Trial Outcomes & Findings for Mithramycin for Lung, Esophagus, and Other Chest Cancers (NCT NCT01624090)

Last Updated: 2019-12-30

Results Overview

Objective response was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR) is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10mm. Partial Response (PR) is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD) is at least a 20% increase in the sum of the diameters of target lesion, 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). Stable Disease (SD) is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Every 8 weeks until disease progression or unacceptable toxicity, over an average of 4 months.

Results posted on

2019-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Dose Level 1 - 30 mcg/kg Thoracic Malignancy Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level -1 - 25 mcg/kg Thoracic Malignancy Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).	Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
Overall Study STARTED	2	2	10	2
Overall Study COMPLETED	2	0	3	2
Overall Study NOT COMPLETED	0	2	7	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level -1 - 25 mcg/kg Thoracic Malignancy Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
Overall Study DLT, taken off therapy	1	0
Overall Study Withdrew prior to treatment	1	0
Overall Study Died on study	0	2
Overall Study Did not complete 1 crse of therapy	0	2
Overall Study Dose escalated	0	3

Baseline Characteristics

Mithramycin for Lung, Esophagus, and Other Chest Cancers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Level 1 - 30 mcg/kg Thoracic Malignancy n=2 Participants Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy n=2 Participants Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level -1 - 25 mcg/kg Thoracic Malignancy n=10 Participants Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).	Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy n=2 Participants Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).	Total n=16 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	12 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants	0 Participants n=4 Participants	4 Participants n=21 Participants
Age, Continuous	67 years STANDARD_DEVIATION 1 • n=5 Participants	34.5 years STANDARD_DEVIATION 7.5 • n=7 Participants	59.1 years STANDARD_DEVIATION 9.65 • n=5 Participants	50.5 years STANDARD_DEVIATION 10.5 • n=4 Participants	56.86 years STANDARD_DEVIATION 12.60 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	9 Participants n=5 Participants	1 Participants n=4 Participants	14 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	10 Participants n=5 Participants	2 Participants n=4 Participants	15 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants	2 Participants n=4 Participants	13 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	2 Participants n=5 Participants	2 Participants n=7 Participants	10 Participants n=5 Participants	2 Participants n=4 Participants	16 Participants n=21 Participants

PRIMARY outcome

Timeframe: Every 8 weeks until disease progression or unacceptable toxicity, over an average of 4 months.

Population: One participant in DL1 30 mcg thoracic died on study, one participant in DL1 30 mcg extra thoracic experienced a dose limiting toxicity and was taken off therapy, and 1 withdrew prior to trmt, two participants in DL1 25 mcg thoracic died on study, and two did not complete one course of therapy prior to treatment evaluation for this outcome measure.

Outcome measures

Outcome measures
Measure	Dose Level 1 - 30 mcg/kg Thoracic Malignancy n=1 Participants Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level -1 - 25 mcg/kg Thoracic Malignancy n=6 Participants Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).	Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy n=2 Participants Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
Number of Participants With an Objective Response (Complete Response + Partial Response) Complete Response	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With an Objective Response (Complete Response + Partial Response) Partial Response	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With an Objective Response (Complete Response + Partial Response) Stable Disease	0 Participants	0 Participants	0 Participants	0 Participants
Number of Participants With an Objective Response (Complete Response + Partial Response) Progressive Disease	1 Participants	0 Participants	6 Participants	2 Participants

SECONDARY outcome

Timeframe: Date treatment consent signed to date off study, approx. 9 mos & 6 days DL1 30 mcg/kg thoracic group, 2 mos & 16 days DL1 30 mcg/kg extra-thoracic group, 5 mos & 26 days DL-1 25 mcg/kg thoracic group, & 20 days DL-1 25 mcg/kg extra-thoracic group

Population: One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.

Outcome measures

Outcome measures
Measure	Dose Level 1 - 30 mcg/kg Thoracic Malignancy n=2 Participants Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy n=1 Participants Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level -1 - 25 mcg/kg Thoracic Malignancy n=10 Participants Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).	Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy n=2 Participants Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
Number of Participants With Serious and Non-Serious Adverse Events	2 Participants	1 Participants	10 Participants	2 Participants

Adverse Events

Dose Level 1 - 30 mcg/kg Thoracic Malignancy

Serious events: 1 serious events

Other events: 2 other events

Deaths: 1 deaths

Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Dose Level -1 - 25 mcg/kg Thoracic Malignancy

Serious events: 2 serious events

Other events: 10 other events

Deaths: 2 deaths

Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dose Level 1 - 30 mcg/kg Thoracic Malignancy n=2 participants at risk Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level 1 - 30 mcg/kg Extra Thoracic Malignancy n=1 participants at risk Single agent intravenous (IV) mithramycin Mithramycin: 30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity.	Dose Level -1 - 25 mcg/kg Thoracic Malignancy n=10 participants at risk Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).	Dose Level -1 - 25 mcg/kg Extra Thoracic Malignancy n=2 participants at risk Single agent intravenous (IV) mithramycin Mithramycin: 25 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle).
Cardiac disorders Atrial flutter	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	10.0% 1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Cardiac disorders Cardiac arrest	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	10.0% 1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	10.0% 1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	10.0% 1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Metabolism and nutrition disorders Hyponatremia	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	10.0% 1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Infections and infestations Lung infection	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	10.0% 1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	10.0% 1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Vascular disorders Thromboembolic event	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	10.0% 1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Infections and infestations Urinary tract infection	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	10.0% 1/10 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Gastrointestinal disorders Esophageal perforation	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/10 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.
Nervous system disorders Syncope	50.0% 1/2 • Number of events 1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/1 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/10 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.	0.00% 0/2 • Date treatment consent signed to date off study, approximately 9 months and 6 days for the DL1 30 mcg/kg thoracic group, 2 months and 16 days for the DL1 30 mcg/kg extra-thoracic group, 5 months and 26 days for the DL-1 25 mcg/kg thoracic group, and 20 days for the DL-1 25 mcg/kg extra-thoracic group. One participant was enrolled in the 30 mcg/kg extra thoracic group but withdrew prior to treatment.

Other adverse events

Additional Information

Dr. David S. Schrump

National Cancer Institute

Phone: 240-858-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place