Cancer of the ColonPhase 2NCT03446157
Palbociclib and Cetuximab in Metastatic Colorectal Cancer
A Phase 2 study testing Cetuximab and Palbociclib in people with Cancer of the Colon and Colon Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial summary
This research study is designed to provide a better understanding of study drugs cetuximab (Erbitux®) and palbociclib when used in combination to treat patients with metastatic colon cancer. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Cancer of the Colon, Colon Cancer, Colon Neoplasms
- What is being tested?
- Cetuximab and Palbociclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2018to 26 Jan 2026
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 4.1.1 Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- 4.1.2 Age ≥ 18 years at the time of consent.
- 4.1.3 ECOG Performance Status of 0-2
- 4.1.4 Histologically-confirmed metastatic CRC
- 4.1.5 Measurable disease according to RECIST v1.1 for solid tumors.
- 4.1.6 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 and tested for biomarkers
Show all 25Show fewer
- 4.1.7 Previously treated with at least two prior regimens of systemic chemotherapy for metastatic or locally advanced, unresectable disease, including fluoropyrimidines (5-fluorouracil and/or capecitabine), oxaliplatin, and irinotecan.
- A maintenance regimen of 5-fluorouracil or capecitabine, with or without bevacizumab, should not be counted as a separate line of treatment For patients who experienced disease recurrence during or within 6 months of completion of adjuvant chemotherapy with fluoropyrimidine and oxaliplatin, only one regimen of systemic chemotherapy for metastatic disease is required
- 4.1.8 Demonstrate adequate organ function as defined in the table below; all screening labs to be obtained prior to initiating study medications.
- System Laboratory Value Hematological Hemoglobin (Hgb) ≥ 9 g/dL Absolute Neutrophil Count (ANC) ≥ 1500/mm3 Platelets ≥ 100,000/mm3
- Renal Creatinine OR Calculated creatinine clearance ≤1.5 x ULN
- 60 mL/min by Cockcroft-Gault formula Hepatic* Bilirubin ≤ 1.0 × upper limit of normal (ULN) Aspartate aminotransferase (AST) ≤ 3 × ULN OR
- 5 × ULN (if liver metastases present) Alanine aminotransferase (ALT) ≤ 3 × ULN OR
- 5 × ULN (if liver metastases present)
- Note: Hematology and other lab parameters that are ≤ grade 2 BUT still meet criteria for study entry are allowed. Furthermore, changes in laboratory parameters during the study should not be considered adverse events unless they meet criteria for dose modification(s) of study medication outlined by the protocol and/or worsen from baseline during therapy.
- 4.1.9 Females of childbearing potential must have a negative serum pregnancy test within 72 hours prior to initiating study medications. NOTE: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided.
- 4.1.10 Females of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets <1% failure rate for protection from pregnancy in the product label.
- 4.1.11 Male patients with female partners must have had a prior vasectomy or agree to use an adequate method of contraception (i.e., double barrier method: condom plus spermicidal agent) starting with the first dose of study therapy through 6 months after the last dose of study therapy.
- 4.1.12 Subjects is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee.
- 4.1.13 Able to swallow capsules, with no surgical or anatomic condition that will preclude the patient from swallowing and absorbing oral medications.
- 4.1.14 Has not undergone any major surgical procedures for at least 4 weeks, with full healing of all surgical wounds
- 4.1.15 At sites in the Southeastern U.S., subject must have negative serum test for galactose-alpha-1,3-galactose IgE See Appendix 12.5 for map (Note: positive test result is predictive of immediate-onset anaphylaxis reaction during first exposure to cetuximab, which is prevalent predominantly in limited geographic region of the Southeastern U.S. (Clin Mol Allergy 2012;10:1-11).
- 4.1.16 For Study Cohort A, has not had prior treatment with cetuximab, panitumumab, or other anti-EGFR therapy.
- 4.1.17 For Study Cohort B, must have had previous treatment with cetuximab or panitumumab with disease control (defined as complete response, partial response, or stable disease) lasting for ≥ 4 months in duration and completed their last anti-EGFR therapy 8 weeks prior to initiating treatment.
- -
Who cannot join
- 4.2.1 Active infection requiring systemic therapy.
- 4.2.2 Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- 4.2.3 Presence of known, active central nervous system (CNS) metastases.
- 4.2.4 Treatment with any investigational drug within 28 days prior to initiating study medications.
- 4.2.5 Prior treatment with drug targeting cyclin-dependent kinase (CDK) family.
