Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck CancerNCT01662284
Study of 124I-NM404 in Advanced Solid Malignancies
An observational study of Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to assess the use of investigational compound 124I-NM404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer
- What is being tested?
- 124I-NM404
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will be referred to the Phase I oncology research office by their treating oncologist. Outside referrals will be managed by Cancer Connect who will ensure that potential subjects are first evaluated by a UW medical oncologist in the cancer clinic who will then refer them, if appropriate, to the Phase I oncology office.
Who may be able to join
- Diagnosis of advanced solid malignancy.
- Allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head \& neck cancer
- Disease must be at least 1cm in diameter
- Brain metastasis must be stable for at least one month.
- ECOG performance status 0-2
- Anticipated survival less than 5 years, as per the treating physician
Who cannot join
- Skin lesions only
- Chemotherapy or radiotherapy within 1 week
- Residual toxicities of grade 2 or greater from prior therapy
- Adequate organ function as per specified laboratory parameter
- Platelet count > or = to 75,000/uL
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53792
About this study
Official title: A Phase 1/2 Study of 124I-NM404 in Subjects With Advanced Solid Malignancies
The purpose of this study is to assess the use of investigational compound 124I-NM404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body.
Read the detailed description
124I-NM404 is a new investigational agent being developed to better identify local tumors and cancerous tumors using imaging technologies such as positron emission tomography (PET) scans. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more accurately see and evaluate cancerous tumors. This agent has been safely studied in animals and a limited number of human patients with lung cancer. This study is being done to determine the best dose to use and to fully evaluate the images that result from using this new agent.
- Being tested
- 124I-NM404
- Medical subject headings
- Sarcoma, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
124I-NM404Drug
124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
| Study group | Role | What they receive |
|---|---|---|
| Triple Negative Breast | 124I-NM404 in triple negative breast cancer Receives: Drug: 124I-NM404 | |
| Prostate | 124I-NM404 in prostate cancer Receives: Drug: 124I-NM404 | |
| Colorectal | 124I-NM404 in colorectal cancer Receives: Drug: 124I-NM404 | |
| Gastric | 124I-NM404 in gastric cancer Receives: Drug: 124I-NM404 | |
| Ovarian | 124I-NM404 in ovarian cancer Receives: Drug: 124I-NM404 | |
| Pancreatic | 124I-NM404 in pancreatic cancer Receives: Drug: 124I-NM404 | |
| Esophageal | 124I-NM404 in esophageal cancer Receives: Drug: 124I-NM404 | |
| Sarcoma | 124I-NM404 in soft tissue sarcoma Receives: Drug: 124I-NM404 | |
| Head & Neck | 124I-NM404 in head and neck cancer Receives: Drug: 124I-NM404 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal Imaging Parameters
To determine the optimal imaging parameters (dose, acquisition time, imaging time post injection, normal organ and tumor dosimetry) of 124I-NM404 in subjects with advanced solid malignancies with one of the following tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head \& neck cancer
Measured: 2 years
Secondary outcomes (2)
Adverse events
Number and grade of adverse events attributable to 124I-NM-404
Measured: 2 years
PET comparison
compare 18F-FDG PET to 124I-NM404 PET
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJul 2012
- Primary completionMay 2016
- Study completionMay 2016
Why it stopped: Sponsor determined this trial does not support their anticipated clinical development program.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Cellectar Biosciences, Inc.
- Responsible party
- Sponsor
- Investigators
- Glenn Liu, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662284
- Sponsor's protocol ID
- CO12901
- Other IDs
- 2012-0230, A534260, SMPH\MEDICINE\HEM-ONC, NCI-2012-01953
- Status last verified
- Jan 2017
- First submitted
- 3 Aug 2012
- Last updated
- 21 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of 124I-NM404 in Subjects With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01662284
- Acronym / sponsor ID
- CO12901
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor determined this trial does not support their anticipated clinical development program.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Cellectar Biosciences, Inc.
