Imaging of Solid Gastrointestinal TumorsPhase 1NCT02056015
A Phase I Study of MLN6907 in Patients With Metastatic Colorectal
A Phase 1 study testing [68Ga]MLN6907 in people with Imaging of Solid Gastrointestinal Tumors, run by Millennium Pharmaceuticals, Inc. at 2 sites in 2 countries.
Trial summary
This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of [68Ga]MLN6907 after a single intravenous (IV) administration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Imaging of Solid Gastrointestinal Tumors
- What is being tested?
- [68Ga]MLN6907
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2015to Sep 2015
- Phase
- Phase 1
- 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
Who may be able to join
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Male or female patients 18 years or older.
- Must be diagnosed with colorectal cancer (CRC) with liver metastasis and eligible and scheduled for resection of liver metastases as part of their standard of care treatment plan. The planned surgery must occur greater than 14 days after the day of imaging.
- Patients must consent to provide the sponsor with tumor tissue samples from their resected liver metastases.
- Easter Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Female patients who are post menopausal, surgically sterile, or agree to practice effective methods of contraception from the time of signing the informed consent form through 60 days after the dose of [68Ga]MLN6907 or agree to practice true abstinence.
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- Male patients who agree to practice effective barrier contraception during the entire study treatment period and through 4 months after the dose of [68Ga]MLN6907 or agree to practice true abstinence.
- Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
- Suitable venous access for the study-required, blood sampling (ie, including PK sampling)
- Adequate hepatic function as defined in the protocol.
- Adequate renal function as defined in the protocol.
- Hemoglobin ≥ 9 g/dL.
- Recovery from all adverse effects from prior antitumor therapy to at least Common Terminology Criteria for Adverse Events (CTCAE) (V4.03) Grade 1.
Who cannot join
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before the first dose of [68Ga]MLN6907.
- Any serious medical or psychiatric illness, condition, or personal circumstance, including severe claustrophobia, severe dyspnea, severe back pain, etc., that, in the judgment of the investigator or project clinician, might potentially interfere with the procedures required in this study.
- Involvement in an investigative radioactive or other research procedure within 4 weeks prior to administration of [68Ga]MLN6907.
- Major surgery within 14 days prior to administration of [68Ga]MLN6907 5. Serious infection (viral, bacterial, or fungal) within 14 days before administration of [68Ga]MLN6907 or evidence of active infection during screening.
- Life-threatening illness unrelated to cancer.
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- Clinically significant central nervous system (CNS) metastases.
- Known inflammatory bowel disease.
- Known hepatitis B surface antigen-positive or known or suspected active hepatitis C infection (testing not required).
- History of any hypersensitivity to any component of [68Ga]MLN6907.
- Symptomatic cardiac disease, including ventricular dysfunction, coronary artery disease, or arrhythmias, if this would, in the opinion of the investigator or project clinician, interfere with assessment of efficacy or safety of [68Ga]MLN6907.
- Admission or evidence of addictive disorders (eg, illicit drug use, drug abuse, or alcohol abuse) that would limit compliance with study requirements.
- Inability to lie flat for the duration of image acquisition.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Phase 1, First-in-Human, Single-Dose, Open-Label, Positron Emission Tomography (PET) Imaging Study of [68Ga]MLN6907 in Patients With Metastatic Colorectal Carcinoma.
This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of [68Ga]MLN6907 after a single intravenous (IV) administration. Patients with Metastatic Colorectal Carcinoma who are scheduled for resection of liver metastases as part of their treatment plan will be eligible for enrollment.
- Conditions
- Imaging of Solid Gastrointestinal Tumors
- Being tested
- [68Ga]MLN6907
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68Ga]MLN6907Drug
IV Administration of [68Ga]MLN6907 on Day 1
| Study group | Role | What they receive |
|---|---|---|
| [68Ga]MLN6907 | Experimental | Not described Receives: Drug: [68Ga]MLN6907 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs), serious AEs (SAEs), assessments of clinical laboratory values, and vital sign measurements
Measured: Duration of study up to 26 months
Human organ and whole body absorbed dose values from organ kinetic quantification of [68Ga]MLN6907 uptake and clearance
Measured: Day 1
Secondary outcomes (4)
Expert visual rating of [68Ga]MLN6907 liver tumor uptake and quantitative measurement of tumor-to-background (normal liver, muscle, etc.) ratio for each liver tumor
Measured: Duration of study up to 26 months
Time-activity curves for each liver tumor region of interest (ROI) and kinetic curves of the ratio of each liver tumor to background (including for normal liver, muscle, and blood); determination of the time for the maximum ratio for each tumor lesion
Measured: Duration of study up to 26 months
Plasma [68Ga]MLN6907 and MLN6907 drug substance precursor PK parameters and quantification of GCC levels in liver metastases
PK parameters include single-dose maximum (peak) concentration (Cmax), single-dose time to reach maximum (peak) concentration (Tmax), terminal disposition half-life (t1/2), and area under the plasma concentration versus time curve (AUC).