- 4.2.6 Subject is receiving prohibited medications or treatments as listed in section 5.5 of the protocol that cannot be discontinued/replaced by an alternative therapy.
Show all 21Show fewer
- 4.2.7 Known hypersensitivity to the components of study drugs or analogs of study drugs.
- 4.2.8 Has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.
- 4.2.9 Uncontrolled, severe concomitant comorbidity (e.g. uncontrolled hypertension, uncontrolled diabetes mellitus, clinically significant pulmonary disease, clinically significant neurological disorder, active or uncontrolled infection).
- 4.2.10 History of interstitial lung disease or pneumonitis.
- 4.2.11 Any other clinically significant heart disease, including angina pectoris, resting bradycardia, left bundle branch block, ventricular tachyarrhythmia, unstable atrial fibrillation, acute myocardial infarction, or heart disease requiring cardiac pacemaker or implantable cardioverter/defibrillator
- 4.2.12 Known psychiatric or substance abuse disorder that would interfere with the ability of the patient to comply with trial requirements.
- 4.2.13 History of long-QT syndrome.
- 4.2.14 Baseline QTcF ≥ 470 msec.
- 4.2.15 Concomitant use of drugs known to cause QT prolongation as defined in Appendix 12.4 and in section 5.5 (Note: Ondansetron at doses ≤ 16 mg or less is allowed)
- 4.2.16 History of any of the following cardiovascular conditions within the past 6 months:
- Class III or IV congestive heart failure as defined by the New York Heart Association Criteria
- Cardiac angioplasty or stenting
- Myocardial infarction
- Unstable angina
- Symptomatic peripheral vascular disease or other clinically significant cardiac disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, 27599-7295
About this study
Official title: Phase II Single-arm Study of the Combination of Palbociclib and Cetuximab in KRAS/NRAS/BRAF Wild-type Metastatic Colorectal Cancer
This research study is designed to provide a better understanding of study drugs cetuximab (Erbitux®) and palbociclib when used in combination to treat patients with metastatic colon cancer.
Read the detailed description
This research study is designed to provide a better understanding of study drugs cetuximab (Erbitux®) and palbociclib when used in combination to treat patients with metastatic colon cancer.
Cetuximab (Erbitux®) is an antibody designed to target a protein called Epidermal Growth Factor Receptor (EGFR). EGFR plays an important role in the growth and survival of colon cancer. Antibodies are proteins that are naturally produced by the immune system and circulate throughout your body to help protect you from disease caused by bacteria, viruses, cancer cells or any foreign or toxic substance. Antibodies work by sticking to and flagging or marking foreign cells or substances so that your body's immune defense system will recognize, attack and remove them. Antibodies help the body rid itself of disease. Antibodies can also be designed in the laboratory to stick to specific parts of cancer cells (or normal cells) to change or block the ways those cells function in your body and to produce a therapeutic anti-cancer effect. Cetuximab (Erbitux®) is an antibody drug approved by the FDA and is commonly used to treat your type of colon cancer.
Palbociclib is an FDA-approved drug for patients with breast cancer. Palbociclib is not FDA-approved for the treatment of colon cancer, and is considered an investigational drug in this research study. Palbociclib targets a protein called CDK4/6 that is a critical part of the cell division and cell growth processes known as "the cell cycle". Laboratory studies have shown that palbociclib inhibits the cell cycle, slows or stops cell growth, and can cause cell death in cancer cells.
The combination of Cetuximab (Erbitux®) with palbociclib is not approved by the FDA for treating colon cancer and is considered investigational in this research study.
You are being asked to be in the study because your colon cancer has been found to contain the proteins KRAS, NRAS and BRAF that are normal (wild-type). These proteins play an important role in the growth and survival of colon cancer. This requirement is important because colon cancer with these characteristics has been shown to be more responsive to EGFR inhibitors such as cetuximab (Erbitux®), one of the drugs used in this study that is also a standard treatment option for your type of cancer. Also, Epidermal Growth Factor Receptor (EGFR) has been shown to stimulate cancer cell division, growth and survival by working together with KRAS, NRAS and BRAF to activate CDK4/6 and to support an accelerated cell cycle. This accelerated cell cycle allows the cancer cells to divide and grow faster than your normal cells but also can make them sensitive to the effects of CDK4/6 inhibitor palbociclib, a cell-cycle inhibitor.
To participate in this study you also must meet one of the following requirements:
- You have not been treated with EGFR inhibitors such as cetuximab (Erbitux®) or panitumumab (Vectibix®).
