NCT01677390

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

1.3 years

First QC Date

August 23, 2012

Last Update Submit

January 24, 2014

Conditions

Renal Cell Carcinoma

Keywords

Antibody-Drug Conjugatemonomethylauristatin FCarcinoma, Renal CellAntigens, CD70Drug Therapy

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events and laboratory abnormalities

    Through 1 month post last dose

Secondary Outcomes (5)

  • Best clinical response according to RECIST Version 1.1

    Through 1 month post last dose

  • Progression-free survival

    Until disease progression or start of new anticancer treatment, an expected average of 6 months

  • Overall survival

    Until death or study closure, an expected average of 1 year

  • Blood concentrations of SGN-75 and metabolites

    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

    Pre-dose in most cycles and 1 month post last dose

Study Arms (1)

Arm 1

EXPERIMENTAL

SGN-75, everolimus

Drug: SGN-75Drug: everolimus

Interventions

SGN-75DRUG

1-2 mg/kg IV every 21 days

Arm 1
everolimusDRUG

10 mg PO daily

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior treatment with anti-CD70-directed therapy
  • Received more than one prior treatment with an mTOR inhibitor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Stanford Cancer Center

Stanford, California, 94305, United States

Location

Rocky Mountain Cancer Centers - Midtown

Denver, Colorado, 80218, United States

Location

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, 48201, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Miriam Hospital, The

Providence, Rhode Island, 02906, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, 98109-1023, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

SGN-75 antibody-drug conjugateEverolimus

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsKidney NeoplasmsUrologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

SirolimusMacrolidesLactonesOrganic Chemicals

Study Officials

  • Elaina Gartner, MD

    Seagen Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2012

First Posted

September 3, 2012

Study Start

August 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

US(8)