Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer
NCT ID: NCT03992456
Last Updated: 2024-05-21
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
PHASE2
Total Enrollment
12 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-04-24
Study Completion Date
2024-10-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This phase II trial studies how well retreatment with panitumumab works compared to standard of care regorafenib or trifluridine and tipiracil hydrochloride (TAS-102) in treating patients with colorectal cancer that is negative for RAS wild-type colorectal cancer has spread to other places in the body (metastatic), and/or cannot be removed by surgery (unresectable), and is negative for resistance mutations in blood. Treatment with panitumumab may interfere with the ability of tumor cells to grow and spread. Some tumors need growth factors to keep growing. Growth factor antagonists, such as regorafenib, may interfere with the growth factor and stop the tumor from growing. Drugs used in chemotherapy, such as TAS-102, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving panitumumab may work better in treating patients with colorectal cancer than with the usual treatment of regorafenib or TAS-102.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer
NCT03981614
Metastatic Colorectal Carcinoma
Stage IV Colorectal Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
+3 more
COMPLETED
PHASE2
A Phase I/II Study for the Safety and Efficacy of Panitumumab in Combination With TAS-102 for Patients With Colorectal Cancer
NCT02613221
Colorectal Cancer
COMPLETED
PHASE1/PHASE2
Study of Hepatic Arterial Infusion With Intravenous Irinotecan, 5FU and Leucovorin With or Without Panitumumab, in Patients With Wild Type RAS Who Have Resected Hepatic Metastases From Colorectal Cancer
NCT01312857
Metastatic Colorectal Cancer
COMPLETED
PHASE2
Regorafenib, With Cetuximab or Panitumumab, for the Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancer
NCT04117945
BRAF V600E Negative
KRAS Gene Mutation Negative
Locally Advanced Unresectable Colorectal Adenocarcinoma
+10 more
ACTIVE_NOT_RECRUITING
PHASE2
TAS-102, Irinotecan, and Bevacizumab for the Treatment of Pre-treated Metastatic or Unresectable Colorectal Cancer, the TABAsCO Study
NCT04109924
Advanced Colorectal Carcinoma
Metastatic Colon Adenocarcinoma
Metastatic Rectal Adenocarcinoma
+24 more
COMPLETED
PHASE2
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
PRIMARY OBJECTIVE:
I. To compare the overall survival (OS) in molecularly selected patients with metastatic colorectal cancer (CRC) receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
SECONDARY OBJECTIVES:
I. To compare the progression free survival (PFS) in molecularly selected patients with metastatic CRC receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
II. To define the objective response rate (ORR) in patients receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
III. To define the clinical benefit rate (CBR = complete response + partial response + stable disease \>= 4 months) in patients receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
IV. To compare the safety and tolerability of panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
V. To compare quality of life (QOL) between panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib) as measured by the linear analogue self-assessment (LASA) questionnaires.
CORRELATIVE RESEARCH OBJECTIVES:
I. To assess plasma pharmacodynamics biomarkers of response and resistance to therapy.
II. To explore any correlation between tissue and blood based biomarkers and clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive panitumumab intravenously (IV) over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 1-5 and 8-12, or regorafenib PO once daily (QD) on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 3 years after randomization.
I. To compare the overall survival (OS) in molecularly selected patients with metastatic colorectal cancer (CRC) receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
SECONDARY OBJECTIVES:
I. To compare the progression free survival (PFS) in molecularly selected patients with metastatic CRC receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
II. To define the objective response rate (ORR) in patients receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
III. To define the clinical benefit rate (CBR = complete response + partial response + stable disease \>= 4 months) in patients receiving panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
IV. To compare the safety and tolerability of panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib).
V. To compare quality of life (QOL) between panitumumab rechallenge versus standard therapy (TAS-102 or regorafenib) as measured by the linear analogue self-assessment (LASA) questionnaires.
