CancerPhase 1/2NCT00284817
Phase I Study of MEDI522 in Patients With Irinotecan-Refractory Advanced Colorectal Cancer
A Phase 1/2 study testing MEDI-522 in people with Cancer, run by MedImmune LLC at 1 site in United States.
Trial summary
Assess the safety and tolerance of a weekly MEDI522 regimen in patients with irinotecan-refractory advanced CRC or other solid tumors refractory to standard therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to May 2005
- Phase
- Phase 1/2
- 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
- Patients must have histologically-confirmed advanced CRC that has progressed through an irinotecan-containing regimen for metastatic disease, or has recurred during, or within 6 months of completing, an irinotecan-containing adjuvant regimen, or other histologically-confirmed solid tumors refractory to standard therapy.
- Age at least 18 years at the time of the first dose of study drug.
- Both males and females are eligible. Sexually active females, unless surgically sterile (or at least one year post-menopausal), must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of study drug, and must agree to continue using such precautions for 30 days after the final dose of study drug. Sexually active females of reproductive potential must have a negative serum b human chorionic gonadotropin (bhCG) pregnancy test within 3 days of start of therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. ECOG criteria are described in Appendix A.
- Patients who had prior treatment with chemotherapy or radiotherapy or had prior surgery are eligible for study entry if at least 4 weeks have past since their treatment/surgery.
- All toxicities related to prior treatment must have resolved and all surgical wounds must have healed.
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- Prior immunotherapy with approved agents is allowable.
- ANC ³1500/mm3, platelets ³100,000/mm3, hemoglobin >10.0 g/dL, serum creatinine £1.5 mg/dL or calculated creatinine clearance >50 mL/min, serum bilirubin £2.0 mg/dL, and AST/ALT £5 times the upper limit of normal (ULN).
- PT/PTT less than ULN or international normalized ratio (INR) less than 1.12.
- Thyroxine (T4) and thyroid-stimulating hormone (TSH) within normal limits.
- Written informed consent obtained from the patient prior to receipt of any study medication or beginning study procedures.
Who cannot join
- Pregnancy or nursing.
- Known brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis.
- Respiratory insufficiency requiring oxygen treatment, or lymphangitic involvement of lungs.
- Any evidence of hematemesis, melena, hematochezia, or gross hematuria.
- A history of significant adverse events related to a previously administered humanized monoclonal antibody.
- A known human immunodeficiency virus (HIV) or hepatitis virus infection.
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- A prior myocardial infarction or angina, or uncontrolled hypertension (systolic blood pressure >150 mm Hg).
- A prior stroke or transient ischemic attack.
- An active infection requiring systemic antiinfective therapy.
- Received an investigational agent in the last 4 weeks of initiation of study treatment.
- A requirement for palliative chemotherapy, hormonal therapy, or immunotherapy during the course of the study.
- Clinical evidence of bowel obstruction.
- A history of other malignancies within the past 5 years (with the exception of basal cell carcinoma of the skin or completely excised in situ carcinoma of the cervix).
- A general medical or psychological condition or behavior, including substance dependence or abuse that, in the opinion of the investigator, might not permit the patient to complete the study or sign the informed consent.
- Prior treatment with MEDI-522 or MEDI-523.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
About this study
Official title: Phase I Study of MEDI522, a Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Irinotecan-Refractory Advanced Colorectal Cancer or Other Solid Tumors Refractory to Standard Therapy
- Assess the safety and tolerance of a weekly MEDI522 regimen in patients with irinotecan-refractory advanced CRC or other solid tumors refractory to standard therapy.
Read the detailed description
- Assess the safety and tolerance of a weekly MEDI 522 regimen in patients with irinotecan-refractory advanced CRC.
- Determine a Phase II recommended dose based on acceptable dose-limiting toxicity. Other considerations such as pharmacokinetic parameters may also be factored into the determination of a Phase II dose.
The secondary objectives of the study are to:
- Assess any antitumor activity of MEDI-522 in this patient population.
- 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
Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 1 mg/kg for 51 weeks.
MEDI-522Drug
Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks.
MEDI-522Drug
Administered as a 30-minute IV infusion; 6 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks.
MEDI-522Drug
Administered as a 30-minute IV infusion; on Study Day 0 followed by weekly maintenance doses of 3mg/kg for 51 weeks.
MEDI-522Drug
The next cohort of patients will be treated after at least 3 of 4 patients treated in the previous cohort receive at least 3 weeks of treatment and experience no dose-limiting toxicity (DLT).
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-522 Receives: Drug: MEDI-522 |
| 2 | Experimental | MEDI-522 Receives: Drug: MEDI-522 |
| 3 | Experimental | MEDI-522 Receives: Drug: MEDI-522 |
| 4 | Experimental | MEDI-522 Receives: Drug: MEDI-522 |
| 5 | Experimental | MEDI-522 Receives: Drug: MEDI-522 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The recommended Phase II dose will be based on acceptable dose-limiting toxicity
Measured: Study Days 0, 7, 14, 21, 28, 35, 42, and 49.
