Renal Cell CarcinomaPhase 1NCT01677390
A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma
A Phase 1 study testing SGN-75 and everolimus in people with Renal Cell Carcinoma, run by Seagen Inc. at 8 sites in United States.
Trial summary
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- SGN-75 and everolimus
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 8 sitesUnited States
- Study dates
- Aug 2012to Dec 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
- Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression
- Previously treated with at least 1 tyrosine kinase inhibitor (TKI)
- Measurable disease
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate lung and renal function
Who cannot join
- Prior treatment with anti-CD70-directed therapy
- Received more than one prior treatment with an mTOR inhibitor
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
UNC Lineberger Comprehensive Cancer Center / University of North Carolina
Chapel Hill, North Carolina, 27599
Rocky Mountain Cancer Centers - Midtown
Denver, Colorado, 80218
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, 48201
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Miriam Hospital, The
Providence, Rhode Island, 02906
Seattle Cancer Care Alliance / University of Washington
Seattle, Washington, 98109-1023
Stanford Cancer Center
Stanford, California, 94305
About this study
Official title: A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma
This is a phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell carcinoma.
- Conditions
- Renal Cell Carcinoma
- Being tested
- SGN-75, everolimus
- Keywords
- Antibody-Drug Conjugate, monomethylauristatin F, Carcinoma, Renal Cell, Antigens, CD70, Drug Therapy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGN-75Drug
1-2 mg/kg IV every 21 days
everolimusDrug
10 mg PO daily
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | SGN-75, everolimus Receives: Drug: SGN-75; Drug: everolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and laboratory abnormalities
Measured: Through 1 month post last dose
Secondary outcomes (5)
Best clinical response according to RECIST Version 1.1
Measured: Through 1 month post last dose
Progression-free survival
Measured: Until disease progression or start of new anticancer treatment, an expected average of 6 months
Overall survival
Measured: Until death or study closure, an expected average of 1 year
Blood concentrations of SGN-75 and metabolites
Measured: Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose
Incidence of antitherapeutic antibodies
Measured: Pre-dose in most cycles and 1 month post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seagen Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elaina Gartner, MD, Study director, Seagen Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01677390
- Sponsor's protocol ID
- SGN75-002
- Status last verified
- Jan 2014
- First submitted
- 23 Aug 2012
- Last updated
- 28 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Dose-escalation Study to Evaluate the Safety and Tolerability of SGN-75 in Combination With Everolimus in Patients With CD70-positive Metastatic Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT01677390
- Acronym / sponsor ID
- SGN75-002
- Conditions
- Renal Cell Carcinoma
- Keywords
- Antibody-Drug Conjugate, monomethylauristatin F, Carcinoma, Renal Cell, Antigens, CD70, Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Seagen Inc.Industry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 3 Sep 2012 (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 phase 1, open-label, dose-escalation clinical trial to evaluate the safety of SGN-75 in combination with everolimus in patients with CD70-positive metastatic renal cell carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: SGN-75, Drug: everolimusSGN-75, everolimus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression
- Previously treated with at least 1 tyrosine kinase inhibitor (TKI)
- Measurable disease
- Eastern Cooperative Oncology Group performance status 0 or 1
- Adequate lung and renal function
Key exclusion criteria (2 listed)
- Prior treatment with anti-CD70-directed therapy
- Received more than one prior treatment with an mTOR inhibitor
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 |
|---|---|---|
| SGN-751-2 mg/kg IV every 21 days | Drug | Arm 1 |
| everolimus10 mg PO daily | Drug | Arm 1 |
Primary outcome
Incidence of adverse events and laboratory abnormalities
Time frame: Through 1 month post last dose
5 secondary outcomes
Best clinical response according to RECIST Version 1.1
Time frame: Through 1 month post last dose
Progression-free survival
Time frame: Until disease progression or start of new anticancer treatment, an expected average of 6 months
Overall survival
Time frame: Until death or study closure, an expected average of 1 year
Blood concentrations of SGN-75 and metabolites
Time frame: Cycle 1: pre-dose, 30 minutes, and 2, 4, 8, 24, 168, and 336 hours post dose start; pre-dose in subsequent cycles, and 1 month post last dose
Incidence of antitherapeutic antibodies
Time frame: Pre-dose in most cycles and 1 month post last dose
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2014.
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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.
Elaina Gartner, MD study director
Seagen Inc.
8 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 SGN-75 and everolimus in people with Renal Cell Carcinoma, run by Seagen Inc. at 8 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 5 inclusion and 2 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 28 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. 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 and laboratory abnormalities (time frame: Through 1 month post last dose). 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 28 Jan 2014.