Recruitment

Recruitment Status
Completed
Estimated Enrollment
36

Inclusion Criteria

absolute neutrophil count ≥ 1.5 x 10^9/L
platelets ≥ 100 x 10^9/L
bilirubin ≤ 1.5 x ULN
...
absolute neutrophil count ≥ 1.5 x 10^9/L
platelets ≥ 100 x 10^9/L
bilirubin ≤ 1.5 x ULN
Aged ≥ 18 years.
alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN (< 5 x ULN if documented hepatic metastases)
ECOG Performance Status of 0 or 1.
Signed informed consent prior to the start of any study specific procedures.
Patients must have pathologically-confirmed solid tumors, refractory after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available.
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
plasma creatinine ≤ 1.5 x upper limit of normal (ULN) for the institution
Patients may have measurable or non-measurable disease as defined by RECIST 1.1.

Exclusion Criteria

Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for non-cytotoxic agents prior to this study entry.
Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.
Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (aPTT) above the normal range (low dose deep vein thrombosis (DVT) or line prophylaxis is allowed).
...
Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for non-cytotoxic agents prior to this study entry.
Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.
Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (aPTT) above the normal range (low dose deep vein thrombosis (DVT) or line prophylaxis is allowed).
Pregnant or lactating individuals.
History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row), QTc ≥ 450 msec for men and 470 msec for women, or LVEF ≤ 40% by MUGA or ECHO.
Clinically evident central nervous system metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy; history of seizure disorder not controlled by anti-seizure medication at the time of enrollment.
Known allergy to fluoropyrimidines or known dihydropyrimidine dehydrogenase (DPD) deficiency.
Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
Documented or known bleeding disorder.
Cardiac dysfunction defined as myocardial infarction within 6 months of study entry, New York Heart Association Class III or IV heart failure, uncontrolled dysrhythmias or poorly controlled angina.
Current malignancies of another type, with the exception of adequately treated in situ cervical cancer, squamous cell and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
Known history of HIV, HBV or HCV infection.

Summary

Conditions
  • Cancer
  • Solid Tumors
Type
Interventional
Phase
Phase 1
Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

The Phase I dose escalation portion of the study has been completed. The maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) has been determined. The study will now evaluate the effect of food on the pharmacokinetics of DFP-11207. The food effect study is a two-step, two-way crossover desig...

The Phase I dose escalation portion of the study has been completed. The maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) has been determined. The study will now evaluate the effect of food on the pharmacokinetics of DFP-11207. The food effect study is a two-step, two-way crossover design to evaluate the pharmacokinetics and bioavailability of oral DFP-11207 capsules. During Cycle 1, oral DFP-11207 capsules are to be taken daily (as a single dose or twice-daily [approximately 12 hours apart]) under fed/fasted conditions. After Cycle 1, the food effect study will be completed and patients will continue to take oral DFP-11207 capsules twice-daily (approximately 12 hours apart) for 28 days of a 28-day treatment cycle.

Inclusion Criteria

absolute neutrophil count ≥ 1.5 x 10^9/L
platelets ≥ 100 x 10^9/L
bilirubin ≤ 1.5 x ULN
...
absolute neutrophil count ≥ 1.5 x 10^9/L
platelets ≥ 100 x 10^9/L
bilirubin ≤ 1.5 x ULN
Aged ≥ 18 years.
alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN (< 5 x ULN if documented hepatic metastases)
ECOG Performance Status of 0 or 1.
Signed informed consent prior to the start of any study specific procedures.
Patients must have pathologically-confirmed solid tumors, refractory after standard therapy for the disease or for which conventional systemic chemotherapy is not reliably effective or no effective therapy is available.
Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Women of child-bearing potential must have a negative serum or urine pregnancy test. Male and female patients must agree to use acceptable contraceptive methods for the duration of the study and for at least one month after the last drug administration.
plasma creatinine ≤ 1.5 x upper limit of normal (ULN) for the institution
Patients may have measurable or non-measurable disease as defined by RECIST 1.1.

Exclusion Criteria

Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for non-cytotoxic agents prior to this study entry.
Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.
Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (aPTT) above the normal range (low dose deep vein thrombosis (DVT) or line prophylaxis is allowed).
...
Patients will be excluded if they have received previous chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) or 5 half-lives for non-cytotoxic agents prior to this study entry.
Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.
Requirement for anticoagulation treatment that increases international normalized ratio (INR) or activated partial thromboplastin time (aPTT) above the normal range (low dose deep vein thrombosis (DVT) or line prophylaxis is allowed).
Pregnant or lactating individuals.
History of serious ventricular arrhythmia (VT or VF, ≥ 3 beats in a row), QTc ≥ 450 msec for men and 470 msec for women, or LVEF ≤ 40% by MUGA or ECHO.
Clinically evident central nervous system metastases or leptomeningeal disease not controlled by prior surgery or radiotherapy; history of seizure disorder not controlled by anti-seizure medication at the time of enrollment.
Known allergy to fluoropyrimidines or known dihydropyrimidine dehydrogenase (DPD) deficiency.
Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
Documented or known bleeding disorder.
Cardiac dysfunction defined as myocardial infarction within 6 months of study entry, New York Heart Association Class III or IV heart failure, uncontrolled dysrhythmias or poorly controlled angina.
Current malignancies of another type, with the exception of adequately treated in situ cervical cancer, squamous cell and basal cell skin cancer or other malignancies with no evidence of disease for 2 years or more.
Known history of HIV, HBV or HCV infection.

Tracking Information

NCT #
NCT02171221
Collaborators
Not Provided
Investigators
Not Provided
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