CancerPhase 1NCT01441115

ECI301 and Radiation for Advanced or Metastatic Cancer

A Phase 1 study testing Radiation Therapy and ECI301 in people with Cancer and Neoplasm Metastasis, run by National Cancer Institute (NCI) at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Background: ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Cancer, Neoplasm Metastasis, Radiation Oncology
What is being tested?: Radiation Therapy and ECI301
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 6 Sep 2011to 24 Apr 2013
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

2.1.1.1 Age greater than or equal to18 years.
2.1.1.2 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
2.1.1.3 Life expectancy of greater than 3 months
2.1.1.4 Histologically confirmed cancer
2.1.1.5 Extracranial metastatic cancer or locally advanced cancer for which palliative radiotherapeutic management would be appropriate (no more than two sites will be treated on this trial)
2.1.1.6 Patients must have measurable or evaluable disease at the site(s) requiring radiation

Show all 17Show fewer

2.1.1.7 Adequate marrow and organ function defined as
absolute neutrophil count (ANC) > 1.5 times 10(9)/L,
platelet count > 100 times 10(9),
hemoglobin >9 g/L.
creatinine clearance greater than or equal to 60 mL/min/1.73 m(2) for patients with creatinine levels above institutional normal
serum bilirubin <1.5 times upper limit reference range (ULRR),
alanine aminotransferase (ALT), aspartate aminotransferase (AST), or
alkaline phosphatase (ALP) <2.5 times the ULRR (<5 times the ULRR in the presence
of liver metastases)
2.1.1.8 Female patients of childbearing potential must either be surgically sterile to prevent pregnancy, be at least 1-year post-menopausal, or have had no menses for 12 months, or agree to use reliable methods of contraception (oral contraceptives, barrier methods, approved contraceptive implant, long-term injectable contraception, copper banded intrauterine device, tubal ligation or abstinence) from time of screening until 4 weeks after discontinuing study treatment. It is not known whether ECI301 has the capacity to induce hepatic enzymes so hormonal contraceptives should be combined with a barrier method of contraception.
2.1.1.9 Male patients must agree to use barrier contraception (i.e. condoms) and refrain from donating sperm from the start of dosing until 16 weeks after discontinuing study treatment. If male patients wish to father children, they should be advised to arrange for freezing of sperm prior to the start of study treatment.

Who cannot join

2.1.2.1 Pregnant or lactating females
2.1.2.2 Contraindications to radiotherapy (i.e. prior radiotherapy to the intended treatment site)
2.1.2.3 Untreated or previously treated but progressive intracranial metastases (Patients with previously treated intracranial metastases should have no clinical evidence of progression and be at least 4 weeks from therapy for intracranial metastases)
2.1.2.4 Need for emergent radiotherapy (defined as need for radiotherapy within 24 hours of consultation at the judgment of the treating radiation oncologist)
2.1.2.5 Active treatment with immunosuppressive therapy and subjects taking systemic corticosteroid therapy for any reason including replacement therapy for hypoadrenalism
2.1.2.6 Chemotherapy, radiation therapy, Tamoxifen or investigational therapy during the 4 weeks prior to initiation of protocol therapy

Show all 11Show fewer

2.1.2.7 History of rheumatoid arthritis, systemic lupus erythematosus, Sjogren's disease, sarcoidosis, vasculitis, polymyositis, temporal arteritis or any other autoimmune disease
2.1.2.8 History of organ transplant
2.1.2.9 Human immunodeficiency virus (HIV), Hepatitis B, or Hepatitis C positivity
2.1.2.10 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
2.1.2.11 Use of excluded immune modulating medications within 4 weeks prior to protocol therapy, or requirement for concurrent use.

Trial locations and contacts

1 site in 1 country.

United States1 site

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892

Other trials in United States

About this study

Official title: Phase I Trial of ECI301 in Combination With Radiation in Patients With Advanced or Metastatic Cancer

Background:

ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Researchers want to study ECI301 in people with advanced cancer or cancer that has spread in the body (metastatic).

Objectives:

To test ECI301 with radiation therapy for advanced or metastatic cancer.

Eligibility:

People at least 18 years of age with either metastatic or advanced cancer that may benefit from radiation therapy.

