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A Safety Study of SGN-2FF for Patients With Advanced Solid Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02952989
Recruitment Status : Terminated (Due to overall benefit/risk profile)
First Posted : November 2, 2016
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE October 27, 2016
First Posted Date  ICMJE November 2, 2016
Last Update Posted Date July 19, 2019
Actual Study Start Date  ICMJE February 23, 2017
Actual Primary Completion Date June 24, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • The number of participants with adverse events that are related to treatment [ Time Frame: Up to 90 days following last dose ]
    The number of patients who have side effects that are related to the study drug
  • The number of participants with laboratory abnormalities that are related to treatment [ Time Frame: Up to 90 days following last dose ]
    The number of patients who have laboratory test results that are outside the normal range
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 28 days from first dose ]
    The rate of occurrence of side effects that prevent giving more of the treatment
Original Primary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • The number of participants with adverse events that are related to treatment [ Time Frame: Through 1 month following last dose ]
  • The number of participants with laboratory abnormalities that are related to treatment [ Time Frame: Through 1 month following last dose ]
  • Incidence of dose-limiting toxicities (DLTs) [ Time Frame: 28 days from first dose ]
Change History Complete list of historical versions of study NCT02952989 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2018)
  • Pharmacokinetic assessments [ Time Frame: Relative to most recent dosing event ]
    Selected PK parameters, including area under the curve, maximum observed concentration, time to maximum observed concentration, and trough concentration.
  • Markers of fucosylation status [ Time Frame: Up to 90 days following last dose ]
    Changes in pharmacodynamic biomarkers of fucosylation across dose levels
  • Objective response rate [ Time Frame: Up to 90 days following last dose ]
    The proportion of patients who achieve a complete response (CR) or partial response (PR).
  • Disease control rate [ Time Frame: Up to approximately 5 years ]
    The proportion of patients who achieve either complete response (CR), partial response (PR), or stable disease (SD)
  • Duration of response [ Time Frame: Up to approximately 5 years ]
    The time from the first documentation of objective response (CR or PR) to the first documentation of tumor progression (progressive disease per response criteria or clinical disease progression) or to death due to any cause, whichever comes first
  • Clinical benefit rate [ Time Frame: Up to approximately 5 years ]
    The proportion of patients who achieve either complete response (CR), partial response (PR), or stable disease (SD) for at least 24 weeks
  • Progression-free survival [ Time Frame: Up to approximately 5 years ]
    The time from start of study treatment to the first documentation of tumor progression (progressive disease per response criteria or clinical disease progression) or death due to any cause, whichever comes first
  • Overall survival [ Time Frame: Up to approximately 5 years ]
    The time from start of study treatment to date of death due to any cause
Original Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2016)
  • Estimate of area under the concentration-time curve [ Time Frame: Through 1 month following last dose ]
  • Estimate of maximum concentration [ Time Frame: Through 1 month following last dose ]
  • Estimate of time to maximum concentration [ Time Frame: Through 1 month following last dose ]
  • Estimate of trough concentration [ Time Frame: Through 1 month following last dose ]
  • Markers of fucosylation status [ Time Frame: Through 1 month following last dose ]
  • Objective response rate [ Time Frame: Through 1 month following last dose ]
  • Disease control rate [ Time Frame: Up to approximately 5 years ]
  • Duration of response [ Time Frame: Up to approximately 5 years ]
  • Clinical benefit rate [ Time Frame: Up to approximately 5 years ]
  • Progression-free survival [ Time Frame: Up to approximately 5 years ]
  • Overall survival [ Time Frame: Up to approximately 5 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety Study of SGN-2FF for Patients With Advanced Solid Tumors
Official Title  ICMJE A Phase 1, Multicenter, Open-label, Dose-escalation Study of SGN-2FF in Patients With Advanced Solid Tumors
Brief Summary

This study is being done to find out the side effects (unwanted effects) that are caused in patients with cancers who are given SGN-2FF. This study will also attempt to find the most suitable dose in the disease or condition being studied and look at other effects of SGN2FF, including its effect on cancer.

This study has several different parts. Part A will try to find the highest safe dose. Part B will enroll more patients to be treated at the highest safe dose or a lower dose to better understand how well SGN-2FF is tolerated. Part C will try to find the highest safe dose of SGN-2FF when it is given combined with pembrolizumab. Pembrolizumab is a standard treatment for cancer. Part D will enroll more patients to be treated at the highest safe dose of SGN-2FF combined with pembrolizumab or a lower dose of SGN-2FF to better understand how well SGN-2FF is tolerated when it is given with pembrolizumab.