CORRELATIVE RESEARCH OBJECTIVES:
I. To assess plasma pharmacodynamics biomarkers of response and resistance to therapy.
II. To explore any correlation between tissue and blood based biomarkers and clinical outcomes.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM A: Patients receive panitumumab intravenously (IV) over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
ARM B: Patients receive trifluridine and tipiracil hydrochloride orally (PO) twice daily (BID) on days 1-5 and 8-12, or regorafenib PO once daily (QD) on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months for up to 3 years after randomization.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Metastatic Colon Adenocarcinoma
Metastatic Colorectal Carcinoma
Metastatic Rectal Adenocarcinoma
Stage III Colon Cancer AJCC v8
Stage III Colorectal Cancer AJCC v8
Stage III Rectal Cancer AJCC v8
Stage IIIA Colon Cancer AJCC v8
Stage IIIA Colorectal Cancer AJCC v8
Stage IIIA Rectal Cancer AJCC v8
Stage IIIB Colon Cancer AJCC v8
Stage IIIB Colorectal Cancer AJCC v8
Stage IIIB Rectal Cancer AJCC v8
Stage IIIC Colon Cancer AJCC v8
Stage IIIC Colorectal Cancer AJCC v8
Stage IIIC Rectal Cancer AJCC v8
Stage IV Colon Cancer AJCC v8
Stage IV Colorectal Cancer AJCC v8
Stage IV Rectal Cancer AJCC v8
Stage IVA Colon Cancer AJCC v8
Stage IVA Colorectal Cancer AJCC v8
Stage IVA Rectal Cancer AJCC v8
Stage IVB Colon Cancer AJCC v8
Stage IVB Colorectal Cancer AJCC v8
Stage IVB Rectal Cancer AJCC v8
Stage IVC Colon Cancer AJCC v8
Stage IVC Colorectal Cancer AJCC v8
Stage IVC Rectal Cancer AJCC v8
Unresectable Colon Adenocarcinoma
Unresectable Colorectal Carcinoma
Unresectable Rectal Adenocarcinoma
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Arm A (panitumumab)
Patients receive panitumumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
Group Type
EXPERIMENTAL
Panitumumab
Intervention Type
BIOLOGICAL
Given IV
Quality-of-Life Assessment
Intervention Type
OTHER
Ancillary studies
Questionnaire Administration
Intervention Type
OTHER
Ancillary studies
Arm B (regorafenib, trifluridine and tipiracil hydrochloride)
Patients receive trifluridine and tipiracil hydrochloride PO BID on days 1-5 and 8-12, or regorafenib PO QD on days 1-21, at the discretion of the treating physician. Treatment repeats every 28 days for a maximum of 24 cycles in the absence of disease progression or unacceptable toxicity.
Group Type
ACTIVE_COMPARATOR
Quality-of-Life Assessment
Intervention Type
OTHER
Ancillary studies
Questionnaire Administration
Intervention Type
OTHER
Ancillary studies
Regorafenib
Intervention Type
DRUG
Given PO
Trifluridine and Tipiracil Hydrochloride
Intervention Type
DRUG
Given PO
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Panitumumab
Given IV
Intervention Type
BIOLOGICAL
Quality-of-Life Assessment
Ancillary studies
Intervention Type
OTHER
Questionnaire Administration
Ancillary studies
Intervention Type
OTHER
Regorafenib
Given PO
Intervention Type
DRUG
Trifluridine and Tipiracil Hydrochloride
Given PO
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
ABX-EGF
ABX-EGF Monoclonal Antibody
ABX-EGF, Clone E7.6.3
E7.6.3
Human IgG2K Monoclonal Antibody
MoAb ABX-EGF
MoAb E7.6.3
Monoclonal Antibody ABX-EGF
Monoclonal Antibody E7.6.3
Vectibix
Quality of Life Assessment
BAY 73-4506
Regorafenib Anhydrous
Lonsurf
TAS 102
TAS-102
Tipiracil Hydrochloride Mixture with Trifluridine
Trifluridine/Tipiracil
Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Most recent Guardant360 blood collection date =\< 90 days prior to randomization.
