Trial Outcomes & Findings for Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149 (NCT NCT03997448)

Last Updated: 2024-02-20

Results Overview

Progression free survival is defined as the time of treatment initiation until the criteria for disease progression per RECIST1.1 are met or until the date of a death event (any cause). Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. (Note: the appearance of one or more new lesions is also considered progressions).

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

3 participants

Primary outcome timeframe

From C1D1 until death or up to a maximum of 5 months

Results posted on

2024-02-20

Participant Flow

Participant milestones

Participant milestones
Measure	Abemaciclib and Pembrolizumab Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Study Treatment STARTED	3
Study Treatment COMPLETED	1
Study Treatment NOT COMPLETED	2
Follow up STARTED	3
Follow up COMPLETED	0
Follow up NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Abemaciclib and Pembrolizumab Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Study Treatment Disease Progression	1
Study Treatment Symptomatic Deterioration	1
Follow up Death	2
Follow up study terminated	1

Baseline Characteristics

Abemaciclib and Pembrolizumab in Locally Advanced Unresectable or Metastatic Gastroesophageal Adenocarcinoma: Big Ten Cancer Research Consortium BTCRC-GI18-149

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Abemaciclib and Pembrolizumab n=3 Participants Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Age, Continuous	68 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 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	3 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
ECOG Performance Status (Baseline) 0	3 Participants n=5 Participants
ECOG Performance Status (Baseline) 1	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: From C1D1 until death or up to a maximum of 5 months

Population: Only one subject was assessed per RECIST 1.1 in this trial. Therefore the progression free survival time of only one subject is reported here.

Outcome measures

Outcome measures
Measure	Abemaciclib and Pembrolizumab n=1 Participants Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Progression-Free Survival(PFS)	NA months Standard Deviation NA Mean and standard deviation could not be determined due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 5 months

Population: Only one subject was assessed per RECIST 1.1 in this trial. Therefore the progression free survival time of only one subject is reported here.

A measurement from the date of the start of treatment until the criteria for disease progression is met as defined by irRECIST or death occurs.Progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. The appearance of new lesions is not considered PD but are to be included in the sum diameters. Confirmation required at least 4 weeks after the first irPD assessment provided the patient is considered clinically stable.

Outcome measures

Outcome measures
Measure	Abemaciclib and Pembrolizumab n=1 Participants Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
PFS Per irRECIST	NA months Standard Deviation NA Mean and standard deviation could not be determined due to absence of participants with events.

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 6 months

Population: Only one subject was assessed per RECIST 1.1 in this trial. Therefore the progression free survival time of only one subject is reported here.

6 months PFS rate is defined as the proportion of subjects who have experienced no progressive disease or death at a 6 month time point from time of treatment initiation using RECIST and irRECIST criteria. Progressive disease per RECIST 1.1 and irRECIST is defined as at least a 20% increase in the sum of the diameters of target lesions,taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm. Per RECIST 1.1, the appearance of one or more new lesions is also considered progression. Per irRECIST, confirmation is required at least 4 weeks after the first irPD assessment provided the patient is considered clinically stable.

Outcome measures

Outcome measures
Measure	Abemaciclib and Pembrolizumab n=1 Participants Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Progression-Free Survival Rate at 6 Months Per RECIST 1.1 and irRECIST RECIST 1.1	NA months Standard Deviation NA Mean and standard deviation could not be determined due to insufficient number of participants with events.
Progression-Free Survival Rate at 6 Months Per RECIST 1.1 and irRECIST irRECIST	NA months Standard Deviation NA Mean and standard deviation could not be determined due to absence of participants with events.

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 5 months

Population: Only one subject was assessed per RECIST 1.1 in this trial and only one assessment of PD was recorded.

Objective response rate is the proportion of all subjects with confirmed PR or CR according to RECIST 1.1 and irRECIST criteria, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment).Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR/irCR), Disappearance of all target lesions; Partial Response (PR/irPR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Abemaciclib and Pembrolizumab n=1 Participants Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Objective Response Rate RECIST 1.1	0 Participants
Objective Response Rate irRECIST	0 Participants

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 5 months

Population: Only one subject was assessed per RECIST 1.1 in this trial and only one assessment of PD was recorded.