Secondary outcomes (1)
Pharmacokinetic parameters may also be factored into the determination of a Phase II dose and; Tumor response
Measured: Study Days 0, 28, 56, 84, 112, 140, 168, 196, 224, 252, 280, 308, 336, 357; and tumor response on Study Days 56, 112, 168, 224, 280, 336, and 387.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2006 (estimated)
- Study startJul 2001
- Primary completionJan 2005
- Study completionMay 2005
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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Krista Arbaugh, Dir., Clinical Ops, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00284817
- Sponsor's protocol ID
- MI-CP068
- Status last verified
- May 2008
- First submitted
- 31 Jan 2006
- Last updated
- 29 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of MEDI522, a Humanized Monoclonal Antibody Directed Against the Human Alpha V Beta 3 Integrin, in Patients With Irinotecan-Refractory Advanced Colorectal Cancer or Other Solid Tumors Refractory to Standard Therapy
- ClinicalTrials.gov ID
- NCT00284817
- Acronym / sponsor ID
- MI-CP068
- Conditions
- Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Jul 2001
- Primary completion
- Jan 2005 (actual)
- Study completion
- May 2005 (actual)
- First posted
- 1 Feb 2006 (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.
- Assess the safety and tolerance of a weekly MEDI522 regimen in patients with irinotecan-refractory advanced CRC or other solid tumors refractory to standard therapy.
Detailed description
- Assess the safety and tolerance of a weekly MEDI 522 regimen in patients with irinotecan-refractory advanced CRC.
- Determine a Phase II recommended dose based on acceptable dose-limiting toxicity. Other considerations such as pharmacokinetic parameters may also be factored into the determination of a Phase II dose.
The secondary objectives of the study are to:
- Assess any antitumor activity of MEDI-522 in this patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-522MEDI-522 |
| 2 | Experimental | Drug: MEDI-522MEDI-522 |
| 3 | Experimental | Drug: MEDI-522MEDI-522 |
| 4 | Experimental | Drug: MEDI-522MEDI-522 |
| 5 | Experimental | Drug: MEDI-522MEDI-522 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients must have histologically-confirmed advanced CRC that has progressed through an irinotecan-containing regimen for metastatic disease, or has recurred during, or within 6 months of completing, an irinotecan-containing adjuvant regimen, or other histologically-confirmed solid tumors refractory to standard therapy.
- Age at least 18 years at the time of the first dose of study drug.
- Both males and females are eligible. Sexually active females, unless surgically sterile (or at least one year post-menopausal), must have used an effective method of avoiding pregnancy (including oral or implanted contraceptives, IUD, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of study drug, and must agree to continue using such precautions for 30 days after the final dose of study drug. Sexually active females of reproductive potential must have a negative serum b human chorionic gonadotropin (bhCG) pregnancy test within 3 days of start of therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. ECOG criteria are described in Appendix A.
- Patients who had prior treatment with chemotherapy or radiotherapy or had prior surgery are eligible for study entry if at least 4 weeks have past since their treatment/surgery.
Key exclusion criteria (15 listed)
- Pregnancy or nursing.
- Known brain metastases or primary brain tumors, symptomatic pleural effusion or ascites requiring paracentesis.
- Respiratory insufficiency requiring oxygen treatment, or lymphangitic involvement of lungs.
- Any evidence of hematemesis, melena, hematochezia, or gross hematuria.
- A history of significant adverse events related to a previously administered humanized monoclonal antibody.
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-522Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 1 mg/kg for 51 weeks. | Drug | 1 |
| MEDI-522Administered as a 30-minute IV infusion; 4 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks. | Drug | 2 |
| MEDI-522Administered as a 30-minute IV infusion; 6 mg/kg on Study Day 0 followed by weekly maintenance doses of 2mg/kg for 51 weeks. | Drug | 3 |
| MEDI-522Administered as a 30-minute IV infusion; on Study Day 0 followed by weekly maintenance doses of 3mg/kg for 51 weeks. | Drug | 4 |
| MEDI-522The next cohort of patients will be treated after at least 3 of 4 patients treated in the previous cohort receive at least 3 weeks of treatment and experience no dose-limiting toxicity (DLT). | Drug | 5 |
Primary outcome
The recommended Phase II dose will be based on acceptable dose-limiting toxicity
Time frame: Study Days 0, 7, 14, 21, 28, 35, 42, and 49.
1 secondary outcome
Pharmacokinetic parameters may also be factored into the determination of a Phase II dose and; Tumor response
Time frame: Study Days 0, 28, 56, 84, 112, 140, 168, 196, 224, 252, 280, 308, 336, 357; and tumor response on Study Days 56, 112, 168, 224, 280, 336, and 387.
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 May 2008.
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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.
Krista Arbaugh, Dir., Clinical Ops 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 1/2 study testing MEDI-522 in people with Cancer, run by MedImmune LLC 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 11 inclusion and 15 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 May 2008. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The recommended Phase II dose will be based on acceptable dose-limiting toxicity (time frame: Study Days 0, 7, 14, 21, 28, 35, 42, and 49.). 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 May 2008.