Measured: Day 1
Correlate tumor uptake of [68Ga]MLN6907 measured by PET and the level of guanylyl cyclase C (GCC) expression in tumor lesions from surgical specimens , for tumors in individual patients and for aggregated liver tumors across patients
Measured: Duration of study up to 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Imaging of Solid Gastrointestinal TumorsStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Millennium Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Millennium Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056015
- Sponsor's protocol ID
- C35001
- Status last verified
- Jan 2017
- First submitted
- 4 Feb 2014
- Last updated
- 5 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, First-in-Human, Single-Dose, Open-Label, Positron Emission Tomography (PET) Imaging Study of [68Ga]MLN6907 in Patients With Metastatic Colorectal Carcinoma.
- ClinicalTrials.gov ID
- NCT02056015
- Acronym / sponsor ID
- C35001
- Conditions
- Imaging of Solid Gastrointestinal Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Millennium Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Feb 2014 (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.
This study is a first-in-human (FIH), single-dose, open-label, phase 1 study designed to assess the safety, pharmacokinetics (PK), distribution, and radiation dosimetry of [68Ga]MLN6907 after a single intravenous (IV) administration. Patients with Metastatic Colorectal Carcinoma who are scheduled for resection of liver metastases as part of their treatment plan will be eligible for enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [68Ga]MLN6907 | Experimental | Drug: [68Ga]MLN6907 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Male or female patients 18 years or older.
- Must be diagnosed with colorectal cancer (CRC) with liver metastasis and eligible and scheduled for resection of liver metastases as part of their standard of care treatment plan. The planned surgery must occur greater than 14 days after the day of imaging.
- Patients must consent to provide the sponsor with tumor tissue samples from their resected liver metastases.
- Easter Cooperative Oncology Group (ECOG) performance status of 0 to 1.
Key exclusion criteria (13 listed)
- Patients meeting any of the following exclusion criteria are not to be enrolled in the study.
- Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before the first dose of [68Ga]MLN6907.
- Any serious medical or psychiatric illness, condition, or personal circumstance, including severe claustrophobia, severe dyspnea, severe back pain, etc., that, in the judgment of the investigator or project clinician, might potentially interfere with the procedures required in this study.
- Involvement in an investigative radioactive or other research procedure within 4 weeks prior to administration of [68Ga]MLN6907.
- Major surgery within 14 days prior to administration of [68Ga]MLN6907 5. Serious infection (viral, bacterial, or fungal) within 14 days before administration of [68Ga]MLN6907 or evidence of active infection during screening.
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 |
|---|---|---|
| [68Ga]MLN6907IV Administration of [68Ga]MLN6907 on Day 1 | Drug | [68Ga]MLN6907 |
Primary outcome
Adverse events (AEs), serious AEs (SAEs), assessments of clinical laboratory values, and vital sign measurements
Time frame: Duration of study up to 26 months
Human organ and whole body absorbed dose values from organ kinetic quantification of [68Ga]MLN6907 uptake and clearance
Time frame: Day 1
4 secondary outcomes
Expert visual rating of [68Ga]MLN6907 liver tumor uptake and quantitative measurement of tumor-to-background (normal liver, muscle, etc.) ratio for each liver tumor
Time frame: Duration of study up to 26 months
Time-activity curves for each liver tumor region of interest (ROI) and kinetic curves of the ratio of each liver tumor to background (including for normal liver, muscle, and blood); determination of the time for the maximum ratio for each tumor lesion
Time frame: Duration of study up to 26 months
Plasma [68Ga]MLN6907 and MLN6907 drug substance precursor PK parameters and quantification of GCC levels in liver metastases
Time frame: Day 1
Correlate tumor uptake of [68Ga]MLN6907 measured by PET and the level of guanylyl cyclase C (GCC) expression in tumor lesions from surgical specimens , for tumors in individual patients and for aggregated liver tumors across patients
Time frame: Duration of study up to 26 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2017.
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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.
Medical Monitor study director
Millennium Pharmaceuticals, Inc.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [68Ga]MLN6907 in people with Imaging of Solid Gastrointestinal Tumors, run by Millennium Pharmaceuticals, Inc. at 2 sites in 2 countries.
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 13 inclusion and 13 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: finished, as of the sponsor's last update on 5 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Mexico. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse events (AEs), serious AEs (SAEs), assessments of clinical laboratory values, and vital sign measurements (time frame: Duration of study up to 26 months). The study lists 2 primary outcomes in all. 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 5 Jan 2017.