* NOTE: If a patient does not have Guardant360 test results available, enrollment in ACCRU\_GI-1611 (COLOMATE) is strongly encouraged.
* Greater than 90 days has elapsed between the most recent treatment with an anti-epidermal growth factor receptor gene (EGFR) therapy (cetuximab or panitumumab) and blood collection for Guardant360 assay.
* Age \>= 18 years.
* Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable.
* Documented wild-type in KRAS and NRAS (codons 12, 13, 59, 61, 117, and 146) and in BRAF codon 600, based on tumor tissue taken from primary or metastatic site prior to receipt of anti EGFR therapy.
* Progression, intolerance, or contraindication to:
* A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine)
* Oxaliplatin
* Irinotecan
* An anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept).
* If the tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability (MSI)-high based on tumor tissue testing, an anti-programmed death (PD)-1 monoclonal antibody (including but not limited to nivolumab or pembrolizumab).
* Clinical or radiographic progression after treatment with an anti-EGFR monoclonal antibody (cetuximab and/or panitumumab) for at least 3 months (minimum of 6 biweekly treatments or 12 weekly treatments at full or partial dose).
* NOTE: Treatments do not need to be administered consecutively.
* NOTE: Dose reductions or delays are permitted.
* At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation.
* Life expectancy \>= 3 months per estimation of investigator.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2.
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 without colony stimulating factor support (obtained =\< 7 days prior to randomization).
* Platelet count \>= 75,000 /mm\^3 (obtained =\< 7 days prior to randomization).
* Hemoglobin \> 8.0 g/dL (obtained =\< 7 days prior to randomization).
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 7 days prior to randomization).
* Aspartate transaminase (AST) =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer) (obtained =\< 7 days prior to randomization).
* Alanine aminotransferase (ALT) =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer) (obtained =\< 7 days prior to randomization).
* Calculated creatinine clearance must be \> 30 ml/min using the Cockcroft-Gault formula or serum creatinine \< 1.5 x ULN (obtained =\< 7 days prior to randomization).
* Women of child bearing potential and male partners of women of child bearing potential must agree to use two medically accepted methods of contraception, one of them being a barrier method during the study and for 2 months after the last dose of study drug(s).
* Negative serum pregnancy test done =\< 7 days prior to randomization, for women of childbearing potential only.
* NOTE: Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopause is defined as amenorrhea \>= 12 consecutive months.
* NOTE: Women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, ovarian suppression or any other reversible treatment.
* Ability to complete questionnaire(s) by themselves or with assistance.
* Capable of understanding and complying with the protocol requirements and has signed the informed consent document.
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
* Willing to provide tissue and blood samples for correlative research purposes.
* Willing to allow transfer of tissue and blood samples, clinical information, and outcome data collected from this trial for future research.
* NOTE: If a patient does not have Guardant360 test results available, enrollment in ACCRU\_GI-1611 (COLOMATE) is strongly encouraged.
* Greater than 90 days has elapsed between the most recent treatment with an anti-epidermal growth factor receptor gene (EGFR) therapy (cetuximab or panitumumab) and blood collection for Guardant360 assay.
* Age \>= 18 years.
* Histologically and/or cytologically confirmed adenocarcinoma of the colon or rectum that is metastatic and/ or unresectable.
* Documented wild-type in KRAS and NRAS (codons 12, 13, 59, 61, 117, and 146) and in BRAF codon 600, based on tumor tissue taken from primary or metastatic site prior to receipt of anti EGFR therapy.
* Progression, intolerance, or contraindication to:
* A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine)
* Oxaliplatin
* Irinotecan
* An anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept).
* If the tumor has deficient mismatch repair proteins (dMMR) or is microsatellite instability (MSI)-high based on tumor tissue testing, an anti-programmed death (PD)-1 monoclonal antibody (including but not limited to nivolumab or pembrolizumab).
