Trial Outcomes & Findings for Phase II PEMBROLIZUMAB + PALLIATIVE RADIOTHERAPY IN BC (NCT NCT03051672)

Last Updated: 2021-04-27

Results Overview

The objective response rate (ORR) was defined as the proportion of participants achieving complete response (CR) or partial response (PR) outside the field of radiation based on RECIST 1.1 criteria on treatment. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Tumor measurements are repeated every 6 weeks for the first 24 weeks and then every 9 weeks thereafter. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was 1 cycle. Response was evaluated up to 3 months.

Results posted on

2021-04-27

Participant Flow

Patients enrolled from May, 2017 to July, 2018.

Participant milestones

Participant milestones
Measure	Pembrolizumab With Radiation Pembrolizumab will be administered intravenously prior to radiation pembrolizumab : 200 mg intravenously 2 to 7 days prior to radiotherapy (RT) and on day 1 of repeating 21-day cycles. Palliative radiation: a total dose of 20 Gy in 5 fractions
Overall Study STARTED	8
Overall Study Began Treatment	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase II PEMBROLIZUMAB + PALLIATIVE RADIOTHERAPY IN BC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pembrolizumab With Radiation n=8 Participants * Pembrolizumab will be administered intravenously prior to radiation * Pembrolizumab will be administered every 21 days * Palliative radiotherapy will be given for 5 treatments
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 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	8 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 at Baseline 0 - Normal activity	2 Participants n=5 Participants
ECOG Performance Status at Baseline 1 - Symptoms, but ambulatory	6 Participants n=5 Participants
ECOG Performance Status at Baseline 2 - In bed <50% of the time	0 Participants n=5 Participants
Site of Disease CNS	0 case n=5 Participants
Site of Disease Lung or pleural effusion	2 case n=5 Participants
Site of Disease Liver	5 case n=5 Participants
Site of Disease Bone	8 case n=5 Participants
Site of Disease Breast or chest wall	1 case n=5 Participants
Site of Disease Lymph nodes	1 case n=5 Participants
Site of Disease Soft tissue	0 case n=5 Participants
Site of Disease Other	2 case n=5 Participants

PRIMARY outcome

Timeframe: Tumor measurements are repeated every 6 weeks for the first 24 weeks and then every 9 weeks thereafter. Treatment continued until disease progression or unacceptable toxicity. Treatment duration was 1 cycle. Response was evaluated up to 3 months.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Radiation n=8 Participants * Pembrolizumab will be administered intravenously prior to radiation * Pembrolizumab will be administered every 21 days * Palliative radiotherapy will be given for 5 treatments
Objective Response Rate	0 percentage of participants Interval 0.0 to 31.25

SECONDARY outcome

All grade 4 adverse events (AE) with treatment attribution of possibly, probably or definite based on CTCAEv3 as reported on case report forms were counted. Incidence is the number of patients experiencing at least one treatment-related grade 4 AE of any type during the time of observation.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Radiation n=8 Participants * Pembrolizumab will be administered intravenously prior to radiation * Pembrolizumab will be administered every 21 days * Palliative radiotherapy will be given for 5 treatments
Incidence of Grade 4 Treatment-Related Toxicity	0 participants

SECONDARY outcome

Progression-free survival based on the Kaplan-Meier method is defined as the duration of time from study entry to documented disease progression (PD) or death. Per RECIST 1.1 criteria: progressive disease (PD) is at least a 20% increase in the sum of longest diameter (LD) of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. PD for the evaluation of non-target lesions is the appearance of one or more new lesions and/or unequivocal progression of non-target lesions.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Radiation n=8 Participants * Pembrolizumab will be administered intravenously prior to radiation * Pembrolizumab will be administered every 21 days * Palliative radiotherapy will be given for 5 treatments
Median Progression-free Survival (PFS)	1.4 months Interval 0.4 to 2.1

SECONDARY outcome

OS based on the Kaplan-Meier method is defined as the time from study entry to death or censored at date last known alive.

Outcome measures

Outcome measures
Measure	Pembrolizumab With Radiation n=8 Participants * Pembrolizumab will be administered intravenously prior to radiation * Pembrolizumab will be administered every 21 days * Palliative radiotherapy will be given for 5 treatments
Median Overall Survival (OS)	2.9 Months Interval 0.9 to 3.6

Adverse Events

Pembrolizumab With Radiation

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pembrolizumab With Radiation n=8 participants at risk Pembrolizumab will be administered intravenously prior to radiation pembrolizumab : 200 mg intravenously 2 to 7 days prior to radiotherapy (RT) and on day 1 of repeating 21-day cycles. Palliative radiation: a total dose of 20 Gy in 5 fractions
Ear and labyrinth disorders Vertigo	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Febrile neutropenia	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Gastroesophageal reflux disease	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Metabolism and nutrition disorders - Other	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Blood and lymphatic system disorders Anemia	25.0% 2/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Endocrine disorders Hyperthyroidism	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Endocrine disorders Hypothyroidism	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Eye disorders Eye disorders - Other, specify	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Abdominal pain	25.0% 2/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Constipation	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Diarrhea	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Gastritis	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Nausea	25.0% 2/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Gastrointestinal disorders Vomiting	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Fatigue	62.5% 5/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Flu like symptoms	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
General disorders Pain	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Infections and infestations Upper respiratory infection	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Alanine aminotransferase increased	25.0% 2/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Aspartate aminotransferase increased	50.0% 4/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Investigations Platelet count decreased	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Anorexia	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Metabolism and nutrition disorders Hyperglycemia	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Arthralgia	25.0% 2/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Back pain	25.0% 2/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Bone pain	25.0% 2/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Musculoskeletal and connective tissue disorders Osteoporosis	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Headache	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Nervous system disorders Peripheral motor neuropathy	25.0% 2/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Psychiatric disorders Anxiety	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Respiratory, thoracic and mediastinal disorders Dyspnea	25.0% 2/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.
Skin and subcutaneous tissue disorders Hyperhidrosis	12.5% 1/8 • AE data collected every cycle (21 days) from time of the first dose of study treatment, through the study and until removal from study or death, whichever occurs first. AEs were observed up to 3 months. Serious AEs (SAE) were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher. All remaining AEs are classified as Other AEs (OAE) including grade 3 or higher events with treatment-attribution of unlikely and unrelated plus all grade 1 and 2 events. Maximum grade toxicity by type was then calculated within SAE and OAE datasets. No further data is available to specify classification of other beyond the general term.

Additional Information

Dr. Sara Tolaney

Dana-Farber Cancer Institute

Phone: 6176323800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place