- You were treated with anti-EGFR drugs such as cetuximab (Erbitux®) or panitumumab (Vectibix®) and experienced at least 4 months of response to treatment, and it has been at least 8-weeks since you were last treated with an anti-EGFR drug.
This will allow investigators to compare the anti-cancer effects of cetuximab (Erbitux®) combined with palbociclib in 2 different groups of cancer patients:
- Patients that have never received EGFR inhibitors like cetuximab (Erbitux®) or panitumumab (Vectibix®). This group will test whether resistance to the combination of cetuximab (Erbitux®) plus palbociclib develops in this type of cancer.
- Patients that have previously shown an anti-cancer response to EGFR inhibitors, such as cetuximab (Erbitux®) or panitumumab (Vectibix®), of four or more months, but then developed resistance. This group will test whether the combination of cetuximab (Erbitux®) plus palbociclib is more effective against this resistant type of cancer.
Furthermore, laboratory studies have shown that the combination of EGFR and CDK inhibitors provide a stronger anti-cancer effect when used in combination than seen when each inhibitor is used alone. Thus, the reason researchers are using cetuximab (Erbitux®) and palbociclib in combination is to simultaneously target and inhibit multiple processes inside of the cancer cell that are critical to growth and survival of the tumor. With this combination strategy, researchers hope to improve upon existing anti-cancer therapies.
- Being tested
- Cetuximab, Palbociclib
- Keywords
- colon cancer, metastatic colon cancer, palbociclib, cetuximab
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Also called Erbitux
Loading dose on day 1 of week 1 of 400 mg/m2 via IV over 2 hours Subsequent doses of 250 mg/m2 via IV over 1 hour weekly for 4 weeks (28 days) in combination with palbociclib
PalbociclibDrug
Also called Ibrance
125 mg taken orally once daily on days 1-21, then 7 days off
| Study group | Role | What they receive |
|---|---|---|
| Open-label, single arm, Phase II | Experimental | Cetuximab and palbociclib Receives: Drug: Cetuximab; Drug: Palbociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Control Rate
Overall Response Rate (ORR) = CR + PR Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed assessed by Positron Emission Tomography (PET)- Computerized tomography (CT) scans. If the subject experienced a Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion new lesion.
Measured: 4 months
Secondary outcomes (4)
Overall Response Rate
Overall Response Rate (ORR) = CR + PR Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed assessed by Positron Emission Tomography (PET)- Computerized tomography (CT) scans. If the subject experienced a Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion new lesion.
Measured: 4 months (Cycle 5)
Length of Overall Survival
Time from the first day of treatment until death from any cause. All subjects who started the study treatment died or withdrew at 20 months.
Measured: Up to 20 months
Length of Progression Free Survival
Time from the first day of treatment until disease progression as defined by RECIST or death from any cause.
RECIST: Radiographic response will be measured by RECIST, Response Evaluation Criteria In Solid Tumors Criteria, indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
All subjects who started the study treatment died or withdrew at 20 months.
Measured: Up to 20 months
Number of Participants With Grade 3 and Grade 4 Adverse Events
The number of participants who experienced treatment-related grade 3 and 4 toxicities defined by the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI CTCAE v4.03) criteria.
NCI CTCAE can be utilized for Adverse Event (AE) reporting. A grading (severity) scale is provided for each AE term. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
All subjects who started the study treatment died or withdrew at 20 months.
Measured: From day 1 of treatment until grade 3 or 4 events occurred. (Up to 20 monts)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2018
- Study start23 Mar 2018
- Primary completion29 May 2023
- Study completion26 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cancer of the ColonStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a multicenter, single-arm, phase II clinical trial of combination therapy with cetuximab and palbociclib in refractory KRAS, NRAS, and BRAF wild-type metastatic colorectal cancer (CRC) patients
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanna Sanoff, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03446157
- Sponsor's protocol ID
- LCCC1717
- Status last verified
- Feb 2026
- First submitted
- 20 Feb 2018
- Last updated
- 10 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Sorah JD, Moore DT, Reilley MJ, Salem ME, Triglianos T, McRee AJ, Lee MS, Sanoff HK, Somasundaram AS. Phase II single-arm study of palbociclib and cetuximab in anti-EGFR naive patients with KRAS/NRAS/BRAF wild-type, metastatic colorectal cancer. Oncologist. 2025 Oct 1;30(10):oyaf305. doi: 10.1093/oncolo/oyaf305.
