Trial Outcomes & Findings for Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer (NCT NCT04853043)

Last Updated: 2025-05-06

Results Overview

Evaluate the PFS among patients treated with cetuximab in APC, TP53 and RAS mutated refractory metastatic colorectal cancer. PFS will be measured from the date of first dose of study drug until the first documented radiographic evidence of disease progression by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) criteria 1.1, clinical progression per investigator judgement, start of new anti-cancer therapy, or death from any cause. Per RECIST 1.1 for target lesions, Progressive Disease (PD) is a \>=20% increase in the sum of the longest diameter (LD) of target lesions. Disease progression by RECIST 1.1 is PD.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

7 participants

Primary outcome timeframe

PFS will be measured from the date of first dose of study drug until first documented clinical or radiographic evidence of disease progression by RECIST 1.1, clinical progression, start of new therapy or death. Estimated assessment at 6 months.

Results posted on

2025-05-06

Participant Flow

Participant milestones

Participant milestones
Measure	Cetuximab Cetuximab: Cetuximab will be administered every 2 weeks (14 days). The initial dose of 500 mg/m2 is to be administered by IV infusion over 120 minutes on the first day of the treatment. In the absence of infusion reactions, subsequent doses are to be administered over 60 minutes biweekly. Each cycle will be defined as 14 days of treatment.
Overall Study STARTED	7
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cetuximab in Third Line for Mutant APC, TP53 and RAS Patients With Refractory Metastatic Colorectal Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cetuximab n=7 Participants Cetuximab: Cetuximab will be administered every 2 weeks (14 days). The initial dose of 500 mg/m2 is to be administered by IV infusion over 120 minutes on the first day of the treatment. In the absence of infusion reactions, subsequent doses are to be administered over 60 minutes biweekly. Each cycle will be defined as 14 days of treatment.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	54.71 years STANDARD_DEVIATION 8.42 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) 0 Fully active	0 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) 1 Restricted	7 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) 2 Ambulatory	0 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) 3 Limited selfcare	0 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) 4 Completely disabled	0 Participants n=5 Participants
Eastern Cooperative Oncology Group (ECOG) 5 Dead	0 Participants n=5 Participants
Height	167.13 cm STANDARD_DEVIATION 10.17 • n=5 Participants
Weight	88.34 kg STANDARD_DEVIATION 33.94 • n=5 Participants
Body Mass Index (BMI)	31.02 kg/m^2 STANDARD_DEVIATION 10.25 • n=5 Participants

PRIMARY outcome

Timeframe: PFS will be measured from the date of first dose of study drug until first documented clinical or radiographic evidence of disease progression by RECIST 1.1, clinical progression, start of new therapy or death. Estimated assessment at 6 months.

Outcome measures

Outcome measures
Measure	Cetuximab n=7 Participants Cetuximab: Cetuximab will be administered every 2 weeks (14 days). The initial dose of 500 mg/m2 is to be administered by IV infusion over 120 minutes on the first day of the treatment. In the absence of infusion reactions, subsequent doses are to be administered over 60 minutes biweekly. Each cycle will be defined as 14 days of treatment.
Progression Free Survival (PFS)	48 days Interval 27.68 to 54.04

SECONDARY outcome

Timeframe: OS was measured from the date of first dose of study drug until death from any cause (up to 223 days)

Evaluate the overall survival (OS) among patients treated with cetuximab in APC, TP53 and RAS mutated refractory metastatic colorectal cancer. Upon discontinuation of study therapy, subjects will be followed for survival from the date of study therapy initiation until death, end of the study, or subject withdrawal of consent, whichever comes first.

