Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ensartinib · 1 trial · 45 indications
Match rate will be calculated as the percent of eligible patients who have an actionable mutation of interest and are matched to at least one of the subprotocols, and confidence intervals will be constructed using the Wilson score interval method. Patients enrolled on or after Amendment 4 will not be included in this analysis as screening of unselected patients will no longer be conducted.
| Arm | Type | Description |
|---|---|---|
| Subprotocol A (NTRK1, NTRK2, or NTRK3 gene fusion) | EXPERIMENTAL | Patients with a NTRK1, NTRK2, or NTRK3 gene fusion receive larotrectinib sulfate PO or via nasogastric- or gastric-tube BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. |
| Subprotocol B (FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation) | EXPERIMENTAL | Patients with a FGFR1, FGFR2, FGFR3, or FGFR4 gene mutation receive erdafitinib PO QD on days 1-28 of each cycle. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study. |
| Subprotocol C (EZH2, SMARCB1, or SMARCA4 gene mutation) | EXPERIMENTAL | Patients with an EZH2, SMARCB1, or SMARCA4 gene mutation receive tazemetostat PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. |
| Subprotocol D (TSC1, TSC2, or PI3K/mTOR gene mutation) | EXPERIMENTAL | Patients with a TSC1, TSC2, or PI3K/mTOR gene mutations receive PI3K/mTOR inhibitor LY3023414 PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. |
| Subprotocol E (activating MAPK pathway gene mutation) | EXPERIMENTAL | Patients with an activating MAPK pathway gene mutation receive selumetinib sulfate PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. |
| Subprotocol F (ALK or ROS1 gene alteration) | EXPERIMENTAL | Patients with an ALK or ROS1 gene alteration receive ensartinib PO BID on days 1-28. Cycles repeat every 28 days for 2 years (up to 26 cycles) in the absence of disease progression or unacceptable toxicity. Patients undergo an x-ray, CT scan, MRI, PET scan, radionuclide imaging, and/or bone scan, as well as a bone marrow aspiration and/or biopsy during screening and on study. Patients also undergo blood sample collection on study. |
| Subprotocol G (BRAF V600 gene mutation) | EXPERIMENTAL | Patients with a BRAF V600 gene mutation receive vemurafenib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. |
| Subprotocol H (ATM, BRCA1, BRCA2, RAD51C, RAD51D mutations) | EXPERIMENTAL | Patients deleterious ATM, BRCA1, BRCA2, RAD51C, or RAD51D gene mutations receive olaparib PO BID on days 1-28. Cycles repeat every 28 days for 2 years in the absence of disease progression or unacceptable toxicity. |
| Subprotocol I (Rb positive, alterations in cell cycle genes) | EXPERIMENTAL | Patients with Rb positive advanced solid tumors, non-Hodgkin lymphoma, or histiocytic disorders with activating alterations in cell cycle genes receive palbociclib PO QD on days 1-21. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. |
| Subprotocol J (MAPK pathway mutations) | EXPERIMENTAL | Patients with MAPK pathway mutations receive ulixertinib PO BID. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. |
| Subprotocol K (IDH1 gene mutation) | EXPERIMENTAL | Patients with IDH1 gene mutations receive ivosidenib PO QD. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. |
| Subprotocol M (HRAS gene alterations) | EXPERIMENTAL | Patients receive tipifarnib PO or via nasogastric or gastric tube BID on days 1-7 and 15-21. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. |
| Subprotocol N (activating RET mutations) | EXPERIMENTAL | Patients with activating RET gene alterations receive selpercatinib PO BID on days 1-28. Treatment repeats every 28 days for up to 26 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Patients may also undergo PET, CT, MRI, PET/CT, PET/MRI, and/or CT/MRI, scintigraphy, and x-ray imaging throughout the trial. |
| Name | Type | Description |
|---|---|---|
| Biopsy Procedure | PROCEDURE | Undergo biopsy |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration and Biopsy | PROCEDURE | Undergo a bone marrow and/or biopsy |
| Bone Scan | PROCEDURE | Undergo a bone scan |
| Computed Tomography | PROCEDURE | Undergo CT, PET/Ct, and/or CT/MRI |
| Ensartinib | DRUG | Given PO |
| Erdafitinib | DRUG | Given PO |
| Ivosidenib | DRUG | Given PO |
| Laboratory Biomarker Analysis | OTHER | Undergo molecular analysis |
| Larotrectinib Sulfate | DRUG | Given PO or via nasogastric- or gastric-tube |
| Magnetic Resonance Imaging | PROCEDURE | Undergo MRI, PET/MRI, and/or CT/MRI |
| Mutation Carrier Screening | PROCEDURE | Undergo tumor tissue mutation screening |
| Olaparib | DRUG | Given PO |
| Palbociclib | DRUG | Given PO |
| Pharmacological Study | OTHER | Correlative studies |
| Positron Emission Tomography | PROCEDURE | Undergo PET, PET/CT, and/or PET/MRI |
| Radionuclide Imaging | PROCEDURE | Undergo radionuclide imaging |
| Samotolisib | DRUG | Given PO |
| Selpercatinib | DRUG | Given PO |
| Selumetinib Sulfate | DRUG | Given PO |
| Tazemetostat | DRUG | Given PO |
| Tipifarnib | DRUG | Given PO or via nasogastric or gastric tube |
| Ulixertinib | DRUG | Receive PO |
| Vemurafenib | DRUG | Given PO |
| X-Ray Imaging | PROCEDURE | Undergo an x-ray |
Inclusion Criteria: * ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients must be \>= 12 months and =\< 21 years of age at the time of study enrollment * ELIGIBILITY CRITERIA FOR ENROLLMENT ONTO APEC1621SC: Patients with recurrent or refractory solid tumors, including non-Hodgkin lymphoma...