A Phase 1b Study of SGN-75 in Combination With Everolimus in Patients With Renal Cell Carcinoma

NCT ID: NCT01677390

Last Updated: 2014-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

SGN-75, everolimus

Group Type EXPERIMENTAL

SGN-75

Intervention Type DRUG

1-2 mg/kg IV every 21 days

everolimus

Intervention Type DRUG

10 mg PO daily

Interventions

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SGN-75

1-2 mg/kg IV every 21 days

Intervention Type DRUG

everolimus

10 mg PO daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Prior treatment with anti-CD70-directed therapy
* Received more than one prior treatment with an mTOR inhibitor
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seagen Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elaina Gartner, MD

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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Stanford Cancer Center

Stanford, California, United States

Site Status

Rocky Mountain Cancer Centers - Midtown

Denver, Colorado, United States

Site Status

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

UNC Lineberger Comprehensive Cancer Center / University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Miriam Hospital, The

Providence, Rhode Island, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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SGN75-002

Identifier Type: -

Identifier Source: org_study_id

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