Design:

Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies.
All participants will have radiation therapy 5 days a week for 2 weeks.
They will have different doses of ECI301 to test its safety and effectiveness. ECI301 will be given in a vein during the second week of radiation therapy. Frequent blood tests and imaging studies will monitor the treatment.
After participants have ECI301, tumor samples may be taken from the site that had radiation and another site that did not have radiation.
Follow-up visits will include blood tests and imaging studies.

Read the detailed description

Background:

Patients with metastatic or locally advanced cancer frequently require palliative radiotherapy to relieve symptoms; however, progression of disease is frequent in patients with extended survival
Radiation results in tumor cell death which can result in increased dendritic cell activation and trafficking
ECI301 is a derivative of Macrophage Inflammatory Protein-1 alpha, a 70 amino acid chemokine that is a ligand for C-C chemokine receptor type 1 (CCR1) and C-C chemokine receptor type 5 (CCR5), the chemokine receptors of immature dendritic cells.
ECI301 has been shown to enhance the effect of radiotherapy in animal models.

Objectives:

The primary objective is to determine the maximum tolerated dose (MTD) of ECI301 delivered in combination with 30 Gray (Gy) of external beam radiation to patients with metastatic or locally advanced cancer.
The secondary objectives are:
To describe the safety and tolerability of ECI301 delivered in combination with 30 Gy of external beam radiation to patients with metastatic or locally advanced cancer
To evaluate the humoral and cellular immune responses by:
Measurement of circulating precursor dendritic cells before and after the completion of ECI301
Measurement of circulating MIP-alpha before and after the completion of ECI301
Assessment of T-lymphocyte quantitative and qualitative changes by flow cytometry and assays for interferon (IFN-gamma) production
To define pharmacologic parameters following the intravenous dose of ECI301
To determine if neutralizing anti-EC301 antibodies occur after treatment
To describe the response at the radiated site and distant sites after radiation in combination with ECI301

Eligibility:

Age >18 years.
Eastern Cooperative Oncology Group (ECOG) performance status <2.
Life expectancy of greater than 3 months
Histologically confirmed metastatic or locally advanced cancer for which radiotherapeutic management would be appropriate
No recent history of myocardial infarction or unstable angina

Design:

This is a Phase I trial to determine the maximum tolerated dose of ECI301 in combination with external beam radiation therapy in patients with locally advanced or metastatic solid tumors.
Patients will be treated with radiation therapy in a standard manner with ECI301 given daily during radiation. The dose of ECI301 will be escalated over the course of the trial to determine the maximum tolerated dose (MTD of daily ECI301 in combination with radiotherapy.
We anticipate that accrual to this trial of 30 patients will take approximately 2 years.

Conditions: Cancer, Neoplasm Metastasis, Radiation Oncology, Neoplasm, Metastasis
Being tested: Radiation Therapy, ECI301
Keywords: Metastasis, Cancer, Radiation Therapy, Locally Advanced, Palliation, Metastatic Cancer
Medical subject headings: Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Radiation TherapyProcedure or surgery
ECI301Drug

Study groups in NCT01441115
Study group	Role	What they receive
ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	Experimental	ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer Receives: Procedure: Radiation Therapy; Drug: ECI301

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Tolerated Dose (MTD) of ECI301 Delivered in Combination With 30 Gray (Gy) External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
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.
Measured: During treatment or the first three weeks after treatment

Secondary outcomes (4)

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
Adverse events were assessed by the Common Terminology Criteria for Adverse Events (CTCAE v4.0) and the Radiation Therapy Oncology Group (RTOG) criteria.
Measured: 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.
Humoral and Cellular Immune Responses
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.
Measured: Before and after completion of ECI301
Pharmacologic Parameters Following the Intravenous Dose of ECI301
Pharmacologic parameters will be derived using non-compartmental analysis.
Measured: Following the intravenous dose of ECI301
Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Sep 201124 Apr 2013

First posted27 Sep 2011 (estimated)
Study start6 Sep 2011
Primary completion24 Apr 2013
Study completion24 Apr 2013