* Clinical or radiographic progression after treatment with an anti-EGFR monoclonal antibody (cetuximab and/or panitumumab) for at least 3 months (minimum of 6 biweekly treatments or 12 weekly treatments at full or partial dose).
* NOTE: Treatments do not need to be administered consecutively.
* NOTE: Dose reductions or delays are permitted.
* At least one site of disease that is measurable by Response Evaluation Criteria in Solid Tumors (RECIST) criteria that has not been previously irradiated; if the patient has had previous radiation to the target lesion(s), there must be evidence of progression since the radiation.
* Life expectancy \>= 3 months per estimation of investigator.
* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0, 1, or 2.
* Absolute neutrophil count (ANC) \>= 1500/mm\^3 without colony stimulating factor support (obtained =\< 7 days prior to randomization).
* Platelet count \>= 75,000 /mm\^3 (obtained =\< 7 days prior to randomization).
* Hemoglobin \> 8.0 g/dL (obtained =\< 7 days prior to randomization).
* Total bilirubin =\< 1.5 x upper limit of normal (ULN) (obtained =\< 7 days prior to randomization).
* Aspartate transaminase (AST) =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer) (obtained =\< 7 days prior to randomization).
* Alanine aminotransferase (ALT) =\< 2.5 x ULN (=\< 5 x ULN for subjects with liver involvement of their cancer) (obtained =\< 7 days prior to randomization).
* Calculated creatinine clearance must be \> 30 ml/min using the Cockcroft-Gault formula or serum creatinine \< 1.5 x ULN (obtained =\< 7 days prior to randomization).
* Women of child bearing potential and male partners of women of child bearing potential must agree to use two medically accepted methods of contraception, one of them being a barrier method during the study and for 2 months after the last dose of study drug(s).
* Negative serum pregnancy test done =\< 7 days prior to randomization, for women of childbearing potential only.
* NOTE: Women of childbearing potential include women who have experienced menarche and who have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are not postmenopausal. Postmenopause is defined as amenorrhea \>= 12 consecutive months.
* NOTE: Women who have been amenorrheic for 12 or more months are still considered to be of childbearing potential if the amenorrhea is possibly due to prior chemotherapy, anti-estrogens, ovarian suppression or any other reversible treatment.
* Ability to complete questionnaire(s) by themselves or with assistance.
* Capable of understanding and complying with the protocol requirements and has signed the informed consent document.
* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
* Willing to provide tissue and blood samples for correlative research purposes.
* Willing to allow transfer of tissue and blood samples, clinical information, and outcome data collected from this trial for future research.
Exclusion Criteria
* Radiation therapy, hormonal therapy, biologic therapy, experimental therapy, or chemotherapy for cancer \< 21 days prior to randomization.
* Therapeutic anticoagulation with Vitamin-K antagonists (e.g., warfarin).
* Maximum mutant allele frequency (highest allele frequency reported for any gene mutation) (MAF) less than 0.5% by Guardant360 assay.
* Detection of at least one of the following gene mutation(s) or amplification(s) by Guardant360 assay.
* BRAFV600E mutation (mutant allele frequency (MAF) \>= 0.5% or amplification.
* EGFR mutation (MAF \>= 0.5%). Note: EGFR S492R, K467, and R451C mutations are not an exclusion.
* ERBB2 (HER2) amplification.
* KRAS mutation (MAF \>= 0.5%) or amplification.
* MET amplification.
* NRAS mutation (MAF \>= 0.5%) or amplification.
* Prior treatment with both TAS-102 and regorafenib (prior treatment with either TAS-102 or regorafenib is permitted).
* Unable to swallow oral tablets (crushing of study treatment tablets is not allowed).
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Note: This includes impaired heart function or clinically significant heart disease.
