CancerPhase 1NCT00263783
Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors
A Phase 1 study testing MEDI-522 in people with Cancer, run by MedImmune LLC at 1 site in France.
Trial summary
To determine the safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Cancer
- What is being tested?
- MEDI-522
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2001to Jun 2002
- 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 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or post menopausal female patients with histologically confirmed advanced refractory solid tumors for which no reasonable therapy exists. Patient is not required to have measurable disease.
- Age >18 years
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see APPENDIX 1 for details).
- Patients who had prior surgery, radiation, or chemotherapy will be eligible provided at least 4 weeks have elapsed prior to study initiation. Patients must have recovered from treatment-related toxicities, and surgical wounds must be healed.
- Patients who have had prior immunotherapy with approved agents are eligible.
- Patients must have hemoglobin >10.0 g/dL, ANC >1,000/mm3, WBC >3,000/mm3,000/mm3, platelets ³100,000/mm3, bilirubin £2.0 mg/dL, AST/ALT no greater than 5 times the upper limit of normal (ULN), and serum creatinine <1.5 mg/dL (or calculated creatinine clearance ³60 mL/min).
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- Patients must have prothrombin time (PT) and partial thromboplatin time (PTT) less than upper limit of normal or international normalized ratio (INR) less than 1.1.
- Patients must have thyroxine (T4) and thyroid-stimulating hormone (TSH) within normal limits.
- Patients must be informed of and understand the investigational nature of this trial and give written informed consent prior to receipt of any study medication or beginning study procedures.
Who cannot join
- Patient has known brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis.
- Patient has respiratory insufficiency requiring oxygen treatment, or has lymphangitic involvement of lungs.
- Patient has evidence of hematemesis, melena, hematochezia, or hematuria (2 or greater on urine dipstick).
- Patient has a history of a significant adverse event related to previously administered humanized monoclonal antibody.
- Patient has known HIV or hepatitis virus infection.
- Patient has prior myocardial infarction or angina, or uncontrolled hypertension (systolic BP >140 mm Hg).
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- Patient has either prior strokes or transient ischemic attacks.
- Patient has active infections requiring systemic antiinfective therapy or other physical or psychological illnesses that would preclude drug administration or patient compliance.
- Patient has donated blood or received an investigational agent in the last 4 weeks.
- Patient has a history of active illness or behavior, including substance dependence or abuse that, in the opinion of the investigator, might pose additional risk in administering the study drug to the patient.
- General medical or psychological conditions that would not permit the patient to complete the study or sign the informed consent
Trial locations and contacts
1 site in 1 country.
About this study
To determine the safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors.
- Conditions
- Cancer
- Being tested
- MEDI-522
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-522Drug
MEDI-522 will be administered at doses of 1.0, 2.0, 4.0, 6.0, 8.0, and 10.0 mg/kg. [As a 30 minute IV infusion initially as a single dose (single-dose treatment period) and 2 to 5 weeks later as weekly doses (multiple-dose treatment period) for up to 1 year.]
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-522 Receives: Drug: MEDI-522 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: The incidence and severity of adverse experiences and laboratory abnormalities will be tabulated and presented overall and by dose.
Measured: Study Day 1 up to 8 weeks
Secondary outcomes (3)
Pharmacokinetics: Will be assessed using the variables of area under the concentration curve (AUC) which will be calculated by the trapezoidal rule, peak concentration (Cmax), time to peak concentration (Tmax), half life
Measured: 35 days after the first dose
Measured pharmacokinetic parameters may be one of the factors used in determination of the Phase II regimen.
Measured: Appx. 5 days after the 4th weekly dose
Antitumor Activity: The antitumor activity of MEDI-522 in patients with refractory solid tumors will be assessed by calculating tumor response rate and time to disease progression.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2005 (estimated)
- Study startMar 2001
- Primary completionApr 2002
- Study completionJun 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Luz Hammershaimb, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263783
- Sponsor's protocol ID
- MI-CP065
- Status last verified
- Jan 2009
- First submitted
- 8 Dec 2005
- Last updated
- 29 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Trial of Weekly MEDI-522 in Patients With Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT00263783
- Acronym / sponsor ID
- MI-CP065
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2001
- Primary completion
- Apr 2002 (actual)
- Study completion
- Jun 2002 (actual)
- First posted
- 9 Dec 2005 (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 safety profile of single and multiple doses of MEDI522 in patients with refractory solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-522MEDI-522 |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or post menopausal female patients with histologically confirmed advanced refractory solid tumors for which no reasonable therapy exists. Patient is not required to have measurable disease.
- Age >18 years
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (see APPENDIX 1 for details).
- Patients who had prior surgery, radiation, or chemotherapy will be eligible provided at least 4 weeks have elapsed prior to study initiation. Patients must have recovered from treatment-related toxicities, and surgical wounds must be healed.
- Patients who have had prior immunotherapy with approved agents are eligible.
Key exclusion criteria (11 listed)
- Patient has known brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis.
- Patient has respiratory insufficiency requiring oxygen treatment, or has lymphangitic involvement of lungs.
- Patient has evidence of hematemesis, melena, hematochezia, or hematuria (2 or greater on urine dipstick).
- Patient has a history of a significant adverse event related to previously administered humanized monoclonal antibody.
- Patient has known HIV or hepatitis virus infection.
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-522MEDI-522 will be administered at doses of 1.0, 2.0, 4.0, 6.0, 8.0, and 10.0 mg/kg. [As a 30 minute IV infusion initially as a single dose (single-dose treatment period) and 2 to 5 weeks later as weekly doses (multiple-dose treatment period) for up to 1 year.] | Drug | 1 |
Primary outcome
Safety: The incidence and severity of adverse experiences and laboratory abnormalities will be tabulated and presented overall and by dose.
Time frame: Study Day 1 up to 8 weeks
3 secondary outcomes
Pharmacokinetics: Will be assessed using the variables of area under the concentration curve (AUC) which will be calculated by the trapezoidal rule, peak concentration (Cmax), time to peak concentration (Tmax), half life
Time frame: 35 days after the first dose
Measured pharmacokinetic parameters may be one of the factors used in determination of the Phase II regimen.
Time frame: Appx. 5 days after the 4th weekly dose
Antitumor Activity: The antitumor activity of MEDI-522 in patients with refractory solid tumors will be assessed by calculating tumor response rate and time to disease progression.
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 29 Jan 2009.
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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.
Luz Hammershaimb, MD study director
MedImmune LLC
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 MEDI-522 in people with Cancer, run by MedImmune LLC at 1 site in France.
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 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: finished, as of the sponsor's last update on 29 Jan 2009. 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 France. 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?
Safety: The incidence and severity of adverse experiences and laboratory abnormalities will be tabulated and presented overall and by dose. (time frame: Study Day 1 up to 8 weeks). 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 29 Jan 2009.