Solid TumorsPhase 1NCT02171221
Phase I Study of Oral DFP-11207 in Solid Tumors
A Phase 1 study testing Oral DFP-11207 in people with Solid Tumors and Cancer, run by Delta-Fly Pharma, Inc. at 1 site in United States.
Trial summary
This is a first-in-human, open label, single arm, sequential dose escalation and expansion study of oral DFP-11207 in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumors, Cancer
- What is being tested?
- Oral DFP-11207
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2014to 13 Sep 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Aged ≥ 18 years.
- ECOG Performance Status of 0 or 1.
- Adequate clinical laboratory values defined as:
- absolute neutrophil count ≥ 1.5 x 10^9/L
- platelets ≥ 100 x 10^9/L
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- plasma creatinine ≤ 1.5 x upper limit of normal (ULN) for the institution
- bilirubin ≤ 1.5 x ULN
- alanine transaminase (ALT) and aspartate transaminase (AST) < 2.5 x ULN (< 5 x ULN if documented hepatic metastases)
- Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
- Patients may have measurable or non-measurable disease as defined by RECIST 1.1.
- Signed informed consent prior to the start of any study specific procedures.
- 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.
Who cannot join
- Known allergy to fluoropyrimidines or known dihydropyrimidine dehydrogenase (DPD) deficiency.
- 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.
- Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
- Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.
- Pregnant or lactating individuals.
- 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.
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- Known history of HIV, HBV or HCV infection.
- Documented or known bleeding disorder.
- 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).
- 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Once-Daily Oral DFP-11207 in Patients With Solid Tumors
This is a first-in-human, open label, single arm, sequential dose escalation and expansion study of oral DFP-11207 in patients with advanced solid tumors.
Read the detailed 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 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.
- Conditions
- Solid Tumors, Cancer
- Being tested
- Oral DFP-11207
- Keywords
- Refractory or relapsed tumors, Antimetabolites, Antineoplastic, Fluorouracil
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral DFP-11207Drug
| Study group | Role | What they receive |
|---|---|---|
| Oral DFP-11207 | Experimental | DFP-11207: daily oral dosing, 28 day treatment cycle Receives: Drug: Oral DFP-11207 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of daily oral dosing of DFP-11207 in patients with solid tumors
The MTD and tolerability will be based on the incidence of adverse events and dose-limiting toxicities in patients. CTCAE 4.0 will be used to grade the severity of adverse events.
Measured: Continuous starting on day of first dose (Day 1) up to 30 days after last dose
For food effect study: To assess PK profiles of DFP-11207 under fed and fasted conditions
Plasma concentration and time data of DFP-11207 metabolites for the food effect study will be determined.
Measured: Cycle 1, Day 1: pre dose, 4, 10, 24, and 48 hrs post-dose; Day 14: 2, 10 and 24 hrs post-dose; Day 16: pre-dose, 4, 10, and 24 hrs post-dose; Day 18: pre-dose; Day 23: 2 hrs post-dose; Day 29: 2 and 24 hrs post-dose. Cycle 2, Day 1: pre-dose
Secondary outcomes (2)
Pharmacokinetics (PK): To measure plasma and urine concentrations of DFP-11207 and its metabolites
PK parameters to be measured include area under the concentration curve versus time (AUC) and maximum drug concentration (Cmax)
Measured: Cycle 1, Day 1: 1, 2, 4, 8, 12, 24 and 48 hours post-dose; and on Days 15 and 29
To determine preliminary efficacy (overall response rate) in solid tumor patients receiving oral DFP-11207
Response to treatment will be assessed per RECIST 1.1
Measured: Every 8 weeks (2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJun 2014
- Primary completion13 Sep 2018
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Delta-Fly Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02171221
- Sponsor's protocol ID
- D13-11038
- Status last verified
- Jan 2019
- First submitted
- 19 Jun 2014
- Last updated
- 29 Jan 2019
- Results posted
- No
Publications
Ajani JA, Javle M, Eng C, Fogelman D, Smith J, Anderson B, Zhang C, Iizuka K. Phase I study of DFP-11207, a novel oral fluoropyrimidine with reasonable AUC and low Cmax and improved tolerability, in patients with solid tumors. Invest New Drugs. 2020 Dec;38(6):1763-1773. doi: 10.1007/s10637-020-00939-w. Epub 2020 May 6.
