Advanced or Metastatic Solid Tumors in Patients With Hepatic ImpairmentPhase 1NCT01991678
A Study in Cancer Patients With Hepatic Impairment to Evaluate the Pharmacokinetics and Safety of NKTR-102 (Etirinotecan Pegol)
A Phase 1 study testing 145 mg/m2 NKTR 102, 120 mg/m2 NKTR 102 and 50 mg/m2 NKTR 102 in people with Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment, run by Nektar Therapeutics at 3 sites in United States.
Trial summary
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment
- What is being tested?
- 145 mg/m2 NKTR 102, 120 mg/m2 NKTR 102 and 50 mg/m2 NKTR 102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2013to Sep 2017
- 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
- Relapsed or progressive advanced solid tumor malignancies
- Measurable or non-measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy greater than 3 months
- Resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments
- Adequate bone morrow and kidney function
- No signs of decompensated liver cirrhosis or ascites requiring therapeutic paracentesis
- Agree to use adequate contraception
Who cannot join
- Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1
- Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1
- Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1
- UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1*37)
- Major surgery within 4 weeks prior to day 1
- Undergone a liver or other organ transplant
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- Concurrent treatment with other anti-cancer therapy
- Untreated central nervous system metastases
- Ongoing or active infection
- Chronic or acute GI disorders resulting in diarrhea
- Pregnancy or lactation
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University Hospitals Case-Medical Center Seidman Cancer Center
Cleveland, Ohio, 44106
USC/LA County
Los Angeles, California, 90089
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
About this study
Official title: An Open-Label, Parallel-Group, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics of NKTR-102 for Injection (Etirinotecan Pegol) in Patients With Advanced or Metastatic Solid Tumors and Hepatic Impairment
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.
Read the detailed description
Safety and PK data from patients with mild, moderate, or severe hepatic impairment will be compared with a control group consisting of patients with normal hepatic function.
- Being tested
- 145 mg/m2 NKTR 102, 120 mg/m2 NKTR 102, 50 mg/m2 NKTR 102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
145 mg/m2 NKTR 102Drug
120 mg/m2 NKTR 102Drug
50 mg/m2 NKTR 102Drug
| Study group | Role | What they receive |
|---|---|---|
| normal hepatic function | Experimental | 12 Patients will receive a 90-minute IV infusion Receives: Drug: 145 mg/m2 NKTR 102 |
| mild hepatic dysfunction | Experimental | 6 Patients will receive a 90-minute IV infusion Receives: Drug: 120 mg/m2 NKTR 102 |
| severe hepatic dysfunction | Experimental | 6 Patients will receive a 90-minute IV infusion Receives: Drug: 50 mg/m2 NKTR 102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK) of NKTR-102 and its metabolites
1 pre-dose PK measurements 14 post-dose PK measurements
Measured: Day 1 through Day 42
Secondary outcomes (1)
Safety and tolerability of NKTR-102
Assessments are: physical examinations, vital signs, ECGs, AEs, and laboratory testing.
Measured: Day 1 through Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionMay 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid Tumors in Patients With Hepatic ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nektar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivan Gergel, MD, Study director, Nektar Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01991678
- Sponsor's protocol ID
- 12-102-13
- Status last verified
- Oct 2017
- First submitted
- 29 Oct 2013
- Last updated
- 6 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Parallel-Group, Multicenter, Phase 1 Study to Investigate the Pharmacokinetics of NKTR-102 for Injection (Etirinotecan Pegol) in Patients With Advanced or Metastatic Solid Tumors and Hepatic Impairment
- ClinicalTrials.gov ID
- NCT01991678
- Acronym / sponsor ID
- 12-102-13
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Nov 2013 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 25 Nov 2013 (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.
The purpose of this study is to investigate the PK and safety of NKTR-102 in patients with mild, moderate, or severe hepatic impairment.
Detailed description
Safety and PK data from patients with mild, moderate, or severe hepatic impairment will be compared with a control group consisting of patients with normal hepatic function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| normal hepatic function | Experimental | Drug: 145 mg/m2 NKTR 10212 Patients will receive a 90-minute IV infusion |
| mild hepatic dysfunction | Experimental | Drug: 120 mg/m2 NKTR 1026 Patients will receive a 90-minute IV infusion |
| severe hepatic dysfunction | Experimental | Drug: 50 mg/m2 NKTR 1026 Patients will receive a 90-minute IV infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Relapsed or progressive advanced solid tumor malignancies
- Measurable or non-measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Life expectancy greater than 3 months
- Resolution of all acute toxic effects of prior chemotherapy, and other cancer treatments
Key exclusion criteria (11 listed)
- Previous chemotherapy, immunotherapy, chemo-embolization, targeted therapy or investigational agent for malignancy within 4 weeks prior to day 1
- Cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks prior to day 1
- Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1
- UGT1A1 genotype of TA 7 in both alleles (homozygous UGT1A1*28) or TA 8 in either one or both alleles (hetero- or homozygous for UGT1A1*37)
- Major surgery within 4 weeks prior to day 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 |
|---|---|---|
| 145 mg/m2 NKTR 102 | Drug | normal hepatic function |
| 120 mg/m2 NKTR 102 | Drug | mild hepatic dysfunction |
| 50 mg/m2 NKTR 102 | Drug | severe hepatic dysfunction |
Primary outcome
Pharmacokinetics (PK) of NKTR-102 and its metabolites
Time frame: Day 1 through Day 42
1 pre-dose PK measurements 14 post-dose PK measurements
1 secondary outcome
Safety and tolerability of NKTR-102
Time frame: Day 1 through Day 42
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 6 Oct 2017.
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.
Ivan Gergel, MD study director
Nektar Therapeutics
3 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 145 mg/m2 NKTR 102, 120 mg/m2 NKTR 102 and 50 mg/m2 NKTR 102 in people with Advanced or Metastatic Solid Tumors in Patients With Hepatic Impairment, run by Nektar Therapeutics at 3 sites 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 8 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 6 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Pharmacokinetics (PK) of NKTR-102 and its metabolites (time frame: Day 1 through Day 42). 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 6 Oct 2017.