Advanced Solid MalignanciesPhase 1NCT01102400
A Study of MEDI-575 in Patients With Advanced Solid Malignancies
A Phase 1 study testing MEDI-575 in people with Advanced Solid Malignancies, run by AstraZeneca at 5 sites in Japan.
Trial summary
The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Advanced Solid Malignancies
- What is being tested?
- MEDI-575
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 5 sitesJapan
- Study dates
- Mar 2010to Nov 2012
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having advanced solid malignancy for which no curative or standard therapies exist
- Karnofsky performance status of ≥60
- Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)
Who cannot join
- Inadequate bone marrow reserve or organ function
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures
- History of allergy or reaction to any component of the MEDI-575 and/or monoclonal antibody
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Japan5 sites
Research Site
Chuo-ku, Tokyo
Research Site
Kashiwa, Chiba
Research Site
Matsuyama, Ehime
Research Site
Nagoya, Aichi-ken
Research Site
Sunto-gun
About this study
Official title: A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies
The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).
- Conditions
- Advanced Solid Malignancies
- Being tested
- MEDI-575
- Keywords
- cancer, tumor, hepatocellular carcinoma
- Medical subject headings
- Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEDI-575Drug
MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: MEDI-575 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign
Measured: 30 days after the last dose of MEDI-575
Secondary outcomes (3)
Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion
Measured: 30 days after last dose of study drug
To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies
Measured: 3 months after last dose of study drug
Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: 3 months after last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid MalignanciesStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01102400
- Sponsor's protocol ID
- D2840C00001
- Status last verified
- Feb 2013
- First submitted
- 31 Mar 2010
- Last updated
- 6 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Murakami H, Ikeda M, Okusaka T, Inaba Y, Iguchi H, Yagawa K, Yamamoto N. A Phase I study of MEDI-575, a PDGFRalpha monoclonal antibody, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):631-9. doi: 10.1007/s00280-015-2832-6. Epub 2015 Jul 30.
PubMed 26223436
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-Label Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of MEDI-575 in Patients With Advanced Solid Malignancies
- ClinicalTrials.gov ID
- NCT01102400
- Acronym / sponsor ID
- D2840C00001
- Conditions
- Advanced Solid Malignancies
- Keywords
- cancer, tumor, hepatocellular carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- MedImmune LLC
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 13 Apr 2010 (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.
The purpose of this study is to evaluate the safety and tolerability of MEDI-575 in Japanese patients with advanced solid tumors (dose escalation part) and hepatocellular carcinoma (expansion part).
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-575 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Having advanced solid malignancy for which no curative or standard therapies exist
- Karnofsky performance status of ≥60
- Patients must have histological confirmed diagnosis of HCC with no standard therapy available (for only expansion part)
Key exclusion criteria (3 listed)
- Inadequate bone marrow reserve or organ function
- Major surgery within 4 weeks or minor surgery within 2 weeks prior to receipt of MEDI-575. Patients must have no unhealed wounds or unhealed fractures
- History of allergy or reaction to any component of the MEDI-575 and/or 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-575MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part | Drug | 1 |
Primary outcome
Safety and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign
Time frame: 30 days after the last dose of MEDI-575
3 secondary outcomes
Pharmacokinetic variables of MEDI-575 by assessment of drug concentrations in serum after intravenous infusion
Time frame: 30 days after last dose of study drug
To evaluate the immunogenicity of MEDI-575 by measuring anti-MEDI-575 antibodies
Time frame: 3 months after last dose of study drug
Anti-tumor activity of MEDI-575 using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 3 months after last dose of study drug
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 6 Feb 2013.
- Derived from this study: PubMed 26223436Murakami H, Ikeda M, Okusaka T, Inaba Y, Iguchi H, Yagawa K, Yamamoto N. A Phase I study of MEDI-575, a PDGFRalpha monoclonal antibody, in Japanese patients with advanced solid tumors. Cancer Chemother Pharmacol. 2015 Sep;76(3):631-9. doi: 10.1007/s00280-015-2832-6. Epub 2015 Jul 30.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 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-575 in people with Advanced Solid Malignancies, run by AstraZeneca at 5 sites in Japan.
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 3 inclusion and 3 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 6 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Japan. 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 and tolerability assessed primarily by adverse events including abnormal values of clinical laboratory test, ECG and vital sign (time frame: 30 days after the last dose of MEDI-575). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01102400, which also lists 1 linked publication.
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 6 Feb 2013.