Study of FF-10502-01 in Patients With Advanced Solid Tumors and Lymphomas

Solid Tumors Clinical Trial

Official title:

A Phase 1/2a, Dose-escalation Study of FF-10502-01 for the Treatment of Advanced Solid Tumors and Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02661542
• Other study ID #: FF1050201US101
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2016
• Est. completion date: November 5, 2020

Study information

• Verified date: April 2022
• Source: Fujifilm Pharmaceuticals U.S.A., Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: November 5, 2020
• Est. primary completion date: November 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphomas
• Solid Tumors

Intervention

Drug:
• FF-10502-01

Locations

Country	Name	City	State
United States	Sarah Cannon Research Institute at HealthOne	Denver	Colorado
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Fujifilm Pharmaceuticals U.S.A., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment Emergent Adverse Events (Safety and Tolerability)	Safety and tolerability assessed by adverse events (AEs), and serious adverse events. (SAEs)	33 Months
Secondary	Determination of overall response rates	Determination of overall response rates	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).
Secondary	Determination of duration of response.	duration of response is determined	Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug
Secondary	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.	measurement of stable disease	Assessed at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug
Secondary	Evaluate progression-free survival (PFS)	measurement of PFS	Responses and survival assessed, at the end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug
Secondary	Evaluate overall survival (OS)	measurement of OSS	Assessed by telephone call at end of C2 and every 2 cycles thereafter through 6 months following last dose of study drug
Secondary	Evaluate the mean plasma concentrations of FF-10502-01	measurement of plasma concentrations	Assessed at Cycle 1 Day 1, and Cycle 1 Day 15
Secondary	Evaluate FF-10502-01 incorporation into whole blood cellular DNA by LC-MS/MS as a pharmacodynamic marker	measurement of cellular DNA	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.