Carcinoma, Renal CellPhase 1NCT00816686
A Phase 1 Study of the Safety and Pharmacokinetics of AGS-16M18 in Subjects With Advanced Renal Cell Cancer
A Phase 1 study testing AGS-16M18 in people with Carcinoma, Renal Cell and Kidney Neoplasms, run by Astellas Pharma Inc at 2 sites in United States.
Trial summary
This is a first in human study of AGS-16M18 given every week to subjects with advanced renal cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days until the disease worsens. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases
- What is being tested?
- AGS-16M18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2008to Apr 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
- Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amendable to cure by surgery or other means, and must have failed at least one prior systemic therapy, including but not limited to treatment with sunitinib, temsirolimus or sorafenib
- Evaluable/Measureable disease according to Response Criteria for Solid tumors
- Eastern Cooperative Group performance status of 0-1
- Therapeutic anti-coagulation (PT, and/or INR, PTT) permitted, if clinically stable and >/= 3 months from initiation
Who cannot join
- Past or present documented central nervous system (CNS) tumor or CNS metastasis
- Use of investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
- History of thromboembolic events and bleeding disorders </= 3 months (e.g., DVT or PE)
- Major Surgery (that requires general anesthesia) within 4 weeks of study enrollment
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Baltimore, Maryland, 21231
Study site
New York, New York, 10021
About this study
Official title: A Phase 1, Open-Label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M18 Given as Monotherapy in Subjects With Advanced Renal Cell Carcinoma
This is a first in human study of AGS-16M18 given every week to subjects with advanced renal cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days until the disease worsens.
Read the detailed description
Subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard, dose escalation study design. A disease assessment will be performed at study week 5 (+/- 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may receive AGS-16M18 extended therapy at the dose and schedule of their assigned cohort until disease progression or intolerability of AGS-16M18. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-16M18.
- Conditions
- Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases
- Being tested
- AGS-16M18
- Keywords
- clinical trial, phase 1, carcinoma, advanced renal cell, kidney, pharmacokinetics, safety, AGS-16M18
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGS-16M18Biological
IV Infusion
| Study group | Role | What they receive |
|---|---|---|
| 1. AGS-16M18 Dose 1 | Experimental | Not described Receives: Biological: AGS-16M18 |
| 2. AGS-16M18 Dose 2 | Experimental | Not described Receives: Biological: AGS-16M18 |
| 3. AGS-16M18 Dose 3 | Experimental | Not described Receives: Biological: AGS-16M18 |
| 4. AGS-16M18 Dose 4 | Experimental | Not described Receives: Biological: AGS-16M18 |
| 5. AGS-16M18 Dose 5 | Experimental | Not described Receives: Biological: AGS-16M18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events
Measured: Throughout the treatment
Assessment of PK variables
Measured: Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose
Secondary outcomes (2)
Incidence of anti-AGS-16M18 antibody formation
Measured: Week 0, week 1, week 4, week 8, every 8 weeks during extension period, 2 and 3 months after last dose
Changes in tumor status
Measured: Week 5, week 8, every 8 weeks during extension period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startOct 2008
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: Trial was terminated due to the need to re-formulate the study drug.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Renal CellStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Astellas Pharma Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Agensys, Inc.
- Responsible party
- Sponsor
- Investigators
- Use Central Contact, Study director, Agensys, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816686
- Sponsor's protocol ID
- 2007002
- Status last verified
- May 2010
- First submitted
- 1 Jan 2009
- Last updated
- 27 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label, Multi-center, Dose Escalation Study of the Safety and Pharmacokinetics of AGS-16M18 Given as Monotherapy in Subjects With Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT00816686
- Acronym / sponsor ID
- 2007002
- Conditions
- Carcinoma, Renal Cell, Kidney Neoplasms, Kidney Diseases
- Keywords
- clinical trial, phase 1, carcinoma, advanced renal cell, kidney, pharmacokinetics, safety, AGS-16M18
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Trial was terminated due to the need to re-formulate the study drug.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Astellas Pharma IncIndustry (pharma, biotech, devices)
- Collaborators
- Agensys, Inc.
- Study start
- Oct 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 5 Jan 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.
This is a first in human study of AGS-16M18 given every week to subjects with advanced renal cell cancer. AGS-16M18 will be administered as a 60 minute IV infusion on consecutive days until the disease worsens.
Detailed description
Subjects will be enrolled sequentially into 5 planned dose cohorts according to a standard, dose escalation study design. A disease assessment will be performed at study week 5 (+/- 3 days) by the investigator. The assessment will be based both on changes in clinical symptoms, and radiographic images. Subjects without evidence of disease progression may receive AGS-16M18 extended therapy at the dose and schedule of their assigned cohort until disease progression or intolerability of AGS-16M18. Disease assessments will be performed every 8 weeks during the extended period. A safety follow-up visit will occur 4 weeks after the last infusion of AGS-16M18.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1. AGS-16M18 Dose 1 | Experimental | Biological: AGS-16M18 |
| 2. AGS-16M18 Dose 2 | Experimental | Biological: AGS-16M18 |
| 3. AGS-16M18 Dose 3 | Experimental | Biological: AGS-16M18 |
| 4. AGS-16M18 Dose 4 | Experimental | Biological: AGS-16M18 |
| 5. AGS-16M18 Dose 5 | Experimental | Biological: AGS-16M18 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologic or cytologic diagnosis (recent or remote) of metastatic renal cell carcinoma (including papillary, clear cell, and excluding transitional cell types) that is not amendable to cure by surgery or other means, and must have failed at least one prior systemic therapy, including but not limited to treatment with sunitinib, temsirolimus or sorafenib
- Evaluable/Measureable disease according to Response Criteria for Solid tumors
- Eastern Cooperative Group performance status of 0-1
- Therapeutic anti-coagulation (PT, and/or INR, PTT) permitted, if clinically stable and >/= 3 months from initiation
Key exclusion criteria (4 listed)
- Past or present documented central nervous system (CNS) tumor or CNS metastasis
- Use of investigational drug (including marketed drugs not approved for this indication) within 4 weeks prior to screening or 5 half-lives of the prior investigational drug (whichever is longer)
- History of thromboembolic events and bleeding disorders </= 3 months (e.g., DVT or PE)
- Major Surgery (that requires general anesthesia) within 4 weeks of study enrollment
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 |
|---|---|---|
| AGS-16M18IV Infusion | Biological | 1. AGS-16M18 Dose 1, 2. AGS-16M18 Dose 2, 3. AGS-16M18 Dose 3, 4. AGS-16M18 Dose 4, 5. AGS-16M18 Dose 5 |
Primary outcome
Incidence of adverse events
Time frame: Throughout the treatment
Assessment of PK variables
Time frame: Weeks 0 - 5, week 8, weekly during extension period, 2 and 3 months after last dose
2 secondary outcomes
Incidence of anti-AGS-16M18 antibody formation
Time frame: Week 0, week 1, week 4, week 8, every 8 weeks during extension period, 2 and 3 months after last dose
Changes in tumor status
Time frame: Week 5, week 8, every 8 weeks during extension period
Results and safety
The study was stopped early (reason given: Trial was terminated due to the need to re-formulate the study drug.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2013.
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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.
Use Central Contact study director
Agensys, Inc.
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 AGS-16M18 in people with Carcinoma, Renal Cell and Kidney Neoplasms, run by Astellas Pharma Inc 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 4 inclusion and 4 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 27 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 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: Trial was terminated due to the need to re-formulate the study drug.). 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?
Incidence of adverse events (time frame: Throughout the treatment). The study lists 2 primary outcomes in all. 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 27 Feb 2013.