PubMed 40990835Sorah JD, Moore DT, Reilley MJ, Salem ME, Triglianos T, Sanoff HK, McRee AJ, Lee MS. Phase II Single-Arm Study of Palbociclib and Cetuximab Rechallenge in Patients with KRAS/NRAS/BRAF Wild-Type Colorectal Cancer. Oncologist. 2022 Dec 9;27(12):1006-e930. doi: 10.1093/oncolo/oyac222.
PubMed 36288238Noh JY, Lee IP, Han NR, Kim M, Min YK, Lee SY, Yun SH, Kim SI, Park T, Chung H, Park D, Lee CH. Additive Effect of CD73 Inhibitor in Colorectal Cancer Treatment With CDK4/6 Inhibitor Through Regulation of PD-L1. Cell Mol Gastroenterol Hepatol. 2022;14(4):769-788. doi: 10.1016/j.jcmgh.2022.07.005. Epub 2022 Jul 15.
PubMed 35843546
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Single-arm Study of the Combination of Palbociclib and Cetuximab in KRAS/NRAS/BRAF Wild-type Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03446157
- Acronym / sponsor ID
- LCCC1717
- Keywords
- colon cancer, metastatic colon cancer, palbociclib, cetuximab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Amgen, Pfizer
- Study start
- 23 Mar 2018 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 26 Jan 2026 (actual)
- First posted
- 26 Feb 2018 (actual)
- Results
- Posted 7 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is designed to provide a better understanding of study drugs cetuximab (Erbitux®) and palbociclib when used in combination to treat patients with metastatic colon cancer.
Detailed description
This research study is designed to provide a better understanding of study drugs cetuximab (Erbitux®) and palbociclib when used in combination to treat patients with metastatic colon cancer.
Cetuximab (Erbitux®) is an antibody designed to target a protein called Epidermal Growth Factor Receptor (EGFR). EGFR plays an important role in the growth and survival of colon cancer. Antibodies are proteins that are naturally produced by the immune system and circulate throughout your body to help protect you from disease caused by bacteria, viruses, cancer cells or any foreign or toxic substance. Antibodies work by sticking to and flagging or marking foreign cells or substances so that your body's immune defense system will recognize, attack and remove them. Antibodies help the body rid itself of disease. Antibodies can also be designed in the laboratory to stick to specific parts of cancer cells (or normal cells) to change or block the ways those cells function in your body and to produce a therapeutic anti-cancer effect. Cetuximab (Erbitux®) is an antibody drug approved by the FDA and is commonly used to treat your type of colon cancer.
Palbociclib is an FDA-approved drug for patients with breast cancer. Palbociclib is not FDA-approved for the treatment of colon cancer, and is considered an investigational drug in this research study. Palbociclib targets a protein called CDK4/6 that is a critical part of the cell division and cell growth processes known as "the cell cycle". Laboratory studies have shown that palbociclib inhibits the cell cycle, slows or stops cell growth, and can cause cell death in cancer cells.
The combination of Cetuximab (Erbitux®) with palbociclib is not approved by the FDA for treating colon cancer and is considered investigational in this research study.
You are being asked to be in the study because your colon cancer has been found to contain the proteins KRAS, NRAS and BRAF that are normal (wild-type). These proteins play an important role in the growth and survival of colon cancer. This requirement is important because colon cancer with these characteristics has been shown to be more responsive to EGFR inhibitors such as cetuximab (Erbitux®), one of the drugs used in this study that is also a standard treatment option for your type of cancer. Also, Epidermal Growth Factor Receptor (EGFR) has been shown to stimulate cancer cell division, growth and survival by working together with KRAS, NRAS and BRAF to activate CDK4/6 and to support an accelerated cell cycle. This accelerated cell cycle allows the cancer cells to divide and grow faster than your normal cells but also can make them sensitive to the effects of CDK4/6 inhibitor palbociclib, a cell-cycle inhibitor.
To participate in this study you also must meet one of the following requirements:
- You have not been treated with EGFR inhibitors such as cetuximab (Erbitux®) or panitumumab (Vectibix®).
- You were treated with anti-EGFR drugs such as cetuximab (Erbitux®) or panitumumab (Vectibix®) and experienced at least 4 months of response to treatment, and it has been at least 8-weeks since you were last treated with an anti-EGFR drug.
This will allow investigators to compare the anti-cancer effects of cetuximab (Erbitux®) combined with palbociclib in 2 different groups of cancer patients:
- Patients that have never received EGFR inhibitors like cetuximab (Erbitux®) or panitumumab (Vectibix®). This group will test whether resistance to the combination of cetuximab (Erbitux®) plus palbociclib develops in this type of cancer.
