Trial Outcomes & Findings for ECI301 and Radiation for Advanced or Metastatic Cancer (NCT NCT01441115)
NCT ID: NCT01441115
Last Updated: 2021-12-28
Results Overview
MTD is defined as the highest dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) during treatment or the first three weeks after treatment, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. Examples of DLT is any grade 3 or greater non-hematologic toxicity, ang grade 3 neutropenia or thrombocytopenia, any grade 4 anemia, and toxicity requiring a cumulative radiation treatment delay of 4 or more days.
TERMINATED
PHASE1
2 participants
During treatment or the first three weeks after treatment
2021-12-28
Participant Flow
Participant milestones
| Measure |
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
|---|---|
|
Overall Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
|---|---|
|
Overall Study
Taken off study - Principal Investigator discretion
|
1
|
Baseline Characteristics
ECI301 and Radiation for Advanced or Metastatic Cancer
Baseline characteristics by cohort
| Measure |
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
n=2 Participants
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
60.1 years
STANDARD_DEVIATION 9.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
2 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
|
2 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
|
1 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During treatment or the first three weeks after treatmentPopulation: This MTD was not found because the trial was terminated early. A trial using ECI301 \& radiation was initiated in Japan in 2012. This tested the primary endpoint in a duplicate trial, thus the study was closed. In addition, as specified in the protocol, the number of participants required to complete this trial involves 5 cohorts of 3 to 6 participants.
MTD is defined as the highest dose level at which no more than 1 of 6 participants experience dose-limiting toxicity (DLT) during treatment or the first three weeks after treatment, and the dose below that at which at least 2 (of ≤6) participants have DLT as a result of the drug. Examples of DLT is any grade 3 or greater non-hematologic toxicity, ang grade 3 neutropenia or thrombocytopenia, any grade 4 anemia, and toxicity requiring a cumulative radiation treatment delay of 4 or more days.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.Population: 1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and the Radiation Therapy Oncology Group (RTOG) criteria.
Outcome measures
| Measure |
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
n=1 Participants
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
Unlikely Related
n=1 Participants
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
Possibly Related
n=1 Participants
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
|---|---|---|---|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Lymphocyte count decreased
|
1 Adverse events
|
0 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Pain in extremity
|
1 Adverse events
|
0 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Urinary tract infection
|
0 Adverse events
|
0 Adverse events
|
1 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Alanine aminotransferase increased
|
0 Adverse events
|
1 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Anemia
|
4 Adverse events
|
0 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Aspartate aminotransferase increased
|
0 Adverse events
|
1 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Edema limbs
|
1 Adverse events
|
0 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Erythema multiforme
|
0 Adverse events
|
0 Adverse events
|
1 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Gastritis
|
0 Adverse events
|
1 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Headache
|
1 Adverse events
|
0 Adverse events
|
0 Adverse events
|
|
Number of Adverse Events Unrelated, Unlikely, and Possibly Related to ECI301 Delivered in Combination With 30 Gray (Gy) of External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Hyperkalemia
|
0 Adverse events
|
1 Adverse events
|
0 Adverse events
|
SECONDARY outcome
Timeframe: Before and after completion of ECI301Population: This outcome measure was not done because the trial was terminated early. A trial using ECI301 \& radiation was initiated in Japan in 2012. This tested the primary endpoint in a duplicate trial, thus the study was closed. In addition, as specified in the protocol, the number of participants required to complete this trial involves 5 cohorts of 3 to 6 participants.
Measurement of circulating precursor dendritic cells, circulating macrophage inflammatory protein-1 alpha (MIP-α), and assessment of T-lymphocytes will be measured by flow cytometry and assays for type II interferon (IFNγ) production.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Following the intravenous dose of ECI301Population: This outcome measure was not done because the trial was terminated early. A trial using ECI301 \& radiation was initiated in Japan in 2012. This tested the primary endpoint in a duplicate trial, thus the study was closed. In addition, as specified in the protocol, the number of participants required to complete this trial involves 5 cohorts of 3 to 6 participants.
Pharmacologic parameters will be derived using non-compartmental analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: 1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
Response will be measured by the Response Evaluation Criteria in Solid Tumors (RECIST). Complete response is disappearance of all target lesions. Partial response is at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease is at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The appearance of one or more new lesions is also considered progression. Stable disease is neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease.
Outcome measures
| Measure |
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
n=1 Participants
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
Unlikely Related
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
Possibly Related
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
|---|---|---|---|
|
Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301
Complete Response
|
0 Participants
|
—
|
—
|
|
Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301
Partial Response
|
0 Participants
|
—
|
—
|
|
Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301
Stable Disease
|
1 Participants
|
—
|
—
|
|
Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301
Progressive Disease
|
0 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.Population: 1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
Here is the number of participants with non-serious adverse events assessed by the Common Terminology Criteria for 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
| Measure |
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
n=1 Participants
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
Unlikely Related
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
Possibly Related
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
|---|---|---|---|
|
Here is the Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0)
|
1 Participants
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: During treatment or the first three weeks after treatmentPopulation: 1/2 participants was analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
Examples of DLT is any grade 3 or greater non-hematologic toxicity, any grade 3 neutropenia or thrombocytopenia, any grade 4 anemia; nausea, vomiting, diarrhea, tumor pain, or pre-existing hyponatremia, dyselectrolytemia, or orthostatic hypotension that has been optimally treated with anti-emetics, anti-diarrheal, analgesics, or hydration and which persists for over 48 hours despite maximal medical therapy, and toxicity requiring a cumulative radiation treatment delay of 4 or more days.
Outcome measures
| Measure |
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
n=1 Participants
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
Unlikely Related
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
Possibly Related
ECI301 Dose level 1 - 25 ug/kg and radiation therapy for advanced or metastatic cancer.
|
|---|---|---|---|
|
Number of Participants With a Dose-Limiting Toxicity (DLT)
|
0 Participants
|
—
|
—
|
Adverse Events
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
n=1 participants at risk
ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
Radiation Therapy
ECI301
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
1/1 • Number of events 4 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
Investigations
Aspartate aminotransferase increased
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
General disorders
Edema limbs
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
Gastrointestinal disorders
Gastritis
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
Nervous system disorders
Headache
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
|
Infections and infestations
Urinary tract infection
|
100.0%
1/1 • Number of events 1 • Date treatment consent signed to date off study, and up to 30 days following the last dose of study drug, approximately 5 months and 25 days.
1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place