- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02056015
A Phase I Study of MLN6907 in Patients With Metastatic Colorectal
3. januar 2017 opdateret af: Millennium Pharmaceuticals, Inc.
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
20
Fase
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Iowa
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Iowa City, Iowa, Forenede Stater
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New Mexico
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Albuquerque, New Mexico, Mexico
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria
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.
- 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.
Exclusion Criteria
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.
- 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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Diagnostisk
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: [68Ga]MLN6907
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IV Administration of [68Ga]MLN6907 on Day 1
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
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Adverse events (AEs), serious AEs (SAEs), assessments of clinical laboratory values, and vital sign measurements
Tidsramme: Duration of study up to 26 months
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Duration of study up to 26 months
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Human organ and whole body absorbed dose values from organ kinetic quantification of [68Ga]MLN6907 uptake and clearance
Tidsramme: Day 1
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Day 1
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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
Tidsramme: Duration of study up to 26 months
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Duration of study up to 26 months
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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
Tidsramme: Duration of study up to 26 months
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Duration of study up to 26 months
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Plasma [68Ga]MLN6907 and MLN6907 drug substance precursor PK parameters and quantification of GCC levels in liver metastases
Tidsramme: Day 1
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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).
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Day 1
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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
Tidsramme: Duration of study up to 26 months
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Duration of study up to 26 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juni 2015
Primær færdiggørelse (Faktiske)
1. september 2015
Studieafslutning (Faktiske)
1. september 2015
Datoer for studieregistrering
Først indsendt
4. februar 2014
Først indsendt, der opfyldte QC-kriterier
4. februar 2014
Først opslået (Skøn)
5. februar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
5. januar 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. januar 2017
Sidst verificeret
1. januar 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- C35001
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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