Suspended
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
What is being tested
SGN-75
+ everolimus
Drug
Who is being recruted
Urogenital Diseases+13
+ Adenocarcinoma
+ Carcinoma
Over 18 Years
+7 Eligibility Criteria
How is the trial designed
Treatment Study
Phase 1
Interventional
Study Start: August 2012
Summary
Principal SponsorSeagen Inc.
Last updated: January 28, 2014
Sourced from a government-validated database.Claim as a partner
Study start date: August 1, 2012
Actual date on which the first participant was enrolled.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.
Principal SponsorSeagen Inc.
Last updated: January 28, 2014
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
4 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Conditions
Criteria
Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Urogenital DiseasesAdenocarcinomaCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney NeoplasmsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesCarcinoma, Renal Cell
Criteria
5 inclusion criteria required to participate
Adequate lung and renal function
Diagnosis of metastatic renal cell carcinoma with confirmed CD70 expression
Eastern Cooperative Oncology Group performance status 0 or 1
Measurable disease
Show More Criteria
2 exclusion criteria prevent from participating
Prior treatment with anti-CD70-directed therapy
Received more than one prior treatment with an mTOR inhibitor
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalSGN-75, everolimus
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 8 locations
Rocky Mountain Cancer Centers - Midtown
Denver, United StatesKarmanos Cancer Institute / Wayne State University
Detroit, United StatesMemorial Sloan Kettering Cancer Center
New York, United StatesSuspended8 Study Centers