Trial Outcomes & Findings for Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma (NCT NCT06046482)

NCT ID: NCT06046482

Last Updated: 2025-10-22

Results Overview

Objective Response Rate (ORR) per RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI: 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), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter with an absolute increase of at least 5 mm or the appearance of new lesions

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 4 participants
• Primary outcome timeframe: 140 days
• Results posted on: 2025-10-22

Participant Flow

Participant milestones

Measure	Cohort A Anti-PD1 naïve, treatment with Magrolimab, Cetuximab, and Pembrolizumab and Cohort A Maintenance Anti-PD1 naïve, magro IV QW/cetux IV QW/pembro IV Q3W	Cohort B Anti-PD1 refractory, treatment with Magrolimab, Cetuximab and Docetaxel Anti-PD1 refractory magro IV QW/cetux IV QW/docetaxel IV QW
Overall Study STARTED	1	3
Overall Study COMPLETED	1	3
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma

Baseline characteristics by cohort

Measure	Cohort A n=1 Participants Anti-PD1 naïve, treatment with Magrolimab, Cetuximab, and Pembrolizumab and Cohort A Maintenance Anti-PD1 naïve, magro IV QW/cetux IV QW/pembro IV Q3W	Cohort B n=3 Participants Anti-PD1 refractory, treatment with Magrolimab, Cetuximab and Docetaxel Anti-PD1 refractory magro IV QW/cetux IV QW/docetaxel IV QW	Total n=4 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	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	4 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	3 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 140 days

Objective Response Rate (ORR) per RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI: 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), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), >= 20% increase in the sum of the longest diameter with an absolute increase of at least 5 mm or the appearance of new lesions

Outcome measures

Measure	Cohort A n=1 Participants Anti-PD1 naïve, treatment with Magrolimab, Cetuximab, and Pembrolizumab and Cohort A Maintenance Anti-PD1 naïve, magro IV QW/cetux IV QW/pembro IV Q3W	Cohort B n=3 Participants Anti-PD1 refractory, treatment with Magrolimab, Cetuximab and Docetaxel Anti-PD1 refractory magro IV QW/cetux IV QW/docetaxel IV QW
Objective Response Rate (ORR) Partial Response (PR)	1 Participants	0 Participants
Objective Response Rate (ORR) Stable Disease (SD)	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 145 days

Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 5.0 guidelines. All AEs, whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy

Outcome measures

Measure	Cohort A n=1 Participants Anti-PD1 naïve, treatment with Magrolimab, Cetuximab, and Pembrolizumab and Cohort A Maintenance Anti-PD1 naïve, magro IV QW/cetux IV QW/pembro IV Q3W	Cohort B n=3 Participants Anti-PD1 refractory, treatment with Magrolimab, Cetuximab and Docetaxel Anti-PD1 refractory magro IV QW/cetux IV QW/docetaxel IV QW
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 3 : Definite	0 Treatment-Emergent Adverse Events TEAEs	1 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 3 : Possible	0 Treatment-Emergent Adverse Events TEAEs	2 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 3 : Probable	0 Treatment-Emergent Adverse Events TEAEs	0 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 3 : Unlikely	0 Treatment-Emergent Adverse Events TEAEs	0 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 3 : Unrelated	1 Treatment-Emergent Adverse Events TEAEs	0 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 2 : Definite	1 Treatment-Emergent Adverse Events TEAEs	2 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 2 : Possible	3 Treatment-Emergent Adverse Events TEAEs	2 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 2 : Probable	0 Treatment-Emergent Adverse Events TEAEs	3 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 2 : Unlikely	0 Treatment-Emergent Adverse Events TEAEs	0 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 2 : Unrelated	3 Treatment-Emergent Adverse Events TEAEs	1 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 1 : Definite	1 Treatment-Emergent Adverse Events TEAEs	8 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 1 : Possible	8 Treatment-Emergent Adverse Events TEAEs	17 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 1 : Probable	2 Treatment-Emergent Adverse Events TEAEs	5 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 1 : Unlikely	3 Treatment-Emergent Adverse Events TEAEs	10 Treatment-Emergent Adverse Events TEAEs
Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 Grade 1 : Unrelated	9 Treatment-Emergent Adverse Events TEAEs	5 Treatment-Emergent Adverse Events TEAEs

SECONDARY outcome

Timeframe: 2 weeks and 1 day

Population: Cohort A - participant withdrew consent after 15 days. Cohort B -- no patients in cohort B achieved a PR.