- Patients that have previously shown an anti-cancer response to EGFR inhibitors, such as cetuximab (Erbitux®) or panitumumab (Vectibix®), of four or more months, but then developed resistance. This group will test whether the combination of cetuximab (Erbitux®) plus palbociclib is more effective against this resistant type of cancer.
Furthermore, laboratory studies have shown that the combination of EGFR and CDK inhibitors provide a stronger anti-cancer effect when used in combination than seen when each inhibitor is used alone. Thus, the reason researchers are using cetuximab (Erbitux®) and palbociclib in combination is to simultaneously target and inhibit multiple processes inside of the cancer cell that are critical to growth and survival of the tumor. With this combination strategy, researchers hope to improve upon existing anti-cancer therapies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a multicenter, single-arm, phase II clinical trial of combination therapy with cetuximab and palbociclib in refractory KRAS, NRAS, and BRAF wild-type metastatic colorectal cancer (CRC) patients
| Arm | Type | Receives |
|---|---|---|
| Open-label, single arm, Phase II | Experimental | Drug: Cetuximab, Drug: PalbociclibCetuximab and palbociclib |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- 4.1.1 Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
- 4.1.2 Age ≥ 18 years at the time of consent.
- 4.1.3 ECOG Performance Status of 0-2
- 4.1.4 Histologically-confirmed metastatic CRC
- 4.1.5 Measurable disease according to RECIST v1.1 for solid tumors.
Key exclusion criteria (21 listed)
- 4.2.1 Active infection requiring systemic therapy.
- 4.2.2 Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).
- 4.2.3 Presence of known, active central nervous system (CNS) metastases.
- 4.2.4 Treatment with any investigational drug within 28 days prior to initiating study medications.
- 4.2.5 Prior treatment with drug targeting cyclin-dependent kinase (CDK) family.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabAlso: ErbituxLoading dose on day 1 of week 1 of 400 mg/m2 via IV over 2 hours Subsequent doses of 250 mg/m2 via IV over 1 hour weekly for 4 weeks (28 days) in combination with palbociclib | Drug | Open-label, single arm, Phase II |
| PalbociclibAlso: Ibrance125 mg taken orally once daily on days 1-21, then 7 days off | Drug | Open-label, single arm, Phase II |
Primary outcome
Disease Control Rate
Time frame: 4 months
Overall Response Rate (ORR) = CR + PR Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed assessed by Positron Emission Tomography (PET)- Computerized tomography (CT) scans. If the subject experienced a Complete Response (CR), the disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion new lesion.
4 secondary outcomes
Overall Response Rate
Time frame: 4 months (Cycle 5)
Length of Overall Survival
Time frame: Up to 20 months
Length of Progression Free Survival
Time frame: Up to 20 months
Number of Participants With Grade 3 and Grade 4 Adverse Events
Time frame: From day 1 of treatment until grade 3 or 4 events occurred. (Up to 20 monts)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40990835Sorah JD, Moore DT, Reilley MJ, Salem ME, Triglianos T, McRee AJ, Lee MS, Sanoff HK, Somasundaram AS. Phase II single-arm study of palbociclib and cetuximab in anti-EGFR naive patients with KRAS/NRAS/BRAF wild-type, metastatic colorectal cancer. Oncologist. 2025 Oct 1;30(10):oyaf305. doi: 10.1093/oncolo/oyaf305.
- Derived from this study: PubMed 36288238Sorah JD, Moore DT, Reilley MJ, Salem ME, Triglianos T, Sanoff HK, McRee AJ, Lee MS. Phase II Single-Arm Study of Palbociclib and Cetuximab Rechallenge in Patients with KRAS/NRAS/BRAF Wild-Type Colorectal Cancer. Oncologist. 2022 Dec 9;27(12):1006-e930. doi: 10.1093/oncolo/oyac222.
- Derived from this study: PubMed 35843546Noh JY, Lee IP, Han NR, Kim M, Min YK, Lee SY, Yun SH, Kim SI, Park T, Chung H, Park D, Lee CH. Additive Effect of CD73 Inhibitor in Colorectal Cancer Treatment With CDK4/6 Inhibitor Through Regulation of PD-L1. Cell Mol Gastroenterol Hepatol. 2022;14(4):769-788. doi: 10.1016/j.jcmgh.2022.07.005. Epub 2022 Jul 15.
- UNC LinebergerLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanna Sanoff principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cetuximab and Palbociclib in people with Cancer of the Colon and Colon Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease Control Rate (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03446157, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.