NeoplasmsPhase 1NCT01049061
A Study of MORAb-003 in Patients With Solid Tumor
A Phase 1 study testing MORAb-003 in people with Neoplasms and Solid Tumor, run by Eisai Co., Ltd. at 2 sites in Japan.
Trial summary
MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Neoplasms, Solid Tumor
- What is being tested?
- MORAb-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesJapan
- Study dates
- Jan 2010to Feb 2013
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Japanese male and female aged >or=20 to <80 years at obtaining informed consent
- Patient with histologically or cytologically diagnosed solid tumor
- Patient who is FRα-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRα-positive is frequently reported)
- Patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have no other appropriate treatment
- Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group（ECOG）criteria
Who cannot join
- Brain metastasis presenting clinical symptoms or requiring medical treatment
- Serious and systemic infection requiring medical treatment
- History of hypersensitivity to protein formulations including monoclonal antibody
- With other active malignancy (except for carcinoma in situ)
- With a large volume of pleural effusion or ascites requiring drainage
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Phase 1 Study of MORAb-003 in Patients With Solid Tumor
MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.
- Conditions
- Neoplasms, Solid Tumor
- Being tested
- MORAb-003
- Keywords
- Cancer, FRα
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MORAb-003Drug
MORAb-003 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose
| Study group | Role | What they receive |
|---|---|---|
| MORAb-003 | Experimental | Not described Receives: Drug: MORAb-003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To investigate dose-limiting toxicity and estimate maximum tolerated dose.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2013
- Study completionFeb 2013
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 NeoplasmsStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chifumi Kitamura, Study director, JAC PCU Eisai Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01049061
- Sponsor's protocol ID
- MORAB-003-J081-102
- Status last verified
- Feb 2014
- First submitted
- 13 Jan 2010
- Last updated
- 11 Jun 2020
- Results posted
- No
Publications
Sasaki Y, Miwa K, Yamashita K, Sunakawa Y, Shimada K, Ishida H, Hasegawa K, Fujiwara K, Kodaira M, Fujiwara Y, Namiki M, Matsuda M, Takeuchi Y, Katsumata N. A phase I study of farletuzumab, a humanized anti-folate receptor alpha monoclonal antibody, in patients with solid tumors. Invest New Drugs. 2015 Apr;33(2):332-40. doi: 10.1007/s10637-014-0180-8. Epub 2014 Nov 9.
PubMed 25380636
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of MORAb-003 in Patients With Solid Tumor
- ClinicalTrials.gov ID
- NCT01049061
- Acronym / sponsor ID
- MORAB-003-J081-102
- Conditions
- Neoplasms, Solid Tumor
- Keywords
- Cancer, FRα
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2010
- Primary completion
- Jan 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 14 Jan 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.
MORAb-003 is intravenously administered to Japanese patients with folate receptor-alpha expressing solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MORAb-003 | Experimental | Drug: MORAb-003 |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Japanese male and female aged >or=20 to <80 years at obtaining informed consent
- Patient with histologically or cytologically diagnosed solid tumor
- Patient who is FRα-positive confirmed by immunohistochemistry (IHC) (except for ovarian cancer that FRα-positive is frequently reported)
- Patients with a folate-receptor alpha expressing solid tumor who are not responsive or resistant to standard therapy and have no other appropriate treatment
- Performance Status (PS) is 0 to 1 by Eastern Cooperative Oncology Group（ECOG）criteria
Key exclusion criteria (5 listed)
- Brain metastasis presenting clinical symptoms or requiring medical treatment
- Serious and systemic infection requiring medical treatment
- History of hypersensitivity to protein formulations including monoclonal antibody
- With other active malignancy (except for carcinoma in situ)
- With a large volume of pleural effusion or ascites requiring drainage
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 |
|---|---|---|
| MORAb-003MORAb-003 is intravenously administered to patients with solid tumor once a week for 4 weeks as 1 cycle in order to investigate dose-limiting toxicity and estimate maximum tolerated dose | Drug | MORAb-003 |
Primary outcome
To investigate dose-limiting toxicity and estimate maximum tolerated dose.
Time frame: 7 weeks
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 11 Jun 2020.
- Derived from this study: PubMed 25380636Sasaki Y, Miwa K, Yamashita K, Sunakawa Y, Shimada K, Ishida H, Hasegawa K, Fujiwara K, Kodaira M, Fujiwara Y, Namiki M, Matsuda M, Takeuchi Y, Katsumata N. A phase I study of farletuzumab, a humanized anti-folate receptor alpha monoclonal antibody, in patients with solid tumors. Invest New Drugs. 2015 Apr;33(2):332-40. doi: 10.1007/s10637-014-0180-8. Epub 2014 Nov 9.
Related trials for Neoplasms
RecruitingPhase 1
A Study to Evaluate the Safety and Antitumor Activity of GS-1206 in Adults With Solid Tumors
Solid Tumor
RecruitingPhase 1
A Study of LY4584180 in Adult Participants With Previously Treated Blood Cancers
Lymphoma, Non-Hodgkin's, Lymphoma, Diffuse Large B-Cell
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 3
A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
Breast Cancer
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.
Chifumi Kitamura study director
JAC PCU Eisai Co., Ltd.
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 MORAb-003 in people with Neoplasms and Solid Tumor, run by Eisai Co., Ltd. at 2 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 5 inclusion and 5 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 11 Jun 2020. 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 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?
To investigate dose-limiting toxicity and estimate maximum tolerated dose. (time frame: 7 weeks). 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 NCT01049061, 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 11 Jun 2020.