Gastrointestinal AdenocarcinomasPhase 1NCT01284231
A Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal Adenocarcinomas
A Phase 1 study testing MEDI-565 in people with Gastrointestinal Adenocarcinomas, run by MedImmune LLC at 4 sites in United States.
Trial summary
To determine the maximum tolerated dose and/or optimum biologic dose of MEDI-565 in adult subjects and evaluate the safety profile in adult subjects with advanced gastrointestinal adenocarcinomas who have no available standard or curative treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Adenocarcinomas
- What is being tested?
- MEDI-565
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2010to Jan 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
- Age ≥ 18 years of age at the time of screening
- Adequate contraception from screening through end of trial
- For the dose-escalation phase, subjects with GI adenocarcinomas with no available standard or curative treatments
- Adequate hematological function
- Adequate organ function
- For subjects who had prior treatment with chemotherapy, biological therapy, radiotherapy, or had prior surgery: eligible for study entry if at least 30 days have passed since their treatment/surgery
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- Life expectancy of at least 3 months
- Karnofsky performance status ≥ 70%
- Body weight ≥ 45 kg
Who cannot join
- Concurrent enrollment in another clinical study
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
- Prior treatment with MEDI-565
- History of allergy or reaction to any component of the MEDI-565 formulation
- History of malignancy other than GI adenocarcinoma, within 5 years prior to study entry, with the exception of ductal carcinoma in situ of the breast, basal cell carcinoma of the skin or carcinoma in situ of the cervix successfully treated with curative therapy
- Diagnosis of hepatocellular carcinoma
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- Clinical history of significant CNS pathology
- Active bacterial infection or known bacteremia.
- Vaccination within 2 weeks prior to initiation of MEDI-565
- Infection with HIV-1 or HIV-2; chronic infection with hepatitis B or C
- History of primary immunodeficiency
- History of chronic autoimmune disease
- Elective surgery planned during the study period through 30 days after discontinuation of MEDI-565.
- Treatment with any chemotherapy, radiotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment within 30 days prior to study entry and not recovered from treatment
- Treatment with any investigational agent within 30 days prior to initiation of MEDI-565
- Regular dose of systemic corticosteroids during the 30 days prior to initiation of MEDI-565 or anticipated need of corticosteroids exceeding prednisone 40 mg/day of prednisone or equivalent during the trial, or any other systemic immunosuppressive therapy within 30 days prior to study entry (some maintenance doses allowed)
- Contraindication to any protocol-specified concomitant medications administered during this study
- Pregnancy or lactation
- Evidence of any uncontrolled systemic disease (other than GI adenocarcinoma)
- Recent history of cardiac disease, including myocardial infarction, unstable angina pectoris or uncontrolled arrhythmia within 6 months, or evidence of severe congestive heart failure
- A marked baseline prolongation of corrected QT interval interval
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Research Site
Augusta, Georgia
Research Site
Durham, North Carolina
Research Site
Philadelphia, Pennsylvania
Research Site
Washington D.C., District of Columbia
About this study
Official title: A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal Adenocarcinomas
To determine the maximum tolerated dose and/or optimum biologic dose of MEDI-565 in adult subjects and evaluate the safety profile in adult subjects with advanced gastrointestinal adenocarcinomas who have no available standard or curative treatments.
Read the detailed description
This is a FTIH, dose-escalation and expansion Phase 1 study. The first part is a multicenter, open-label, single-arm, dose-escalation study of MEDI-565 to determine the MTD or OBD and evaluate the safety, tolerability, PK, IM, and antitumor activity of MEDI 565 in adult subjects who have GI adenocarcinomas for which no standard or curative treatments are available. The second part is a dose-expansion study at the MTD or OBD in subjects with selected tumor types.
- Conditions
- Gastrointestinal Adenocarcinomas
- Being tested
- MEDI-565
- Keywords
- MEDI-565, gastrointestinal adenocarcinomas, carcinoembryonic antigen, bispecific T-cell engager
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-565Drug
MEDI-565 will be administered by IV infusion
MEDI-565Drug
20 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.
MEDI-565Drug
20 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.
MEDI-565Drug
20 Subjects with refractory Gastroesophageal cancer to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.
| Study group | Role | What they receive |
|---|---|---|
| MEDI-565 - Dose Escalation | Experimental | Up to 15 dose-escalation cohorts will be enrolled Receives: Drug: MEDI-565 |
| MEDI-565 Dose Expansion Arm 1 | Experimental | 20 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose Receives: Drug: MEDI-565 |
| MEDI-565 Dose Expansion Arm 2 | Experimental | 20 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose Receives: Drug: MEDI-565 |
| MEDI-565 Dose Expansion Arm 3 | Experimental | Subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biological dose Receives: Drug: MEDI-565 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the maximum tolerable dose (MTD) or optimal biological dose (OBD) of MEDI-565 in subjects with gastrointestinal (GI) adenocarcinomas for which no standard or curative treatments are available.
MTD/OBD will be determined based on Dose Limiting Toxicities that will be evaluated from the time of first administration of MEDI-565 through the first 28-day cycle
Measured: MTD/OBD will be evaluated from the time of first administration of MEDI-565 through the first 28-day cycle
Evaluate the safety profile in adult subjects with advanced gastrointestinal (GI) adenocarcinomas who have no available standard or curative treatments.
The number (percentage) of subjects with AEs and SAEs reported through 30 days after the last dose of MEDI 565 will be summarized for all subjects who received at least one dose of study drug (Safety Population).
Measured: AEs and SAEs will be reported through 30 days after the last dose of MEDI 565
Secondary outcomes (3)
Assess the safety and antitumor activity of MEDI-565 in the dose-expansion phase.