Why it stopped: 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for CancerStudies of the same condition, open and under way.
More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01441115
Sponsor's protocol ID: 110248
Other IDs: 11-C-0248
Status last verified: Nov 2021
First submitted: 24 Sep 2011
Last updated: 28 Dec 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Friedman EJ. Immune modulation by ionizing radiation and its implications for cancer immunotherapy. Curr Pharm Des. 2002;8(19):1765-80. doi: 10.2174/1381612023394089.
PubMed 12171547
Sharp HJ, Wansley EK, Garnett CT, Chakraborty M, Camphausen K, Schlom J, Hodge JW. Synergistic antitumor activity of immune strategies combined with radiation. Front Biosci. 2007 Sep 1;12:4900-10. doi: 10.2741/2436.
PubMed 17569618
Maurer M, von Stebut E. Macrophage inflammatory protein-1. Int J Biochem Cell Biol. 2004 Oct;36(10):1882-6. doi: 10.1016/j.biocel.2003.10.019.
PubMed 15203102

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I Trial of ECI301 in Combination With Radiation in Patients With Advanced or Metastatic Cancer
ClinicalTrials.gov ID: NCT01441115
Acronym / sponsor ID: 110248
Conditions: Cancer, Neoplasm Metastasis, Radiation Oncology, Neoplasm, Metastasis
Keywords: Metastasis, Cancer, Radiation Therapy, Locally Advanced, Palliation, Metastatic Cancer
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: 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.
Enrolment: 2 participants (actual)
Lead sponsor: National Cancer Institute (NCI)US National Institutes of Health
Study start: 6 Sep 2011 (actual)
Primary completion: 24 Apr 2013 (actual)
Study completion: 24 Apr 2013 (actual)
First posted: 27 Sep 2011 (estimated)
Results: Posted 28 Dec 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Background:

ECI301 is a drug that may help make cancer cells more visible to the immune system after radiation. The drug may also help the immune system destroy the cancer at sites that have not received radiation therapy. Researchers want to study ECI301 in people with advanced cancer or cancer that has spread in the body (metastatic).

Objectives:

To test ECI301 with radiation therapy for advanced or metastatic cancer.

Eligibility:

People at least 18 years of age with either metastatic or advanced cancer that may benefit from radiation therapy.

Design:

Participants will be screened with a medical history and physical exam. They will also have blood and urine tests, and imaging studies.
All participants will have radiation therapy 5 days a week for 2 weeks.
They will have different doses of ECI301 to test its safety and effectiveness. ECI301 will be given in a vein during the second week of radiation therapy. Frequent blood tests and imaging studies will monitor the treatment.
After participants have ECI301, tumor samples may be taken from the site that had radiation and another site that did not have radiation.
Follow-up visits will include blood tests and imaging studies.

Detailed description

Background:

Patients with metastatic or locally advanced cancer frequently require palliative radiotherapy to relieve symptoms; however, progression of disease is frequent in patients with extended survival
Radiation results in tumor cell death which can result in increased dendritic cell activation and trafficking
ECI301 is a derivative of Macrophage Inflammatory Protein-1 alpha, a 70 amino acid chemokine that is a ligand for C-C chemokine receptor type 1 (CCR1) and C-C chemokine receptor type 5 (CCR5), the chemokine receptors of immature dendritic cells.
ECI301 has been shown to enhance the effect of radiotherapy in animal models.

Objectives:

The primary objective is to determine the maximum tolerated dose (MTD) of ECI301 delivered in combination with 30 Gray (Gy) of external beam radiation to patients with metastatic or locally advanced cancer.
The secondary objectives are:
To describe the safety and tolerability of ECI301 delivered in combination with 30 Gy of external beam radiation to patients with metastatic or locally advanced cancer
To evaluate the humoral and cellular immune responses by:
Measurement of circulating precursor dendritic cells before and after the completion of ECI301
Measurement of circulating MIP-alpha before and after the completion of ECI301
Assessment of T-lymphocyte quantitative and qualitative changes by flow cytometry and assays for interferon (IFN-gamma) production
To define pharmacologic parameters following the intravenous dose of ECI301
To determine if neutralizing anti-EC301 antibodies occur after treatment
To describe the response at the radiated site and distant sites after radiation in combination with ECI301

