CancerPhase 1MEDI-547NCT00796055
Study of MEDI-547 to Evaluate the Safety, Tolerability, and Biologic Activity of IV Administration in Subjects With Relapsed or Refractory Solid Tumors
A Phase 1 study testing MEDI-547 in people with Cancer, run by MedImmune LLC at 2 sites in United States.
Trial summary
To determine the safety, tolerability, and the highest dose of this drug given once every 3 weeks or once every week, (per 21 day cycle) in adult subjects with relapsed or refractory solid tumors. 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-547
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2009to Jun 2010
- 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
- For the dose-escalation cohort: cancer relapsed or refractory to at least 1 prior standard care systemic regimen standard therapy with previous histological confirmation of diagnosis of fallopian tube, primary peritoneal, endometrial, cervical, prostate, non-small cell lung, esophageal, gastric, bladder, and renal cell carcinomas or melanoma. Subjects with relapsed or refractory breast, epithelial ovarian, or colon cancer with previous histological confirmation of diagnosis must have progressed through more than 1 prior regimen of therapy. For patients enrolling at the NCI, pathology must be confirmed by the Department of Pathology, CCR, NCI.
- For the dose-expansion cohort: relapsed or refractory epithelial ovarian cancer with progression through more than 1 prior regimen of therapy, or relapsed or refractory fallopian tube, or primary peritoneal cancer with progression after at least 1 prior standard care systemic regimen, with previous histological confirmation of cancer diagnosis. For patients enrolling at the NCI, pathology must be confirmed by the Department of Pathology, Center for Cancer Research (CCR), NCI.
- Patients with the following histologic epithelial ovarian cancer cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS).
- For the dose-expansion cohort of subjects with relapsed or refractory ovarian cancer, subjects must have an archival tumor sample that demonstrates EphA2 expression by immunohistochemical stain.
- Males or females at least 18 years of age at the time of obtaining informed consent.
- Women of childbearing potential must have a negative serum pregnancy test within 72 hours prior to MEDI-547 administration; and men and women of reproductive potential must agree to practice an effective method of avoiding pregnancy (this is not to include oral or implanted contraceptives (such as the "pill", the "patch", a Depo Provera shot, or hormone laced intrauterine device, but allows the following: non hormonal (copper), intrauterine device, female condom, diaphragm with spermicide, cervical cap, abstinence, use of a condom by the sexual partner or sterile sexual partner) beginning at the time the ICF is signed, and must agree to continue using such precautions while receiving MEDI-547 through 30 days after the last dose of MEDI-547.
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- For the dose-escalation cohort: measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria is desirable but not required. The following are not considered measurable: pleural effusion or ascites; osteoblastic/osteoclastic lesions or evidence of disease on bone scan alone; progressive irradiated lesions alone, bone marrow involvement, brain metastases, malignant hepatomegaly by physical exam alone; or chemical markers (eg, CA-125, carcinoembryonic antigen [CEA], or prostate specific antigen [PSA]). Recurrent disease following surgery or radiotherapy is measurable provided that 30 days have elapsed since treatment and that measurable disease exists outside the radiation port, or there is clear progression within the radiation port.
- For the dose-expansion cohort: measurable disease, by RECIST criteria is required. The following are not considered measurable: pleural effusion or ascites; osteoblastic/osteoclastic lesions or evidence of disease on bone scan alone; progressive irradiated lesions alone, bone marrow involvement, brain metastases, malignant hepatomegaly by physical exam alone; or chemical markers (eg, CA-125, CEA, or PSA). Recurrent disease following surgery or radiotherapy is measurable provided that 30 days has elapsed since treatment and that measurable disease exists outside the radiation port, or there is clear progression within the radiation port.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
- Life expectancy of greater than 16 weeks.
- For subjects who had prior treatment with chemotherapy, biological therapy, radiotherapy, or investigational therapy or had prior surgery: eligible for study entry if at least 30 days have passed since their treatment/surgery, provided that all toxicities related to prior treatment have resolved to ≤ Grade 1 severity by National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0 and all surgical wounds have healed.
- Prior immunotherapy with approved agents (eg, trastuzumab, cetuximab, panitumumab, bevacizumab) is allowable if at least 30 days have passed.
- Absolute neutrophil count (ANC) ³ 1500/mm3, platelets ³ 100,000/mm3, hemoglobin > 10.0 g/dL, serum creatinine greater than or equal to 1.5 times the upper limit of normal [ULN] or calculated creatinine clearance > 50 mL/min, serum bilirubin greater than or equal to 2 times the ULN, alkaline phosphatase < 3 times the ULN, and aspartate transferase (AST) and alanine transferase (ALT) greater than or equal to 3 times the ULN.