Time (the duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 months and 4 days

Progression free survival (PFS) per RECIST v1.1. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the longest diamester of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions

Outcome measures

Measure	Cohort A n=1 Participants Anti-PD1 naïve, treatment with Magrolimab, Cetuximab, and Pembrolizumab and Cohort A Maintenance Anti-PD1 naïve, magro IV QW/cetux IV QW/pembro IV Q3W	Cohort B n=3 Participants Anti-PD1 refractory, treatment with Magrolimab, Cetuximab and Docetaxel Anti-PD1 refractory magro IV QW/cetux IV QW/docetaxel IV QW
Number of Participants With Progression Free Survival (PFS) and/or Death Disease progression	0 Participants	1 Participants
Number of Participants With Progression Free Survival (PFS) and/or Death Death on study	0 Participants	0 Participants

Adverse Events

Cohort A

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort B

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A n=1 participants at risk Anti-PD1 naïve, treatment with Magrolimab, Cetuximab, and Pembrolizumab and Cohort A Maintenance Anti-PD1 naïve, magro IV QW/cetux IV QW/pembro IV Q3W	Cohort B n=3 participants at risk Anti-PD1 refractory, treatment with Magrolimab, Cetuximab and Docetaxel Anti-PD1 refractory magro IV QW/cetux IV QW/docetaxel IV QW
Gastrointestinal disorders Colitis	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days

Other adverse events

Measure	Cohort A n=1 participants at risk Anti-PD1 naïve, treatment with Magrolimab, Cetuximab, and Pembrolizumab and Cohort A Maintenance Anti-PD1 naïve, magro IV QW/cetux IV QW/pembro IV Q3W	Cohort B n=3 participants at risk Anti-PD1 refractory, treatment with Magrolimab, Cetuximab and Docetaxel Anti-PD1 refractory magro IV QW/cetux IV QW/docetaxel IV QW
Gastrointestinal disorders Abdominal Pain	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	66.7% 2/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Alanine aminotransferase increased	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Alkaline phosphatase increased	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Blood and lymphatic system disorders Anemia	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	100.0% 3/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Aspartate aminotransferase increased	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Musculoskeletal and connective tissue disorders Back pain	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Blood bilirubin increased	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Blood lactate dehydrogenase increased	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Infections and infestations Conjunctivitis	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Gastrointestinal disorders Constipation	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Creatinine Increased	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Gastrointestinal disorders Diarrhea	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Nervous system disorders Dizziness	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Gastrointestinal disorders Dry Mouth	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Gastrointestinal disorders Dysphagia	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Eye disorders Eye Pain	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
General disorders Fatigue	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	66.7% 2/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Vascular disorders Flushing	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	66.7% 2/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Metabolism and nutrition disorders Hyperkalemia	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Metabolism and nutrition disorders Hypomagenesemia	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Metabolism and nutrition disorders Hyponatremia	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	66.7% 2/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
General disorders Insomnia	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Investigations, other specify	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	66.7% 2/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Gastrointestinal disorders Mucositis oral	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	100.0% 3/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Gastrointestinal disorders Nausea	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	66.7% 2/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Neutrophil count decreased	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Nervous system disorders Paresthesia	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Nervous system disorders Peripheral Motor Neuropathy	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Platelet Count Decreased	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Skin and subcutaneous tissue disorders Rash Acneiform	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	100.0% 3/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
General disorders Restlessness	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Nervous system disorders Syncope	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Infections and infestations Upper Respiratory Infection	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Renal and urinary disorders Urine discoloration	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	0.00% 0/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations Weight loss	0.00% 0/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	33.3% 1/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days
Investigations White blood cell decreased	100.0% 1/1 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days	66.7% 2/3 • From the time the first patient signed consent until the last patient has completed the observation period as designated by the protocol (pg. 45: All Aes whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy): 145 days

Additional Information

Renata Ferrarotto, MD

The University of Texas MD Anderson Cancer Center

Phone: (713) 745-6774

Email: rferrarotto@mdanderson.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place