* Not recovered to baseline or Common Terminology for Adverse Events (CTCAE) version (v)5.0 =\< grade 1 from toxicity due to all prior therapies except alopecia, oxaliplatin-related neuropathy, asymptomatic electrolyte abnormalities, and other non-clinically significant adverse events.
* Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
* Pregnant women.
* Nursing women.
* Men or women of childbearing potential who are unwilling to employ adequate contraception.
* Patients with known central nervous system (CNS) metastases. Note: Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive (based on repeat imaging \>= 30 days after completion of definitive treatment), patients are asymptomatic, and no steroids to control symptoms related to CNS metastases have been administered for at least 30 days.
* Major surgical procedure, open biopsy, or significant traumatic injury =\< 28 days prior to randomization (=\< 56 days for hepatectomy, open thoracotomy, major neurosurgery) or anticipation of need for major surgical procedure during the course of the study.
* Serious, non-healing wound, ulcer, or bone fracture.
* History of stroke (cerebrovascular accident), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery =\< 6 months prior to randomization.
* History of cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blockers, or digoxin =\< 6 months prior to randomization.
* Known history of congestive heart failure - New York Heart Association (NYHA) \>= class II.
* Known history of human immunodeficiency virus (HIV) seropositivity, acute or chronic active hepatitis B or C infection, or other serious chronic infection requiring ongoing treatment.
* History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan.
* Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from colorectal cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Note: Subjects surviving a cancer that was curatively treated and without evidence of disease or biochemical relapse (undetectable PSA for prostate cancer) for 3 or more years before randomization are allowed. All cancer treatments must be completed at least 3 years prior to randomization.
* Uncontrolled hypertension (systolic pressure \> 150 mm HG or diastolic pressure \> 90 mm Hg \[National Cancer Institute (NCI)-CTCAE v5.0\]) on repeated measurement despite optimal medical management.
* Evidence or history of bleeding diathesis or coagulopathy.
* Any hemorrhage or bleeding event \>= NCI CTCAE v5.0 grade 3, =\< 4 weeks prior to randomization.
* Ongoing active infection \> grade 2 NCI-CTCAE v5.0.
* Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulation given during the course of this trial.
* EXCEPTION: Cetuximab
* Any known history of malabsorption condition.
* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
* Use of any herbal remedy (e.g. St. John's wort) =\< 7 days prior to randomization.
* Use of strong CYP3A4 inducers or inhibitors =\< 7 days prior to randomization.
* Therapeutic anticoagulation with Vitamin-K antagonists (e.g., warfarin).
* Maximum mutant allele frequency (highest allele frequency reported for any gene mutation) (MAF) less than 0.5% by Guardant360 assay.
* Detection of at least one of the following gene mutation(s) or amplification(s) by Guardant360 assay.
* BRAFV600E mutation (mutant allele frequency (MAF) \>= 0.5% or amplification.
* EGFR mutation (MAF \>= 0.5%). Note: EGFR S492R, K467, and R451C mutations are not an exclusion.
* ERBB2 (HER2) amplification.
* KRAS mutation (MAF \>= 0.5%) or amplification.
* MET amplification.
* NRAS mutation (MAF \>= 0.5%) or amplification.
* Prior treatment with both TAS-102 and regorafenib (prior treatment with either TAS-102 or regorafenib is permitted).
* Unable to swallow oral tablets (crushing of study treatment tablets is not allowed).
* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens. Note: This includes impaired heart function or clinically significant heart disease.
* Not recovered to baseline or Common Terminology for Adverse Events (CTCAE) version (v)5.0 =\< grade 1 from toxicity due to all prior therapies except alopecia, oxaliplatin-related neuropathy, asymptomatic electrolyte abnormalities, and other non-clinically significant adverse events.
* Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
* Pregnant women.
* Nursing women.
* Men or women of childbearing potential who are unwilling to employ adequate contraception.
* Patients with known central nervous system (CNS) metastases. Note: Patients with radiated or resected lesions are permitted, provided the lesions are fully treated and inactive (based on repeat imaging \>= 30 days after completion of definitive treatment), patients are asymptomatic, and no steroids to control symptoms related to CNS metastases have been administered for at least 30 days.