- Prothrombin time (PT), partial thromboplastin time (PTT), and international normalized ratio (INR) that are within normal institutional limits.
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization (applies to covered entities in the USA only) obtained from the subject prior to receipt of any study medication or beginning study procedures.
Who cannot join
- Pregnant or lactating women.
- A history of central nervous system metastases or primary central nervous system tumors.
- Symptomatic pleural effusion or ascites requiring paracentesis.
- Symptomatic peripheral neuropathy of Grade 2 or greater.
- Respiratory insufficiency requiring oxygen treatment, or lymphangitic involvement of lungs.
- Any evidence of hematemesis, melena, hematochezia, grade 2 or higher hemoptysis, or gross hematuria. Patients with grade 1 hemoptysis or microscopic hematuria will be permitted on study.
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- Active or recent history (within 3 months) of keratitis or conjunctivitis.
- A history of significant adverse events related to a previously administered monoclonal antibody.
- A history of human immunodeficiency virus (HIV) or hepatitis virus infection (HBV,HCV)will be excluded to eliminate the risk of increased adverse events due to immune compromise or liver dysfunction.
- Any evidence or history of myocardial infarction, angina, or arrhythmia (including atrial fibrillation, multifocal premature ventricular contractions, ventricular bigeminy or trigeminy, ventricular tachycardia or requirement for anti-arrhythmics including digoxin), within 6 months prior to initiation of study drug.
- Any evidence of uncontrolled hypertension (systolic blood pressure > 150 mm Hg) within 3 months prior to initiation of investigational product.
- Subjects currently on anticoagulant therapy for thromboembolic disorders or prophylactic reasons will be excluded.
- Any evidence of severe congestive heart failure with severity New York Heart Association classification > Class 1 within the past 12 weeks.
- A marked baseline prolongation of QTc interval (eg, demonstration of QTc interval ≥ 500 millisecs [ms]).
- A prior stroke or transient ischemic attack (TIA) within 6 months prior to initiation of (investigational product) MEDI-547.
- Any evidence of an active infection or systemic use of antimicrobials within 72 hours prior to initial treatment with MEDI-547.
- Current or planned participation (from the day of study entry through 30 days after the last dose of study drug) in a research protocol in which another investigational agent or therapy may be administered.
- Received another investigational agent within 30 days prior to initiation of study drug or not fully recovered from prior investigational treatment.
- A requirement for palliative chemotherapy, hormonal therapy, radiotherapy, surgery, or immunotherapy during the course of the study.
- For subjects in the dose-expansion cohort, history of prior malignancies within the past 5 years other than non-melanomatous skin cancers that have been controlled, carcinoma in situ of the cervix, or superficial bladder cancer.
- A general medical or psychological condition or behavior, including substance dependence or abuse that, in the opinion of the investigator, might not permit the subject to complete the study or sign the informed consent.
- Any condition that in the opinion of the investigator would interfere with evaluation of the investigational product or interpretation of study results.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Site
Bethesda, Maryland, 20892
Research Site
Detroit, Michigan, 48201
About this study
Official title: A Phase 1, Open-Label Study of MEDI-547 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Biologic Activity of Intravenous Administration in Subjects With Relapsed or Refractory Solid Tumors Associated With EphA2 Expression
To determine the safety, tolerability, and the highest dose of this drug given once every 3 weeks or once every week, (per 21 day cycle) in adult subjects with relapsed or refractory solid tumors.
Read the detailed description
To determine the safety, tolerability, and maximum tolerated dose (MTD) of MEDI 547 in a dose escalation cohort for either administration schedule 1 dose every 3 weeks or 1 dose every week in adult subjects with relapsed or refractory solid tumors.
- Conditions
- Cancer
- Being tested
- MEDI-547
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-547Drug
Administered at a dose and schedule as determined by the subject's enrollment cohort as a 60 minute IV infusion as part of a 21-day treatment cycle.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | MEDI-547 Receives: Drug: MEDI-547 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of MEDI-547 will be assessed based on the incidence of AEs, SAEs, laboratory abnormalities, physical examination changes, toxicities leading to permanent discontinuation of MEDI-547 and MEDI-547-related deaths.
Measured: 30 days after the last dose of MEDI-547.
Secondary outcomes (1)
The antitumor activity of MED-547 will be assessed based on objective response rate (ORR), time to response (TTR), duration of response (DR), time to progression (TTP), progression-free survival (PFS), and overall survival (OS).
