A Phase 1 Dose-escalation Trial of SGN-75 in CD70-positive Non-Hodgkin Lymphoma or Renal Cell Carcinoma

NCT ID: NCT01015911

Last Updated: 2014-12-18

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2012-03-31

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 patients with CD70-positive relapsed or refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma.

Detailed Description

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Conditions

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Carcinoma, Renal Cell Lymphoma, Non-Hodgkin

Keywords

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Antibodies, Monoclonal Antibody-Drug Conjugate Antigens, CD70 Lymphoma, Non-Hodgkin Carcinoma, Renal Cell Immunotherapy Drug Therapy monomethylauristatin F

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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1

SGN-75

Group Type EXPERIMENTAL

SGN-75

Intervention Type DRUG

SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg

Interventions

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SGN-75

SGN-75 (IV) in 21- or 28-day cycles; dose range: 0.3-9 mg/kg

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pathologically-confirmed diagnosis of NHL or RCC
* Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy
* Confirmed CD70 expression
* Measurable disease, defined as at least 1 lesion \>1.5 cm in the greatest transverse diameter for patients with NHL, and at least 1 non-resectable tumor lesion \> or equal to 10 mm in diameter for patients with RCC

Exclusion Criteria

* Previously received an allogeneic transplant
* History of another primary malignancy that has not been in remission for at least 3 years
* Prior anti-CD70-directed therapy
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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Nancy Whiting, PharmD, BCOP

Role: STUDY_DIRECTOR

Seagen Inc.

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

UCLA Medical Center / University of California at Los Angeles

Los Angeles, California, United States

Site Status

Karmanos Cancer Institute / Wayne State University

Detroit, Michigan, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

MD Anderson Cancer Center / University of Texas

Houston, Texas, United States

Site Status

Seattle Cancer Care Alliance / University of Washington

Seattle, Washington, United States

Site Status

Countries

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United States

References

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Tannir NM, Forero-Torres A, Ramchandren R, Pal SK, Ansell SM, Infante JR, de Vos S, Hamlin PA, Kim SK, Whiting NC, Gartner EM, Zhao B, Thompson JA. Phase I dose-escalation study of SGN-75 in patients with CD70-positive relapsed/refractory non-Hodgkin lymphoma or metastatic renal cell carcinoma. Invest New Drugs. 2014 Dec;32(6):1246-57. doi: 10.1007/s10637-014-0151-0. Epub 2014 Aug 22.

Reference Type RESULT
PMID: 25142258 (View on PubMed)

Other Identifiers

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SGN75-001

Identifier Type: -

Identifier Source: org_study_id