Refractory Solid TumorsPhase 1NCT03810742
Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
A Phase 1 study testing Nanoliposomal Irinotecan in people with Refractory Solid Tumors, run by PharmaEngine at 2 sites in Taiwan.
Trial summary
The study is to explore the combination of nal-IRI and TAS-102, which is expected to be an effective regimen that could be applied to various cancers Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Refractory Solid Tumors
- What is being tested?
- Nanoliposomal Irinotecan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesTaiwan
- Study dates
- 5 Mar 2019to 25 Oct 2023
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ages between 20 to 70 years old
- Histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed standard treatment or have no standard treatment currently available
- ECOG performance status 0 or 1
- Normal ECG or ECG without any clinically significant findings
- Adequate hematologic parameters, and hepatic and renal function i. White blood cell (WBC) count 3000/μL and absolute neutrophil count (ANC) 1500/μL ii. Platelet counts 100,000/μL without platelet transfusion within 14 days iii. Hemoglobin level 10 g/dL iv. Serum total bilirubin- within normal range v. Serum albumin 3.0 g/dL vi. Serum alanine aminotransferase (ALT) 3 x the upper limit of normal (ULN) vii. Serum creatinine 1.5 x ULN
Who cannot join
- Received prior nal-IRI (ONIVYDE®) or TAS-102 (LONSURF®) therapy
- Known hypersensitivity to any of the components of nal-IRI, other liposomal products, fluoropyrimidines or leucovorin
- Have liver cirrhosis with Child-Pugh B or Child-Pugh C
- With active CNS metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
- With clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
- Life expectancy of less than 3 months
Show all 11Show fewer
- Use any anti-cancer or investigational product within 14 days prior to the first date of study dosing
- History of any second malignancy in the latest 5 years except curatively treated non-melanoma skin cancer or treated cervical carcinoma in situ
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection requiring antibiotic treatment, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia, and psychiatric illness or social situation that would preclude study compliance
- Homozygous for the UGT1A1 28 allele (TA7/TA7), homozygous for UGT1A1 6 allele (A/A), or double heterozygous for both UGT1A1 28 allele (TA6/TA7) and UGT1A1 6 allele (G/A) (only for dose-finding phase)
- Pregnant or breastfeeding women
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
China Medical University Hospital
Taichung
National Cheng Kung University Hospital
Tainan
About this study
Official title: Phase 1 Study of Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
The study is to explore the combination of nal-IRI and TAS-102, which is expected to be an effective regimen that could be applied to various cancers
Read the detailed description
Primary Objectives
- to determine the maximum tolerated dose (MTD) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)
- to evaluate the toxicity profile of the combination therapy Secondary Objectives
- to evaluate the preliminary efficacy of the combination therapy of nal-IRI (ONIVYDE®) and TAS-102 (LONSURF®)
- to study the pharmacokinetics of the combination therapy
A phase 1 study with a classical 3 + 3 dose escalation design. The target population is patients who have pathologically confirmed malignant solid tumors with no standard treatment available.
- Conditions
- Refractory Solid Tumors
- Being tested
- Nanoliposomal Irinotecan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nanoliposomal IrinotecanDrug
Also called TAS-102
Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)
| Study group | Role | What they receive |
|---|---|---|
| Nanoliposomal Irinotecan + TAS-102 | Experimental | different dosage combination by Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®) Receives: Drug: Nanoliposomal Irinotecan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of Dose Limiting Toxicities (DLT)
to find the Dose Limiting Toxicity (DLT) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)
Measured: 12 months
Evaluation of Safety profile of nal-IRI and TAS-102 - Incidence of Treatment-Emergent Adverse Events
Incidence of Treatment-Emergent Adverse Events [Safety] of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) according to NCI-CTCAE version 5.0
Measured: 12 months
Secondary outcomes (7)
Evaluation of objective tumor response as per Response Evaluation Criteria in Solid Tumors (RECIST)
the objective tumor rate by using RECIST v1.1
Measured: 24 months
Pharmacokinetics study - (Cmax)
Concentration of Peak Plasma (Cmax)
Measured: 6 months
Pharmacokinetics study - (Tmax)
maximum concentration of the time taken to reach the (Tmax).
Measured: 6 months
Pharmacokinetics study - (T1/2)
time of C max to drop in half taken (T1/2)
Measured: 6 months
Pharmacokinetics study - (AUC0→t)
area of the plasma concentration versus time curve (AUC0→t).
