Trial · NCT01441115
ECI301 and Radiation for Advanced or Metastatic Cancer
NCT01441115, Phase 1, Terminated, National Cancer Institute (NCI); results first posted 2021-12-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. ECI301 and Radiation for Advanced or Metastatic Cancer. Trials, record NCT01441115. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01441115
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ECI301 and Radiation for Advanced or Metastatic Cancer
- NCT number
- NCT01441115
- Status
- Terminated
- Phases
- Phase 1
- Enrollment
- 2 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Cancer, Neoplasm Metastasis, Radiation Oncology, Neoplasm, Metastasis
- Interventions
- Radiation Therapy, ECI301
- First posted
- 2011-09-27
- Last updated
- 2021-12-28
- Results first posted
- 2021-12-28
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of ECI301 Delivered in Combination With 30 Gray (Gy) External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer | During treatment or the first three weeks after treatment | 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. |
| Secondary | 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 | 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. | Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and the Radiation Therapy Oncology Group (RTOG) criteria. |
| Secondary | Humoral and Cellular Immune Responses | Before and after completion of ECI301 | 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. |
| Secondary | Pharmacologic Parameters Following the Intravenous Dose of ECI301 | Following the intravenous dose of ECI301 | Pharmacologic parameters will be derived using non-compartmental analysis. |
| Secondary | Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301 | 6 months | 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. |
| Other | Here is the Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 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. | 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. |
| Other | Number of Participants With a Dose-Limiting Toxicity (DLT) | During treatment or the first three weeks after treatment | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of ECI301 Delivered in Combination With 30 Gray (Gy) External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer | During treatment or the first three weeks after treatment | 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. | ||
| SECONDARY | 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 | 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. | Adverse events | NUMBER |
| SECONDARY | Humoral and Cellular Immune Responses | Before and after completion of ECI301 | 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. | ||
| SECONDARY | Pharmacologic Parameters Following the Intravenous Dose of ECI301 | Following the intravenous dose of ECI301 | 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. | ||
| SECONDARY | Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301 | 6 months | 1/2 participants were analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Here is the Number of Participants With Non-Serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Number of Participants With a Dose-Limiting Toxicity (DLT) | During treatment or the first three weeks after treatment | 1/2 participants was analyzed because one participant was taken off study per Principal Investigator discretion and did not receive drug. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
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 | Unrelated | Alanine aminotransferase increased | 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 | Unlikely Related | Alanine aminotransferase increased | 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 | Possibly Related | Alanine aminotransferase increased | 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 | Unrelated | Anemia | 4 | 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 | Unlikely Related | Anemia | 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 | Possibly Related | Anemia | 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 | Unrelated | Aspartate aminotransferase increased | 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 | Unlikely Related | Aspartate aminotransferase increased | 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 | Possibly Related | Aspartate aminotransferase increased | 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 | Unrelated | Edema limbs | 1 | Adverse events |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 2 | |
| Overall Study | COMPLETED | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | |
| Overall Study | NOT COMPLETED | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 |
Source ClinicalTrials.gov
Adverse events11
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Alanine aminotransferase increased | Investigations | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 1 |
| other | Anemia | Blood and lymphatic system disorders | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 4 |
| other | Aspartate aminotransferase increased | Investigations | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 1 |
| other | Edema limbs | General disorders | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 1 |
| other | Erythema multiforme | Skin and subcutaneous tissue disorders | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 1 |
| other | Gastritis | Gastrointestinal disorders | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 1 |
| other | Headache | Nervous system disorders | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 1 |
| other | Hyperkalemia | Metabolism and nutrition disorders | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 1 |
| other | Lymphocyte count decreased | Investigations | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 1 |
| other | Pain in extremity | Musculoskeletal and connective tissue disorders | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 | 1 |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 0 | 1 |
| Total, other adverse events | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 1 | 1 |
| Total, serious adverse events | ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer | 0 | 1 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01441115
GET https://conductscience.org/api/trials/v1/NCT01441115/results?page=2