Outcome measures

Outcome measures
Measure	Cetuximab n=7 Participants Cetuximab: Cetuximab will be administered every 2 weeks (14 days). The initial dose of 500 mg/m2 is to be administered by IV infusion over 120 minutes on the first day of the treatment. In the absence of infusion reactions, subsequent doses are to be administered over 60 minutes biweekly. Each cycle will be defined as 14 days of treatment.
Overall Survival (OS).	94.50 days Interval 54.74 to 158.26

Adverse Events

Cetuximab

Serious events: 3 serious events

Other events: 7 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Cetuximab n=7 participants at risk Cetuximab: Cetuximab will be administered every 2 weeks (14 days). The initial dose of 500 mg/m2 is to be administered by IV infusion over 120 minutes on the first day of the treatment. In the absence of infusion reactions, subsequent doses are to be administered over 60 minutes biweekly. Each cycle will be defined as 14 days of treatment.
Gastrointestinal disorders Abdominal distension	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Abdominal pain	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Alkaline phosphatase increased	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Colonic obstruction	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Electrocardiogram QT corrected interval prolonged	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hypokalemia	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Small intestinal obstruction	42.9% 3/7 • Number of events 4 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).

Other adverse events

Other adverse events
Measure	Cetuximab n=7 participants at risk Cetuximab: Cetuximab will be administered every 2 weeks (14 days). The initial dose of 500 mg/m2 is to be administered by IV infusion over 120 minutes on the first day of the treatment. In the absence of infusion reactions, subsequent doses are to be administered over 60 minutes biweekly. Each cycle will be defined as 14 days of treatment.
Gastrointestinal disorders Abdominal pain	42.9% 3/7 • Number of events 3 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Alanine aminotransferase increased	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Alkaline phosphatase increased	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Anemia	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Anorexia	42.9% 3/7 • Number of events 5 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Ascites	42.9% 3/7 • Number of events 3 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Aspartate aminotransferase increased	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Back pain	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Blood and lymphatic system disorders - Other, specify	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Blood bicarbonate decreased	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Blood bilirubin increased	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Bullous dermatitis	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Constipation	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Creatinine increased	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Dehydration	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Diarrhea	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Disease progression	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Edema limbs	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Encephalopathy	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Fatigue	42.9% 3/7 • Number of events 3 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Gastrointestinal disorders Fever	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Headache	71.4% 5/7 • Number of events 5 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hematuria	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hepatobiliary disorders - Other, specify	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hot flashes	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hypercalcemia	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hyperglycemia	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hyperkalemia	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hypoalbuminemia	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hypocalcemia	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hypokalemia	14.3% 1/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Hyponatremia	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Infusion related reaction	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Insomnia	42.9% 3/7 • Number of events 4 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Leukocytosis	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Lipase increased	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Lymphocyte count decreased	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Metabolism and nutrition disorders - Other, specify	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Nail changes	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Nausea	28.6% 2/7 • Number of events 3 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Nervous system disorders - Other, specify	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Pain	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Pain in extremity	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Nervous system disorders Proteinuria	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Skin and subcutaneous tissue disorders Rash acneiform	57.1% 4/7 • Number of events 6 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Rash maculo-papular	28.6% 2/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Respiratory, thoracic and mediastinal disorders - Other, specify	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Sepsis	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Cardiac disorders Sinus bradycardia	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Cardiac disorders Sinus tachycardia	14.3% 1/7 • Number of events 2 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Skin and subcutaneous tissue disorders - Other, specify	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Small intestinal obstruction	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Surgical and medical procedures - Other, specify	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Vaginal hemorrhage	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Vomiting	42.9% 3/7 • Number of events 3 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).
Metabolism and nutrition disorders Weight loss	14.3% 1/7 • Number of events 1 • Adverse events were followed until 30 days (± 7 days) after the last dose of study drug (up to 112 days after initiation of study treatment). Survival was followed from the date of the first dose of study drug until death from any cause (up to 223 days after initiation of study treatment).

Additional Information

IIT Data Management Team

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Results disclosure agreements

Principal investigator is a sponsor employee Each party shall have the right to publish and disseminate information derived from the performance of the Statement of Work. Qualification for authorship shall be in keeping with generally accepted criteria. Intermountain Health Services shall provide the University of Utah with a copy of any proposed publication for review and comment at least thirty (30) days prior to submission.
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