Measured: 30 days after the last dose of MEDI-547
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startAug 2009
- Primary completionFeb 2010
- Study completionJun 2010
Why it stopped: MI-CP177 study closed per sponsor decision.
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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sherry Warwick, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796055
- Sponsor's protocol ID
- MI-CP177
- Acronym
- MEDI-547
- Status last verified
- Nov 2011
- First submitted
- 20 Nov 2008
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study of MEDI-547 to Evaluate the Safety, Tolerability, Pharmacokinetics, and Biologic Activity of Intravenous Administration in Subjects With Relapsed or Refractory Solid Tumors Associated With EphA2 Expression
- ClinicalTrials.gov ID
- NCT00796055
- Acronym / sponsor ID
- MEDI-547 / MI-CP177
- Conditions
- Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: MI-CP177 study closed per sponsor decision.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Nov 2008 (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, tolerability, and the highest dose of this drug given once every 3 weeks or once every week, (per 21 day cycle) in adult subjects with relapsed or refractory solid tumors.
Detailed description
To determine the safety, tolerability, and maximum tolerated dose (MTD) of MEDI 547 in a dose escalation cohort for either administration schedule 1 dose every 3 weeks or 1 dose every week in adult subjects with relapsed or refractory solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MEDI-547MEDI-547 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- For the dose-escalation cohort: cancer relapsed or refractory to at least 1 prior standard care systemic regimen standard therapy with previous histological confirmation of diagnosis of fallopian tube, primary peritoneal, endometrial, cervical, prostate, non-small cell lung, esophageal, gastric, bladder, and renal cell carcinomas or melanoma. Subjects with relapsed or refractory breast, epithelial ovarian, or colon cancer with previous histological confirmation of diagnosis must have progressed through more than 1 prior regimen of therapy. For patients enrolling at the NCI, pathology must be confirmed by the Department of Pathology, CCR, NCI.
- For the dose-expansion cohort: relapsed or refractory epithelial ovarian cancer with progression through more than 1 prior regimen of therapy, or relapsed or refractory fallopian tube, or primary peritoneal cancer with progression after at least 1 prior standard care systemic regimen, with previous histological confirmation of cancer diagnosis. For patients enrolling at the NCI, pathology must be confirmed by the Department of Pathology, Center for Cancer Research (CCR), NCI.
- Patients with the following histologic epithelial ovarian cancer cell types are eligible: Serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell carcinoma, malignant Brenner's Tumor, or adenocarcinoma not otherwise specified (NOS).
- For the dose-expansion cohort of subjects with relapsed or refractory ovarian cancer, subjects must have an archival tumor sample that demonstrates EphA2 expression by immunohistochemical stain.
- Males or females at least 18 years of age at the time of obtaining informed consent.
Key exclusion criteria (22 listed)
- Pregnant or lactating women.
- A history of central nervous system metastases or primary central nervous system tumors.
- Symptomatic pleural effusion or ascites requiring paracentesis.
- Symptomatic peripheral neuropathy of Grade 2 or greater.
- Respiratory insufficiency requiring oxygen treatment, or lymphangitic involvement of lungs.
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-547Administered at a dose and schedule as determined by the subject's enrollment cohort as a 60 minute IV infusion as part of a 21-day treatment cycle. | Drug | 1 |
Primary outcome
Safety and tolerability of MEDI-547 will be assessed based on the incidence of AEs, SAEs, laboratory abnormalities, physical examination changes, toxicities leading to permanent discontinuation of MEDI-547 and MEDI-547-related deaths.
Time frame: 30 days after the last dose of MEDI-547.
1 secondary outcome
The antitumor activity of MED-547 will be assessed based on objective response rate (ORR), time to response (TTR), duration of response (DR), time to progression (TTP), progression-free survival (PFS), and overall survival (OS).
Time frame: 30 days after the last dose of MEDI-547
Results and safety
The study was stopped early (reason given: MI-CP177 study closed per sponsor decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2011.
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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.
Sherry Warwick study director
MedImmune LLC
2 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-547 in people with Cancer, run by MedImmune LLC at 2 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 15 inclusion and 22 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: stopped early, as of the sponsor's last update on 17 Nov 2011. 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. 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 was stopped early (reason given: MI-CP177 study closed per sponsor decision.). Results are not available in the source record.
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 and tolerability of MEDI-547 will be assessed based on the incidence of AEs, SAEs, laboratory abnormalities, physical examination changes, toxicities leading to permanent discontinuation of MEDI-547 and MEDI-547-related deaths. (time frame: 30 days after the last dose of MEDI-547.). 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 17 Nov 2011.