PubMed 32377978
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Once-Daily Oral DFP-11207 in Patients With Solid Tumors
- ClinicalTrials.gov ID
- NCT02171221
- Acronym / sponsor ID
- D13-11038
- Conditions
- Solid Tumors, Cancer
- Keywords
- Refractory or relapsed tumors, Antimetabolites, Antineoplastic, Fluorouracil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Delta-Fly Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- 13 Sep 2018 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a first-in-human, open label, single arm, sequential dose escalation and expansion study of oral DFP-11207 in patients with advanced solid tumors.
Detailed 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral DFP-11207 | Experimental | Drug: Oral DFP-11207DFP-11207: daily oral dosing, 28 day treatment cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- Aged ≥ 18 years.
- ECOG Performance Status of 0 or 1.
- Adequate clinical laboratory values defined as:
- Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
Key exclusion criteria (12 listed)
- Known allergy to fluoropyrimidines or known dihydropyrimidine dehydrogenase (DPD) deficiency.
- 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.
- Extensive prior radiotherapy, more than 30% of bone marrow reserves, or prior bone marrow/stem cell transplantation.
- Any concomitant condition that in the opinion of the Investigator could compromise the objectives of this study and the patient's compliance.
- Pregnant or lactating individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral DFP-11207 | Drug | Oral DFP-11207 |
Primary outcome
To determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of daily oral dosing of DFP-11207 in patients with solid tumors
Time frame: Continuous starting on day of first dose (Day 1) up to 30 days after last dose
The MTD and tolerability will be based on the incidence of adverse events and dose-limiting toxicities in patients. CTCAE 4.0 will be used to grade the severity of adverse events.
For food effect study: To assess PK profiles of DFP-11207 under fed and fasted conditions
Time frame: Cycle 1, Day 1: pre dose, 4, 10, 24, and 48 hrs post-dose; Day 14: 2, 10 and 24 hrs post-dose; Day 16: pre-dose, 4, 10, and 24 hrs post-dose; Day 18: pre-dose; Day 23: 2 hrs post-dose; Day 29: 2 and 24 hrs post-dose. Cycle 2, Day 1: pre-dose
Plasma concentration and time data of DFP-11207 metabolites for the food effect study will be determined.
2 secondary outcomes
Pharmacokinetics (PK): To measure plasma and urine concentrations of DFP-11207 and its metabolites
Time frame: Cycle 1, Day 1: 1, 2, 4, 8, 12, 24 and 48 hours post-dose; and on Days 15 and 29
To determine preliminary efficacy (overall response rate) in solid tumor patients receiving oral DFP-11207
Time frame: Every 8 weeks (2 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
- Derived from this study: PubMed 32377978Ajani JA, Javle M, Eng C, Fogelman D, Smith J, Anderson B, Zhang C, Iizuka K. Phase I study of DFP-11207, a novel oral fluoropyrimidine with reasonable AUC and low Cmax and improved tolerability, in patients with solid tumors. Invest New Drugs. 2020 Dec;38(6):1763-1773. doi: 10.1007/s10637-020-00939-w. Epub 2020 May 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral DFP-11207 in people with Solid Tumors and Cancer, run by Delta-Fly Pharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the maximum tolerated dose (MTD) and to evaluate the safety and tolerability of daily oral dosing of DFP-11207 in patients with solid tumors (time frame: Continuous starting on day of first dose (Day 1) up to 30 days after last dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02171221, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2019; AzTrials last refreshed its copy on 6 Nov 2026.