* Major surgical procedure, open biopsy, or significant traumatic injury =\< 28 days prior to randomization (=\< 56 days for hepatectomy, open thoracotomy, major neurosurgery) or anticipation of need for major surgical procedure during the course of the study.
* Serious, non-healing wound, ulcer, or bone fracture.
* History of stroke (cerebrovascular accident), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, cardiac or other vascular stenting, angioplasty, or cardiac surgery =\< 6 months prior to randomization.
* History of cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers, calcium channel blockers, or digoxin =\< 6 months prior to randomization.
* Known history of congestive heart failure - New York Heart Association (NYHA) \>= class II.
* Known history of human immunodeficiency virus (HIV) seropositivity, acute or chronic active hepatitis B or C infection, or other serious chronic infection requiring ongoing treatment.
* History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computed tomography (CT) scan.
* Subjects with any previously untreated or concurrent cancer that is distinct in primary site or histology from colorectal cancer except cervical cancer in-situ, treated basal cell carcinoma, or superficial bladder tumor. Note: Subjects surviving a cancer that was curatively treated and without evidence of disease or biochemical relapse (undetectable PSA for prostate cancer) for 3 or more years before randomization are allowed. All cancer treatments must be completed at least 3 years prior to randomization.
* Uncontrolled hypertension (systolic pressure \> 150 mm HG or diastolic pressure \> 90 mm Hg \[National Cancer Institute (NCI)-CTCAE v5.0\]) on repeated measurement despite optimal medical management.
* Evidence or history of bleeding diathesis or coagulopathy.
* Any hemorrhage or bleeding event \>= NCI CTCAE v5.0 grade 3, =\< 4 weeks prior to randomization.
* Ongoing active infection \> grade 2 NCI-CTCAE v5.0.
* Known or suspected allergy or hypersensitivity to any of the study drugs, study drug classes, or excipients of the formulation given during the course of this trial.
* EXCEPTION: Cetuximab
* Any known history of malabsorption condition.
* Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results.
* Use of any herbal remedy (e.g. St. John's wort) =\< 7 days prior to randomization.
* Use of strong CYP3A4 inducers or inhibitors =\< 7 days prior to randomization.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Academic and Community Cancer Research United
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Responsibility Role
SPONSOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
John H Strickler
Role: PRINCIPAL_INVESTIGATOR
Academic and Community Cancer Research United
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Site Status
UC San Diego Moores Cancer Center
La Jolla, California, United States
Site Status
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
Site Status
Cedars Sinai Medical Center
Los Angeles, California, United States
Site Status
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Site Status
MedStar Washington Hospital Center
Washington D.C., District of Columbia, United States
Site Status
Mayo Clinic in Florida
Jacksonville, Florida, United States
Site Status
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, United States
Site Status
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
Site Status
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Site Status
Brigham and Women's Hospital
Boston, Massachusetts, United States
Site Status
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Site Status
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Site Status
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States
Site Status
Duke University Medical Center
Durham, North Carolina, United States
Site Status
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Site Status
M D Anderson Cancer Center
Houston, Texas, United States
Site Status
Aurora Cancer Care-Milwaukee West
Wauwatosa, Wisconsin, United States
Site Status
Countries
Review the countries where the study has at least one active or historical site.