Detailed Description

This is a phase 1, open-label, multicenter, dose escalation study that will examine the safety profile of SGN-2FF given orally to patients with advanced solid tumors. The primary goal of the study is to identify the maximum tolerated dose (MTD), or optimal biological dose (OBD) that does not exceed the MTD. The pharmacokinetics (PK) and antitumor activity of SGN-2FF will also be evaluated. In this study, SGN-2FF will be evaluated as monotherapy and as combination therapy with the standard approved dose of pembrolizumab.

The monotherapy portion of the study will be conducted in 2 sequential parts (Part A and Part B). Part A will enroll patients for dose escalation to estimate the MTD /OBD and help determine the dosing regimen that will be tested in Part B. The OBD will be evaluated by assessing the activity of SGN-2FF, including pharmacodynamics, PK, and other observations in dose escalation. Part B will explore the recommended dose/regimen in up to 3 focused expansion cohorts.

The combination therapy portion of the study will be conducted in 2 sequential parts (Part C and Part D). SGN-2FF will be administered orally according to the dose and schedule assigned, with a lead-in period of 2 weeks prior to pembrolizumab administration. The lead-in period may be discontinued based on emerging nonclinical and/or clinical data. Part C will enroll patients for dose escalation to estimate the MTD /OBD and the dosing regimen that will be tested in Part D. Part D will explore the recommended dose/regimen in up to 3 focused expansion cohorts.

Safety will be monitored throughout the trial by the safety monitoring committee which will meet frequently to review the emerging safety data and make dose-escalation and dosing-interval recommendations. Antitumor activity will be assessed by radiographic imaging. Patients may continue treatment until progression of their disease or intolerable side effects.

Retreatment with SGN-2FF monotherapy or with SGN-2FF and pembrolizumab combination therapy is permitted with medical monitor approval for patients who achieve stable disease, a complete response, or partial response on study and then experience disease progression after discontinuing prior treatment with SGN 2FF.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma, Renal Cell
  • Breast Neoplasms
  • Urinary Bladder Neoplasm
  • Carcinoma, Squamous Cell of Head and Neck
  • Colorectal Neoplasms
  • Gastric Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma
Intervention  ICMJE
  • Drug: SGN-2FF
    SGN-2FF oral daily dosing.
    Other Name: 2-fluorofucose
  • Drug: pembrolizumab
    200 mg every 3 weeks by IV infusion
    Other Name: Keytruda
Study Arms  ICMJE
  • Experimental: SGN-2FF
    Dose escalation and dose expansion
    Intervention: Drug: SGN-2FF
  • Experimental: SGN-2FF and Pembrolizumab
    Dose escalation and dose expansion
    Interventions:
    • Drug: SGN-2FF
    • Drug: pembrolizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 8, 2019)
47
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2016)
158
Actual Study Completion Date  ICMJE June 24, 2019
Actual Primary Completion Date June 24, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with histologically or cytologically-confirmed, locally advanced, or metastatic solid malignancy that is relapsed, refractory, or progressing following at least 1 prior systemic therapy (Part A)
  • Measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) as defined by RECIST 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 1
  • Patients in Part B must have histologically or cytologically-confirmed, locally-advanced, or metastatic solid malignancy within the disease indications of Part A
  • Adequate baseline hematologic, renal, and hepatic function
  • Patients for whom there is no further standard therapy available at the time of enrollment (Part A)
  • Patients with a histologically-confirmed, advanced solid malignancy meeting one of the following criteria: (1) indication for which pembrolizumab is approved or (2) relapsed, refractory, or progressive disease following at least 1 prior therapy and for which no further standard therapy is a available (Parts C and D)

Exclusion Criteria:

  • Patients with carcinomatous meningitis or active central nervous system (CNS) metastases
  • Patients with recent (within 14 days) or serious ongoing infection
  • Patients requiring systemic treatment with corticosteroids (greater than 10 mg prednisone equivalents) or immunosuppressive medications within 14 days of enrollment
  • Patients with active known or suspected autoimmune disease or significant autoimmune-related toxicity from prior immuno-oncology therapy
  • Known active or latent tuberculosis
  • Uncontrolled diabetes mellitus
  • History of interstitial lung disease
  • Gastrointestinal abnormality that would affect absorption of SGN-2FF
  • Patients tested positive for hepatitis B or with a known, active hepatitis C infection
  • Women who are pregnant or breastfeeding
  • Patients with deep vein thrombosis (DVT)
  • Contraindication to prophylactic anticoagulation
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02952989
Other Study ID Numbers  ICMJE SGN2FF-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Christina Derleth, MD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP