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Trial record 1 of 1 for:    FF-10502
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Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas

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: NCT02661542
Recruitment Status : Active, not recruiting
First Posted : January 22, 2016
Last Update Posted : July 23, 2020
Sponsor:
Information provided by (Responsible Party):
Fujifilm Pharmaceuticals U.S.A., Inc.

Tracking Information
First Submitted Date  ICMJE January 13, 2016
First Posted Date  ICMJE January 22, 2016
Last Update Posted Date July 23, 2020
Actual Study Start Date  ICMJE January 2016
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
Incidence of Treatment Emergent Adverse Events (Safety and Tolerability) [ Time Frame: 33 Months ]
Safety and tolerability assessed by adverse events (AEs), and serious adverse events. (SAEs)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 19, 2016)
  • Determination of overall response rates [ Time Frame: Responses assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug (every 28 days=1 cycle). ]
  • Determination of duration of response. [ Time Frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug ]
  • Determination of duration of stable disease (SD) as measured from time of 1st evidence of response to time of 1st evidence of progressive disease as measured by CT or MRI. [ Time Frame: Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug ]
  • Evaluate progression-free survival (PFS) [ Time Frame: Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug ]
  • Evaluate overall survival (OS) [ Time Frame: Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug ]
  • Evaluate the mean plasma concentrations of FF-10502-01 [ Time Frame: Assessed at Cycle 1 Day 1, and Cycle 1 Day 15 ]
  • Evaluate FF-10502-01 incorporation into whole blood cellular DNA by LC-MS/MS as a pharmacodynamic marker [ Time Frame: Assessed at Cycle 1 Day 1, Cycle 1 Day , Cycle 1 Day 15, Cycle 1, Day 22, Cycle 2 Day 1, at the end of Cycle 2 and ever 2 cycles thereafter up to 24 weeks. ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas
Official Title  ICMJE A Phase 1/2a, Dose-escalation Study of FF-10502-01 for the Treatment of Advanced Solid Tumors and Lymphomas
Brief Summary A Phase 1/2a, dose-escalation study of FF-10502-01 in Patients with Advanced Solid Tumors and Lymphomas. A total of up to 9 cohorts will be enrolled in Phase 1 to establish the MTD. Phase 2 will consist of 2 cohorts: Cohort 1 will include subjects with Pancreatic Cancer. Cohort 2 will include subjects with another tumor type enrolled in the Phase 1 dose-escalation phase who have demonstrated Clinical Benefit by Week 16.
Detailed Description Subjects will receive doses of FF-10502-01 intravenously (IV) weekly for three weeks, repeated every 28 days (= 1 cycle). Disease assessments, based on computed tomography (CT), magnetic resonance image (MRI), and, for lymphoma, [18F]-fluorodeoxyglucose positron emission tomography (FDG-PET) scans, will be obtained at Week 8 and every 8 weeks thereafter until documented progression of disease (PD). Subjects who demonstrate clinical benefit will be allowed to continue therapy with FF-10502-01 until progression of disease, observation of unacceptable adverse events, intercurrent illness or changes in the subject's condition that prevents further study participation.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Solid Tumors
  • Lymphomas
Intervention  ICMJE Drug: FF-10502-01
Study Arms  ICMJE
  • Experimental: Phase 1: Lowest dose of FF-10502-01
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 1: 1.5x lowest dose of FF-10502-01
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 1: 2.25x lowest dose of FF-10502-01
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 1: 3.375x lowest dose of FF-10502-01
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 1: 5x lowest dose of FF-10502-01
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 1: 7.5x lowest dose of FF-10502-01
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 1: 11.25x lowest dose of FF-10502-01
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 1: 16.875x lowest dose of FF-10502-01
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 1: 25x lowest dose of FF-10502-01
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 2a: FF-10502-01 at MTD in Pancreatic Cancer
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
  • Experimental: Phase 2a: FF-10502-01 at MTD in Solid Tumors
    FF-10502-01 will be administered intravenously (IV) on Days 1, 8, and 15 of a 28 day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
    Intervention: Drug: FF-10502-01
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: July 21, 2020)
99
Original Estimated Enrollment  ICMJE
 (submitted: January 19, 2016)
84
Estimated Study Completion Date  ICMJE March 2021
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females ≥ 18 years of age
  • Histologically or cytologically confirmed advanced or metastatic solid tumor or l lymphoma, that is refractory to standard therapy, relapsed after standard therapy, or for which no standard therapy available that is expected to improve survival by at least three months
  • At least 4 weeks beyond the last chemotherapy (or ≥ 5 half-lives for targeted agents, whichever is shorter), radiotherapy, major surgery or experimental treatment and recovered from all acute toxicities (≤ Grade 1)
  • Adequate performance status: Eastern Cooperative Oncology Group (ECOG) ≤ 2
  • Life expectancy of ≥ 3 months
  • Adequate hematologic parameters without ongoing transfusional support:
  • Hemoglobin (Hb) ≥ 9 g/dL
  • Absolute neutrophil count (ANC) ≥ 1.0 x 109 cells/L
  • Platelets ≥ 100 x 109 cells/L
  • Adequate renal and hepatic function:
  • Creatinine ≤ 1.5 x the upper limit of normal (ULN), or calculated creatinine clearance ≥ 60 mL/minute x 1.73 m2 per the Cockcroft-Gault formula
  • Total bilirubin ≤ 2 times the upper limit of normal (ULN) unless due to Gilbert's disease
  • ALT/AST ≤ 2.5 times ULN, or < 5 times ULN for subjects with liver metastases
  • QT interval corrected for rate (QTc) ≤ 480 msec on the electrocardiogram (ECG) obtained at Screening
  • Negative serum pregnancy test within 14 days prior to the first dose of study therapy for women of child-bearing potential (WCBP), defined as a sexually mature woman who has not undergone a hysterectomy or who has not been naturally post-menopausal for at least 24 consecutive months (i.e., who has had menses any time in the preceding 24 consecutive months). Sexually active WCBP and male subjects must agree to use adequate methods to avoid pregnancy (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study and for 28 days after the completion of study treatment.
  • Ability to provide written informed consent

Exclusion Criteria:

  • Serious cardiac condition within the last 6 months, such as uncontrolled arrhythmia, myocardial infarction, unstable angina or heart disease defined by the New York Heart Association (NYHA) Class III or Class IV
  • Concomitant medication(s) that may cause QTc prolongation or induce Torsades de Pointes, with the exception of anti-microbials that are used as standard of care to prevent or treat infections and other such drugs that are considered by the Investigator to be essential for patient care
  • Active central nervous system (CNS) malignant disease in subjects with a history of CNS malignancy. Subjects with stable, prior or currently treated brain metastases are allowed.
  • Known positive for human immunodeficiency virus (HIV), hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV)
  • Active infection requiring intravenous (IV) antibiotic usage within the last week prior to study treatment
  • Any other medical intervention or other condition which, in the opinion of the Principal Investigator, could compromise adherence to study requirements or confound the interpretation of study results
  • Pregnant or breast-feeding
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 NCT02661542
Other Study ID Numbers  ICMJE FF-10502-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Fujifilm Pharmaceuticals U.S.A., Inc.
Study Sponsor  ICMJE Fujifilm Pharmaceuticals U.S.A., Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Filip Janku, MD University of Texas MD Anderson Center
Principal Investigator: Gerald Falchook, MD Sarah Cannon Research Institute-Denver
PRS Account Fujifilm Pharmaceuticals U.S.A., Inc.
Verification Date July 2020

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