United States
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2019-03306
Identifier Type: REGISTRY
Identifier Source: secondary_id
ACCRU-GI-1623
Identifier Type: OTHER
Identifier Source: secondary_id
ACCRU-GI-1623
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
TAS-102 and Oxaliplatin for the Treatment of Refractory Stage IV Colon Cancer
NCT04294264
ACTIVE_NOT_RECRUITING
PHASE2
Regorafenib + Panitumumab for Colorectal Cancers
NCT02199223
TERMINATED
PHASE1
Regorafenib and Pembrolizumab in Treating Participants With Advanced or Metastatic Colorectal Cancer
NCT03657641
ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
TAS-102 in Combination With Regorafenib or Fruquintinib for Third-line and Above Advanced Colorectal Cancer
NCT05993702
UNKNOWN
Early-Line Anti-EGFR Therapy to Facilitate Retreatment for Select Patients With mCRC
NCT04587128
ACTIVE_NOT_RECRUITING
PHASE2
Evaluating Panitumumab (ABX-EGF) in Patients With Metastatic Colorectal Cancer
NCT00111761
COMPLETED
PHASE2
A Randomized Phase 2 Trial of Fruquintinib and TAS-102 as Compared to Fruquintinib in Patients With Refractory Advanced/Metastatic Colorectal Cancer
NCT06992258
RECRUITING
PHASE2
A Vaccine (PolyPEPI1018 Vaccine) and TAS-102 for the Treatment of Metastatic Colorectal Cancer
NCT05130060
COMPLETED
PHASE1
A Phase 2 Randomized, Open-Label Study of RRx-001 vs Regorafenib in Subjects With Metastatic Colorectal Cancer
NCT02096354
COMPLETED
PHASE2
Fruquintinib With PD-1 Inhibitors Versus TAS-102 With Bevacizumab in Late-Line mCRC
NCT06031376
COMPLETED
Study to Evaluate Mechanisms of Acquired Resistance to Panitumumab
NCT00891930
COMPLETED
PHASE2
Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
NCT06445062
RECRUITING
PHASE1/PHASE2
FOLFOX/Bevacizumab With Onartuzumab (MetMAb) Versus Placebo as First-Line Treatment in Patients With Metastatic Colorectal Cancer
NCT01418222
COMPLETED
PHASE2
Identification and Treatment Of Micrometastatic Disease in Stage III Colon Cancer
NCT03803553
RECRUITING
PHASE3
A Phase I/II Study of Regorafenib Plus Avelumab in Solid Tumors
NCT03475953
RECRUITING
PHASE1/PHASE2
Panitumumab and Irinotecan as Third-Line Therapy in Treating Patients With Metastatic Colorectal Cancer
NCT00655499
COMPLETED
PHASE2
A Study of NBF-006 in Non-Small Cell Lung, Pancreatic, or Colorectal Cancer
NCT03819387
COMPLETED
PHASE1
Comparison of Survival Benefit of Panitumumab With Supportive Care to Best Supportive Care Alone in Patients With Metastatic Colorectal Cancer
NCT01412957
COMPLETED
PHASE3
Panitumumab With or Without Trametinib in Treating Patients With Stage IV Colorectal Cancer
NCT03087071
ACTIVE_NOT_RECRUITING
PHASE2
Exploratory Study of TG02-treatment as Monotherapy or in Combination With Pembrolizumab to Assess Safety and Immune Activation in Patients With Locally Advanced Primary and Recurrent Oncogenic RAS Exon 2 Mutant Colorectal Cancer
NCT02933944
TERMINATED
PHASE1
Niraparib and Panitumumab in Patients With Advanced or Metastatic Colorectal Cancer
NCT03983993
ACTIVE_NOT_RECRUITING
PHASE2
A Phase II Clinical Trial Comparing the Efficacy of RO7198457 Versus Watchful Waiting in Patients With ctDNA-positive, Resected Stage II (High Risk) and Stage III Colorectal Cancer
NCT04486378
RECRUITING
PHASE2
Study of First-line Single-agent Panitumumab in Frail Elderly Patients With Advanced Wild Type K-RAS Colorectal Cancer
NCT01126112
COMPLETED
PHASE2
Study of RMC-6236 in Patients With Advanced Solid Tumors Harboring Specific Mutations in RAS
NCT05379985
RECRUITING
PHASE1/PHASE2
Irinotecan and Panitumumab as 3rd Line Treatment for mCRC Without KRAS Mutations
NCT00792363
COMPLETED
PHASE2