibitors or mTOR inhibitors.
-Patients must not have activating KRAS mutations.
-Patients must not have HER2 positive (3+ by IHC or FISH ratio ? 2) breast cancer.
-Patients must not have indolent NHL (follicular lymphoma, SLL/CLL, LPL, marginal zone lymphoma) or DLBCL (diffuse large B cell lymphoma).
-Patients must not be on strong inhibitors or inducers of CYP3A4 within two weeks prior to start of study treatment and for the duration of study treatment. - 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 Copanlisib in Patients with Tumors with PTEN Loss by IHC and any PTEN Sequencing Result (EAY131-Z1G)
EAY131-Z1G (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 complete loss of cytoplasmic and nuclear PTEN by immunohistochemistry as determined via the MATCH Master Protocol and described in Appendix I. Patients can have any PTEN mutation or deletion status, but MUST have PTEN loss by IHC.
-Patients must not have co-existing aberrations in the MAPK or PI3K/MTOR pathways as determined by the MATCH screening assessment in NRAS, HRAS, KRAS, BRAF, PIK3CA, AKT or mTOR.
-Patients must have an electrocardiogram (ECG) within 8 weeks prior to treatment assignment and must have no clinically importantabnormalities in rhythm, conduction or morphology of resting ECG (e.g. complete left bundle branch block, third degree heart block).
-Patients must not have known hypersensitivity to copanlisib or compounds of similar chemical or biologic composition.
-Patients must not have had prior treatment with copanlisib or other PI3K inhibitors, AKT inhibitors or mTOR inhibitors.
-Patients must not be on strong inhibitors or inducers of CYP3A4 within two weeks prior to start of study treatment and for the duration of study treatment.
-Patients must not have uncontrolled hypertension defined as SBP greater than 160 mmHg or diastolic BP greater than 100 mmHg or use of more than 2 anti-hypertensive medications. - 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 Copanlisib in Patients with Tumors with Deleterious PTEN Sequencing Result and PTEN Expression by IHC (EAY131-Z1H)
EAY131-Z1H (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 mutations in the PTENgene with 1% or more expression of PTEN by IHC as determined via the MATCH Master Protocol and as described in Appendix I.
-Patients must not have co-existing aberrations in the MAPK or PI3K/MTOR pathways as determined by the MATCH screening assessment in NRAS, HRAS, KRAS, BRAF, PIK3CA, AKT or mTOR.-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 copanlisib or compounds of similar chemical or biologic composition.
-Patients must not require prior treatment with copanlisib or other PI3K inhibitors, AKT inhibitors or mTOR inhibitors.
Patients must not be on strong inhibitors or inducers of CYP3A4 within two weeks prior to start of study treatment and for the duration of study treatment.
-Patients must not be on anti-arrhythmic therapy other than digoxin or beta-blockers.
- Consent forms:You must be logged in to view the documents.
- Protocols:You must be logged in to view the documents.