The antitumor activity of MED-565 will be assessed using objective response rate (ORR), time to response (TTR), duration of response (DR), time to progression (TTP), progression-free survival (PFS), and overall survival (OS) using RECIST guidelines
Measured: 3 years
Pharmacokinetics of MEDI-565
Individual MEDI-565 concentrations will be tabulated by dose cohort along with descriptive statistics. Noncompartmental PK data analysis will be performed for data obtained from each dose cohort with scheduled PK sample collection. If the data allow, descriptive statistics of noncompartmental PK parameters (AUC, Cmax, Tmax, CL, Vd, t½) will be provided.
Measured: 3 years
Immunogenicity of MED-565
The immunogenic potential of MEDI-565 will be assessed by summarizing the number and percentage of subjects who develop detectable anti-drug antibodies.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal AdenocarcinomasStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer McDevitt, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01284231
- Sponsor's protocol ID
- MI-CP216
- Status last verified
- Mar 2015
- First submitted
- 18 Jan 2011
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study to Evaluate the Safety and Tolerability of MEDI-565 in Adults With Gastrointestinal Adenocarcinomas
- ClinicalTrials.gov ID
- NCT01284231
- Acronym / sponsor ID
- MI-CP216
- Conditions
- Gastrointestinal Adenocarcinomas
- Keywords
- MEDI-565, gastrointestinal adenocarcinomas, carcinoembryonic antigen, bispecific T-cell engager
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 26 Jan 2011 (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.
To determine the maximum tolerated dose and/or optimum biologic dose of MEDI-565 in adult subjects and evaluate the safety profile in adult subjects with advanced gastrointestinal adenocarcinomas who have no available standard or curative treatments.
Detailed description
This is a FTIH, dose-escalation and expansion Phase 1 study. The first part is a multicenter, open-label, single-arm, dose-escalation study of MEDI-565 to determine the MTD or OBD and evaluate the safety, tolerability, PK, IM, and antitumor activity of MEDI 565 in adult subjects who have GI adenocarcinomas for which no standard or curative treatments are available. The second part is a dose-expansion study at the MTD or OBD in subjects with selected tumor types.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| MEDI-565 - Dose Escalation | Experimental | Drug: MEDI-565Up to 15 dose-escalation cohorts will be enrolled |
| MEDI-565 Dose Expansion Arm 1 | Experimental | Drug: MEDI-56520 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose |
| MEDI-565 Dose Expansion Arm 2 | Experimental | Drug: MEDI-56520 subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biologic dose |
| MEDI-565 Dose Expansion Arm 3 | Experimental | Drug: MEDI-565Subjects with selected gastrointestinal tumor type will receive MEDI-565 at the maximum tolerated dose or optimum biological dose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years of age at the time of screening
- Adequate contraception from screening through end of trial
- For the dose-escalation phase, subjects with GI adenocarcinomas with no available standard or curative treatments
- Adequate hematological function
- Adequate organ function
Key exclusion criteria (21 listed)
- Concurrent enrollment in another clinical study
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals
- Prior treatment with MEDI-565
- History of allergy or reaction to any component of the MEDI-565 formulation
- History of malignancy other than GI adenocarcinoma, within 5 years prior to study entry, with the exception of ductal carcinoma in situ of the breast, basal cell carcinoma of the skin or carcinoma in situ of the cervix successfully treated with curative therapy
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 |
|---|---|---|
| MEDI-565MEDI-565 will be administered by IV infusion | Drug | MEDI-565 - Dose Escalation |
| MEDI-56520 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days. | Drug | MEDI-565 Dose Expansion Arm 1 |
| MEDI-56520 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days. | Drug | MEDI-565 Dose Expansion Arm 2 |
| MEDI-56520 Subjects with refractory Gastroesophageal cancer to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days. | Drug | MEDI-565 Dose Expansion Arm 3 |
Primary outcome
Determine the maximum tolerable dose (MTD) or optimal biological dose (OBD) of MEDI-565 in subjects with gastrointestinal (GI) adenocarcinomas for which no standard or curative treatments are available.
Time frame: MTD/OBD will be evaluated from the time of first administration of MEDI-565 through the first 28-day cycle
MTD/OBD will be determined based on Dose Limiting Toxicities that will be evaluated from the time of first administration of MEDI-565 through the first 28-day cycle
Evaluate the safety profile in adult subjects with advanced gastrointestinal (GI) adenocarcinomas who have no available standard or curative treatments.
Time frame: AEs and SAEs will be reported through 30 days after the last dose of MEDI 565
The number (percentage) of subjects with AEs and SAEs reported through 30 days after the last dose of MEDI 565 will be summarized for all subjects who received at least one dose of study drug (Safety Population).
3 secondary outcomes
Assess the safety and antitumor activity of MEDI-565 in the dose-expansion phase.
Time frame: 3 years
Pharmacokinetics of MEDI-565
Time frame: 3 years
Immunogenicity of MED-565
Time frame: 3 years
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 3 Mar 2015.
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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.
Jennifer McDevitt study director
MedImmune LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MEDI-565 in people with Gastrointestinal Adenocarcinomas, run by MedImmune LLC at 4 sites 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 9 inclusion and 21 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 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Determine the maximum tolerable dose (MTD) or optimal biological dose (OBD) of MEDI-565 in subjects with gastrointestinal (GI) adenocarcinomas for which no standard or curative treatments are available. (time frame: MTD/OBD will be evaluated from the time of first administration of MEDI-565 through the first 28-day cycle). 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 3 Mar 2015.