Measured: 6 months
Pharmacokinetics study - (AUC0→∞)
area of the plasma concentration versus under curve (AUC0→∞)
Measured: 6 months
Pharmacokinetics study - (CL)
rate of clearance (CL)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2019
- Study start5 Mar 2019
- Primary completion4 May 2022
- Study completion25 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEngine
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chia-Chi Lin, MD, Principal investigator, National Taiwan University Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810742
- Sponsor's protocol ID
- PEP0210
- Status last verified
- Nov 2023
- First submitted
- 21 Dec 2018
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Nanoliposomal Irinotecan (Nal-IRI, ONIVYDE®) in Combination With TAS-102 (LONSURF®) in Refractory Solid Tumors
- ClinicalTrials.gov ID
- NCT03810742
- Acronym / sponsor ID
- PEP0210
- Conditions
- Refractory Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- PharmaEngineIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 25 Oct 2023 (actual)
- First posted
- 22 Jan 2019 (actual)
- 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.
The study is to explore the combination of nal-IRI and TAS-102, which is expected to be an effective regimen that could be applied to various cancers
Detailed description
Primary Objectives
- to determine the maximum tolerated dose (MTD) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)
- to evaluate the toxicity profile of the combination therapy Secondary Objectives
- to evaluate the preliminary efficacy of the combination therapy of nal-IRI (ONIVYDE®) and TAS-102 (LONSURF®)
- to study the pharmacokinetics of the combination therapy
A phase 1 study with a classical 3 + 3 dose escalation design. The target population is patients who have pathologically confirmed malignant solid tumors with no standard treatment available.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nanoliposomal Irinotecan + TAS-102 | Experimental | Drug: Nanoliposomal Irinotecandifferent dosage combination by Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ages between 20 to 70 years old
- Histologically or cytologically confirmed malignant solid tumors which are advanced or metastatic, have failed standard treatment or have no standard treatment currently available
- ECOG performance status 0 or 1
- Normal ECG or ECG without any clinically significant findings
- Adequate hematologic parameters, and hepatic and renal function i. White blood cell (WBC) count 3000/μL and absolute neutrophil count (ANC) 1500/μL ii. Platelet counts 100,000/μL without platelet transfusion within 14 days iii. Hemoglobin level 10 g/dL iv. Serum total bilirubin- within normal range v. Serum albumin 3.0 g/dL vi. Serum alanine aminotransferase (ALT) 3 x the upper limit of normal (ULN) vii. Serum creatinine 1.5 x ULN
Key exclusion criteria (11 listed)
- Received prior nal-IRI (ONIVYDE®) or TAS-102 (LONSURF®) therapy
- Known hypersensitivity to any of the components of nal-IRI, other liposomal products, fluoropyrimidines or leucovorin
- Have liver cirrhosis with Child-Pugh B or Child-Pugh C
- With active CNS metastasis (indicated by clinical symptoms, cerebral edema, steroid requirement, or progressive growth)
- With clinically significant gastrointestinal disorder including hepatic disorders, bleeding, inflammation, occlusion, or diarrhea > grade 1
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 |
|---|---|---|
| Nanoliposomal IrinotecanAlso: TAS-102Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®) | Drug | Nanoliposomal Irinotecan + TAS-102 |
Primary outcome
Determination of Dose Limiting Toxicities (DLT)
Time frame: 12 months
to find the Dose Limiting Toxicity (DLT) of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®)
Evaluation of Safety profile of nal-IRI and TAS-102 - Incidence of Treatment-Emergent Adverse Events
Time frame: 12 months
Incidence of Treatment-Emergent Adverse Events [Safety] of nal-IRI (ONIVYDE®) in combination with TAS-102 (LONSURF®) according to NCI-CTCAE version 5.0
7 secondary outcomes
Evaluation of objective tumor response as per Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: 24 months
Pharmacokinetics study - (Cmax)
Time frame: 6 months
Pharmacokinetics study - (Tmax)
Time frame: 6 months
Pharmacokinetics study - (T1/2)
Time frame: 6 months
Pharmacokinetics study - (AUC0→t)
Time frame: 6 months
Pharmacokinetics study - (AUC0→∞)
Time frame: 6 months
Pharmacokinetics study - (CL)
Time frame: 6 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 18 Nov 2023.
- Individual participant dataSharing planned: No
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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.
Chia-Chi Lin, MD principal investigator
National Taiwan University Hospital, Taipei, Taiwan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nanoliposomal Irinotecan in people with Refractory Solid Tumors, run by PharmaEngine at 2 sites in Taiwan.
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 5 inclusion and 11 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. 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?
Determination of Dose Limiting Toxicities (DLT) (time frame: 12 months). 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?
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 18 Nov 2023.