- Study start
- Jul 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the use of investigational compound 124I-NM404 for accurate detection and characterization of a wide variety of solid primary and metastatic malignancies anywhere in the body.
Detailed description
124I-NM404 is a new investigational agent being developed to better identify local tumors and cancerous tumors using imaging technologies such as positron emission tomography (PET) scans. An investigational drug is a drug that has not been approved by the Food and Drug Administration (FDA) and is available for research use only. 124I-NM404 is only taken up by the cancer cells, not the normal cells. Compared to traditional methods such as CT (computed tomography) or MRI (Magnetic resonance imaging), 124I-NM404 may help physicians more accurately see and evaluate cancerous tumors. This agent has been safely studied in animals and a limited number of human patients with lung cancer. This study is being done to determine the best dose to use and to fully evaluate the images that result from using this new agent.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Triple Negative Breast | – | Drug: 124I-NM404124I-NM404 in triple negative breast cancer |
| Prostate | – | Drug: 124I-NM404124I-NM404 in prostate cancer |
| Colorectal | – | Drug: 124I-NM404124I-NM404 in colorectal cancer |
| Gastric | – | Drug: 124I-NM404124I-NM404 in gastric cancer |
| Ovarian | – | Drug: 124I-NM404124I-NM404 in ovarian cancer |
| Pancreatic | – | Drug: 124I-NM404124I-NM404 in pancreatic cancer |
| Esophageal | – | Drug: 124I-NM404124I-NM404 in esophageal cancer |
| Sarcoma | – | Drug: 124I-NM404124I-NM404 in soft tissue sarcoma |
| Head & Neck | – | Drug: 124I-NM404124I-NM404 in head and neck cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be referred to the Phase I oncology research office by their treating oncologist. Outside referrals will be managed by Cancer Connect who will ensure that potential subjects are first evaluated by a UW medical oncologist in the cancer clinic who will then refer them, if appropriate, to the Phase I oncology office.
Key inclusion criteria (6 listed)
- Diagnosis of advanced solid malignancy.
- Allowed tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head \& neck cancer
- Disease must be at least 1cm in diameter
- Brain metastasis must be stable for at least one month.
- ECOG performance status 0-2
Key exclusion criteria (5 listed)
- Skin lesions only
- Chemotherapy or radiotherapy within 1 week
- Residual toxicities of grade 2 or greater from prior therapy
- Adequate organ function as per specified laboratory parameter
- Platelet count > or = to 75,000/uL
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 |
|---|---|---|
| 124I-NM404124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi. | Drug | Colorectal, Esophageal, Gastric, Head & Neck, Ovarian, Pancreatic, Prostate, Sarcoma, Triple Negative Breast |
Primary outcome
Optimal Imaging Parameters
Time frame: 2 years
To determine the optimal imaging parameters (dose, acquisition time, imaging time post injection, normal organ and tumor dosimetry) of 124I-NM404 in subjects with advanced solid malignancies with one of the following tumor types: triple negative breast, prostate, colorectal, gastric, ovarian, pancreatic, esophageal, soft tissue sarcoma, and head \& neck cancer
2 secondary outcomes
Adverse events
Time frame: 2 years
PET comparison
Time frame: 2 years
Results and safety
The study was stopped early (reason given: Sponsor determined this trial does not support their anticipated clinical development program.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2019.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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.
Glenn Liu, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Triple Negative Breast, Prostate, Colorectal, Gastric, Ovarian, Pancreatic, Esophageal, Soft Tissue Sarcoma, and Head & Neck Cancer, run by University of Wisconsin, Madison 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 6 inclusion and 5 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 21 Nov 2019. 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.
Are results available for this study?
The study was stopped early (reason given: Sponsor determined this trial does not support their anticipated clinical development program.). Results are not available in the source record.
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?
Optimal Imaging Parameters (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Nov 2019; AzTrials last refreshed its copy on 30 Oct 2026.