A Phase 1b Study of SGN-75 in Combination With Everolimus... | NCT01677390

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

NCT01677390

Sponsor

Seagen Inc.

Status

Terminated

Last Update Posted

Jan 28, 2014Estimated

Enrollment

4Actual

Phase

Phase 1

Conditions

Renal Cell Carcinoma

Interventions

SGN-75
everolimus

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2014

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Aug 23, 2012

First Submission Date that Met QC Criteria

Aug 29, 2012

First Posted Date

Sep 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 24, 2014

Last Update Posted Date

Jan 28, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

4Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Arm 1	Experimental	SGN-75, everolimus	Drug: SGN-75 Drug: everolimus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SGN-75	Drug	1-2 mg/kg IV every 21 days	Arm 1
everolimus

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events and laboratory abnormalities		Through 1 month post last dose

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Elaina Gartner, MD	Seagen Inc.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford Cancer Center		Stanford	California	94305	United States
Rocky Mountain Cancer Centers - Midtown

Condition Browse Module

MeSH Terms

ID	Term
D002292	Carcinoma, Renal Cell

Ancestor Terms

ID	Term
D000230	Adenocarcinoma
D002277	Carcinoma
D009375	Neoplasms, Glandular and Epithelial
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000599296	SGN-75 antibody-drug conjugate
D000068338	Everolimus

Ancestor Terms

ID	Term
D020123	Sirolimus
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided