Advanced CancersPhase 1NCT01021072
A First in Man Study of MABp1 in Patients With Advanced Cancers
A Phase 1 study testing MABp1 in people with Advanced Cancers, run by Janssen Research & Development, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancers
- What is being tested?
- MABp1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2010to 31 Aug 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which thee is no standard therapy that provides benefits for >/= 3 months
- measurable or non-measurable disease at baseline
- at least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
- will not be treated with any other chemotherapy, immunotherapy, radiotherapy or investigational drug while enrolled on this protocol
- age >/= 18 year, male or female
- Eastern Cooperative Oncology Group performance status 0,1,or 2
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- Serum potassium and magnesium levels within institutional normal limits. Total serum calcium or ionized calcium level must be greater than or equal to the low limit of normal.
- Adequate renal function, defined by serum creating </= 1.5 x ULN
- Adequate hepatic function
- Adequate bone marrow function WOCBP, a negative serum pregnancy test result at screening.
- WOCBP or men whose sexual partners are WOCBP who are willing to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication
- Signed and dated IRB approved ICF before any protocol specific screening procedures are performed
Who cannot join
- serious uncontrolled medical disorder or active infection which would impair the patient to receive protocol therapy.
- Uncontrolled or significant cardiovascular diseae
- dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- not recovered from the adverse effects of prior therapy at the time of enrollment </= grade 1
- symptomatic brain metastases which are either untreated or uncontrolled by surgery and or radiotherapy
- received extensive prior radiation therapy to the bone marrow
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- immunocompromised, including subjects know to be infected with HIV
- history of hypersensitivity to compounds of similar chemical or biologic composition to the antibody women how are pregnant or breastfeeding
- WOCBP or men whose sexual partners are WOCBP who are unwilling or unable to use an acceptable method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 3 months after the last dose of study medication
Trial locations and contacts
2 sites in 1 country.
United States2 sites
M.D. Anderson Cancer Institute
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Phase 1 Study of MABp1 in Patients With Advanced Cancers
The purpose of this study is to block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process.
An adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.
- Conditions
- Advanced Cancers
- Being tested
- MABp1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MABp1Drug
0.25 mg/kg,0.75 mg/kg,1.25 mg/kg, 3.75 mg/kg IV (in the vein) on day 1 of each 21 day cycle until progression or unacceptable toxicity develops.
| Study group | Role | What they receive |
|---|---|---|
| MTD | Experimental | The study will utilize a standard 3+3 design for dose escalation. Once the maximum tolerated dose has been reached, an expansion cohort, as well as tumor specific expansion cohorts will be explored. Receives: Drug: MABp1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: one year
Secondary outcomes (2)
Tumor response
Measured: one year
Cachexia Response
Change in LBT as measured by DEXA
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2009 (estimated)
- Study start31 Mar 2010
- Primary completion31 Oct 2012
- Study completion31 Aug 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 Advanced CancersStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01021072
- Sponsor's protocol ID
- 2009-PT004
- Status last verified
- Feb 2021
- First submitted
- 16 Nov 2009
- Last updated
- 16 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. MABp1, a first-in-class true human antibody targeting interleukin-1alpha in refractory cancers: an open-label, phase 1 dose-escalation and expansion study. Lancet Oncol. 2014 May;15(6):656-66. doi: 10.1016/S1470-2045(14)70155-X. Epub 2014 Apr 17.
PubMed 24746841
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of MABp1 in Patients With Advanced Cancers
- ClinicalTrials.gov ID
- NCT01021072
- Acronym / sponsor ID
- 2009-PT004
- Conditions
- Advanced Cancers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2010 (actual)
- Primary completion
- 31 Oct 2012 (actual)
- Study completion
- 31 Aug 2013 (actual)
- First posted
- 26 Nov 2009 (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 block interleukin-1 alpha activity with a True Human monoclonal antibody, thus interrupting the inflammatory response that supports tumor growth/metastasis and which drives the cachexic process.
An adaptive design will be employed which will allow for the exploration of different dosing regimens, as well as tumor types that show preliminary evidence of efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MTD | Experimental | Drug: MABp1The study will utilize a standard 3+3 design for dose escalation. Once the maximum tolerated dose has been reached, an expansion cohort, as well as tumor specific expansion cohorts will be explored. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- pathologically confirmed advanced malignancy that is metastatic or unresectable and which is refractory to standard therapy or for which thee is no standard therapy that provides benefits for >/= 3 months
- measurable or non-measurable disease at baseline
- at least 4 weeks since the last dose of chemotherapy, radiation therapy, immunotherapy, or surgery; at least 6 weeks for therapy which is known to have delayed toxicity; at least 4 weeks since treatment with biologic/targeted therapies; at least 2 weeks since last hormonal therapy
- will not be treated with any other chemotherapy, immunotherapy, radiotherapy or investigational drug while enrolled on this protocol
- age >/= 18 year, male or female
Key exclusion criteria (9 listed)
- serious uncontrolled medical disorder or active infection which would impair the patient to receive protocol therapy.
- Uncontrolled or significant cardiovascular diseae
- dementia or altered mental status that would prohibit the understanding or rendering of informed consent
- not recovered from the adverse effects of prior therapy at the time of enrollment </= grade 1
- symptomatic brain metastases which are either untreated or uncontrolled by surgery and or radiotherapy
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 |
|---|---|---|
| MABp10.25 mg/kg,0.75 mg/kg,1.25 mg/kg, 3.75 mg/kg IV (in the vein) on day 1 of each 21 day cycle until progression or unacceptable toxicity develops. | Drug | MTD |
Primary outcome
Maximum tolerated dose
Time frame: one year
2 secondary outcomes
Tumor response
Time frame: one year
Cachexia Response
Time frame: 8 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 16 Feb 2021.
- Derived from this study: PubMed 24746841Hong DS, Hui D, Bruera E, Janku F, Naing A, Falchook GS, Piha-Paul S, Wheler JJ, Fu S, Tsimberidou AM, Stecher M, Mohanty P, Simard J, Kurzrock R. MABp1, a first-in-class true human antibody targeting interleukin-1alpha in refractory cancers: an open-label, phase 1 dose-escalation and expansion study. Lancet Oncol. 2014 May;15(6):656-66. doi: 10.1016/S1470-2045(14)70155-X. Epub 2014 Apr 17.
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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.
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 MABp1 in people with Advanced Cancers, run by Janssen Research & Development, 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 12 inclusion and 9 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 16 Feb 2021. 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 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?
Maximum tolerated dose (time frame: one year). 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 NCT01021072, 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 16 Feb 2021.