Eligibility:

Age >18 years.
Eastern Cooperative Oncology Group (ECOG) performance status <2.
Life expectancy of greater than 3 months
Histologically confirmed metastatic or locally advanced cancer for which radiotherapeutic management would be appropriate
No recent history of myocardial infarction or unstable angina

Design:

This is a Phase I trial to determine the maximum tolerated dose of ECI301 in combination with external beam radiation therapy in patients with locally advanced or metastatic solid tumors.
Patients will be treated with radiation therapy in a standard manner with ECI301 given daily during radiation. The dose of ECI301 will be escalated over the course of the trial to determine the maximum tolerated dose (MTD of daily ECI301 in combination with radiotherapy.
We anticipate that accrual to this trial of 30 patients will take approximately 2 years.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	Experimental	Procedure: Radiation Therapy, Drug: ECI301ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (17 listed)

2.1.1.1 Age greater than or equal to18 years.
2.1.1.2 Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.
2.1.1.3 Life expectancy of greater than 3 months
2.1.1.4 Histologically confirmed cancer
2.1.1.5 Extracranial metastatic cancer or locally advanced cancer for which palliative radiotherapeutic management would be appropriate (no more than two sites will be treated on this trial)

Key exclusion criteria (11 listed)

2.1.2.1 Pregnant or lactating females
2.1.2.2 Contraindications to radiotherapy (i.e. prior radiotherapy to the intended treatment site)
2.1.2.3 Untreated or previously treated but progressive intracranial metastases (Patients with previously treated intracranial metastases should have no clinical evidence of progression and be at least 4 weeks from therapy for intracranial metastases)
2.1.2.4 Need for emergent radiotherapy (defined as need for radiotherapy within 24 hours of consultation at the judgment of the treating radiation oncologist)
2.1.2.5 Active treatment with immunosuppressive therapy and subjects taking systemic corticosteroid therapy for any reason including replacement therapy for hypoadrenalism

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Radiation Therapy	Procedure or surgery	ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer
ECI301	Drug	ECI301 Dose level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer

Primary outcome

Maximum Tolerated Dose (MTD) of ECI301 Delivered in Combination With 30 Gray (Gy) External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer
Time frame: 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.

4 secondary outcomes

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
Time frame: 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.
Humoral and Cellular Immune Responses
Time frame: Before and after completion of ECI301
Pharmacologic Parameters Following the Intravenous Dose of ECI301
Time frame: Following the intravenous dose of ECI301
Number of Participants With Response at the Radiated Site and Distant Site After Radiation in Combination With ECI301
Time frame: 6 months

Results and safety

Results posted to the registry on 28 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	2	1

Primary outcome: Maximum Tolerated Dose (MTD) of ECI301 Delivered in Combination With 30 Gray (Gy) External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer

Time frame: During treatment or the first three weeks after treatment

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ECI301 Dose Level 1 - 25 ug/kg and Radiation for Advanced or Metastatic Cancer	0 of 1 (0%)	1 of 1 (100%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12171547Friedman EJ. Immune modulation by ionizing radiation and its implications for cancer immunotherapy. Curr Pharm Des. 2002;8(19):1765-80. doi: 10.2174/1381612023394089.
Background: PubMed 17569618Sharp HJ, Wansley EK, Garnett CT, Chakraborty M, Camphausen K, Schlom J, Hodge JW. Synergistic antitumor activity of immune strategies combined with radiation. Front Biosci. 2007 Sep 1;12:4900-10. doi: 10.2741/2436.
Background: PubMed 15203102Maurer M, von Stebut E. Macrophage inflammatory protein-1. Int J Biochem Cell Biol. 2004 Oct;36(10):1882-6. doi: 10.1016/j.biocel.2003.10.019.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Deborah E Citrin, M.D. principal investigator

National Cancer Institute (NCI)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Radiation Therapy and ECI301 in people with Cancer and Neoplasm Metastasis, run by National Cancer Institute (NCI) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (MTD) of ECI301 Delivered in Combination With 30 Gray (Gy) External Beam Radiation to Participants With Metastatic or Locally Advanced Cancer (time frame: During treatment or the first three weeks after treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01441115, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2021.