Trial Outcomes & Findings for Palbociclib and Cetuximab in Metastatic Colorectal Cancer (NCT NCT03446157)

Last Updated: 2025-07-22

Results Overview

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.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

4 months

Results posted on

2025-07-22

Participant Flow

Participants were enrolled in the study between 03/23/2018 and 1/26/2023, at five cancer centers in the United States.

A total of thirty-three participants consented to the study, but nine of them were deemed to be ineligible and therefore were not enrolled in the study.

Participant milestones

Participant milestones
Measure	Cohort A Subjects never received EGFR therapy.	Cohort B Subjects previously received EGFR therapy.
Overall Study STARTED	13	11
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	13	11

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort A Subjects never received EGFR therapy.	Cohort B Subjects previously received EGFR therapy.
Overall Study Death	11	9
Overall Study Lost to Follow-up	0	1
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Palbociclib and Cetuximab in Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A n=13 Participants Subjects never received EGFR therapy.	Cohort B n=11 Participants Subjects previously received EGFR therapy.	Total n=24 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants	11 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Population: Subjects started the study treatment and tumor response was assessed.1 subject was not included because they withdrew before starting the treatment.

Outcome measures

Outcome measures
Measure	Cohort A n=12 Participants Subjects never received EGFR therapy.	Cohort B n=11 Participants Subjects previously received EGFR therapy.
Disease Control Rate Disease control (CR+PR+SD) achieved	5 Participants	1 Participants
Disease Control Rate Progression	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 4 months (Cycle 5)

Population: Six subjects started the study treatment and tumor response was assessed were included in the analysis. The remaining 18 subjects were not included because they withdrew or did not survive.

Outcome measures

Outcome measures
Measure	Cohort A n=5 Participants Subjects never received EGFR therapy.	Cohort B n=1 Participants Subjects previously received EGFR therapy.
Overall Response Rate Participants achieved (ORR) = CR + PR	3 Participants	0 Participants
Overall Response Rate Participants did not achieve (ORR) = CR + PR	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 20 months

Population: All subjects who started the study treatment were included.

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.

Outcome measures

Outcome measures
Measure	Cohort A n=12 Participants Subjects never received EGFR therapy.	Cohort B n=11 Participants Subjects previously received EGFR therapy.
Length of Overall Survival	13.9 months Interval 3.8 to 20.0	6.6 months Interval 1.4 to 9.6

SECONDARY outcome

Timeframe: Up to 20 months

Population: Subjects started the study treatment and one subject was not included because they withdrew before starting the treatment.

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.

Outcome measures

Outcome measures
Measure	Cohort A n=12 Participants Subjects never received EGFR therapy.	Cohort B n=11 Participants Subjects previously received EGFR therapy.
Length of Progression Free Survival	5.3 months Interval 2.7 to 8.8	1.8 months Interval 0.5 to 1.9

SECONDARY outcome

Timeframe: From day 1 of treatment until grade 3 or 4 events occurred. (Up to 20 monts)

Population: Subjects who started the study treatment Adverse Events were assessed.

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.

Outcome measures

Outcome measures
Measure	Cohort A n=12 Participants Subjects never received EGFR therapy.	Cohort B n=11 Participants Subjects previously received EGFR therapy.
Number of Participants With Grade 3 and Grade 4 Adverse Events Alkaline phosphatase increased	0 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Anemia	0 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Aspartate aminotransferase increased	0 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Fatigue	0 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Hypocalcemia	0 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Hypomagnesemia	1 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Lymphocyte count decreased	4 Participants	3 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Neutrophil count decreased	2 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Platelet count decreased	0 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Urticaria	0 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events Vomiting	0 Participants	1 Participants
Number of Participants With Grade 3 and Grade 4 Adverse Events White blood cell decreased	0 Participants	1 Participants

Adverse Events

Cohort A

Serious events: 4 serious events

Other events: 12 other events

Deaths: 11 deaths

Cohort B

Serious events: 3 serious events

Other events: 10 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Cohort A n=13 participants at risk Subjects did not receive EGFR Therapy previously f	Cohort B n=11 participants at risk Subjects received EGFR Therapy previously
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	7.7% 1/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	0.00% 0/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Abdominal distension	7.7% 1/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	0.00% 0/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Abdominal pain	7.7% 1/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	9.1% 1/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Nausea	15.4% 2/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	9.1% 1/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Small intestinal obstruction	7.7% 1/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	0.00% 0/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
Gastrointestinal disorders Vomiting	7.7% 1/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	9.1% 1/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
General disorders fatigue	0.00% 0/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	9.1% 1/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
General disorders fever	0.00% 0/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	9.1% 1/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
General disorders General disorders and administration site conditions - Other, specify	7.7% 1/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	0.00% 0/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
Investigations Blood bilirubin increased	0.00% 0/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	0.00% 0/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
Renal and urinary disorders Acute kidney injury	15.4% 2/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	9.1% 1/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
Renal and urinary disorders proteinuria	0.00% 0/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	9.1% 1/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.
General disorders Abdominal pain	7.7% 1/13 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.	0.00% 0/11 • Adverse events were monitored from the first day of study drug administration until 30 days after the completion of the last treatment (up to 20 months). Data on all-cause mortality were collected for up to 20 months. Any hospital admission was graded as a serious adverse event per protocol.

Other adverse events

Additional Information

Melahat Canter

University of North Carolina Lineberger Comprehensive Cancer Center

Phone: 919-445-4208

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place