The disease control rate is the proportion of all subjects with stable disease (SD) for 16 weeks, or partial response (PR), or complete response (CR) according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment). RECIST and irRECIST criteria will be applied. Partial response is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Complete response is defined as disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to \<10 mm. Stable disease is defined neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Outcome measures

Outcome measures
Measure	Abemaciclib and Pembrolizumab n=1 Participants Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Disease Control Rate RECIST 1.1	0 Participants
Disease Control Rate irRECIST	0 Participants

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 5 months

Overall survival is defined by the duration of subject's survival from the start of treatment till death from any cause or off- study.

Outcome measures

Outcome measures
Measure	Abemaciclib and Pembrolizumab n=1 Participants Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Overall Survival	1.84 months

SECONDARY outcome

Timeframe: From C1D1 until death or up to a maximum of 5 months

Safety and tolerability of abemaciclib in combination with pembrolizumab in patients with advanced, unresectable or metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma, assessed by NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.

Outcome measures

Outcome measures
Measure	Abemaciclib and Pembrolizumab n=3 Participants Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Number of Participants With Specified Safety and Tolerability of Abemaciclib in Combination With Pembrolizumab Number of patients had at least one adverse event of any toxicity grade	3 Participants
Number of Participants With Specified Safety and Tolerability of Abemaciclib in Combination With Pembrolizumab Number of patients had at least one toxicity of grade 3 or greater adverse event	2 Participants
Number of Participants With Specified Safety and Tolerability of Abemaciclib in Combination With Pembrolizumab Number of patients had at least one grade 3 or greater treatment related adverse event	2 Participants
Number of Participants With Specified Safety and Tolerability of Abemaciclib in Combination With Pembrolizumab Number of patients having serious adverse event	2 Participants

Adverse Events

Abemaciclib and Pembrolizumab

Serious events: 2 serious events

Other events: 3 other events

Deaths: 2 deaths

Serious adverse events

Serious adverse events
Measure	Abemaciclib and Pembrolizumab n=3 participants at risk Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Gastrointestinal disorders DUODENAL HEMORRHAGE	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders GENERALIZED EDEMA	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders SEIZURE	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Other adverse events

Other adverse events
Measure	Abemaciclib and Pembrolizumab n=3 participants at risk Pembrolizumab was planned to be administered intravenously (IV) at a dose of 200mg on day 1 of each cycle. Abemaciclib was planned to be administered orally twice a day on each day of the cycle, 150 mg per dose.
Gastrointestinal disorders ABDOMINAL PAIN	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations ALKALINE PHOSPHATASE INCREASED	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Skin and subcutaneous tissue disorders ALOPECIA	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Blood and lymphatic system disorders ANEMIA	66.7% 2/3 • Number of events 3 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders ANOREXIA	66.7% 2/3 • Number of events 3 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders CONSTIPATION	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations CREATININE INCREASED	33.3% 1/3 • Number of events 5 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Psychiatric disorders DEPRESSION	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DIARRHEA	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DYSPEPSIA	66.7% 2/3 • Number of events 2 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders DYSPHAGIA	33.3% 1/3 • Number of events 2 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders EDEMA LIMBS	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
General disorders FATIGUE	66.7% 2/3 • Number of events 2 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Metabolism and nutrition disorders HYPOKALEMIA	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders NAUSEA	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders NERVOUS SYSTEM DISORDERS - OTHER, SPECIFY	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations NEUTROPHIL COUNT DECREASED	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	66.7% 2/3 • Number of events 2 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations PLATELET COUNT DECREASED	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Vascular disorders THROMBOEMBOLIC EVENT	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Infections and infestations THRUSH	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Renal and urinary disorders URINE DISCOLORATION	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Gastrointestinal disorders VOMITING	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations WEIGHT LOSS	33.3% 1/3 • Number of events 2 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Investigations WHITE BLOOD CELL DECREASED	33.3% 1/3 • Number of events 1 • Adverse events were assessed from time of signed informed consent for up to 5 months or until 30 days after discontinuation of study drug(s) or unacceptable toxicity. All-Cause Mortality was assessed from time of signed informed consent for up to 5 months or until death. An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Additional Information

Clinical Data Analyst

Hoosier Cancer Research Network

Phone: 3179212050

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place