Advanced CancerPhase 1NCT01976143
A Study in Cancer Patients to Evaluate the Effect of a Single Dose of NKTR-102 (Etirinotecan Pegol) on the QTc Interval and to Assess Pharmacokinetics and Safety
A Phase 1 study testing NKTR-102 in people with Advanced Cancer and Metastatic Solid Tumors, run by Nektar Therapeutics at 3 sites in United States.
Trial summary
The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc interval in patients with advanced or metastatic solid tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cancer, Metastatic Solid Tumors
- What is being tested?
- NKTR-102
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2014to Sep 2016
- 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
- Advanced or metastatic solid tumor refractory to standard therapy
- Measurable or non-measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Resolution of acute toxic effects of prior chemotherapy and other cancer treatments
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram
- Adequate bone morrow and organ function
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- Electrolytes within normal limits
- Stopped tobacco use for 4 weeks prior to day 1 and during the study
- Agree to use adequate contraception
Who cannot join
- Previous anti-cancer therapy for malignancy within 4 weeks (6 weeks for the nitrosoureas or mitomycin C) before day 1
- Treatment with antiarrythmic drugs and any medication known to cause QTc prolongation within 4 weeks before screening and during the study
- Prior extensive anthracycline exposure
- Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before day 1 and during the study
- Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 and during the study
- History of serious cardiovascular disease
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- Abnormal systolic blood pressure, diastolic blood pressure and/or heart rate
- History of additional risk factors for Torsade de Pointes
- Prolonged QTcF
- Important abnormalities of the ECG that may interfere with the interpretation of QTc interval changes at screening
- Implantable pacemaker or automatic implantable cardioverter defibrillator
- 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)
- Any major surgery within 4 weeks prior to day 1
- Concurrent treatment with other anticancer therapy
- Untreated central nervous system metastases
- 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
American Institute of Research, Los Angeles
Los Angeles, California, 90017
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
About this study
Official title: A Phase 1 Study to Evaluate the Effect of Nktr-102 for Injection (Etirinotecan Pegol) on the QT/QTC Interval in Patients With Advanced or Metastatic Solid Tumors
The purpose of this research study is to evaluate the effect of NKTR-102 on the QT/QTc interval in patients with advanced or metastatic solid tumors
Read the detailed description
This is an open-label study that will assess the effect of NKTR- 102 on cardiac ventricular repolarization, as characterized by QTcF (QT interval with Fridericia correction) interval values, in patients with advanced or metastatic solid tumors following administration of a single dose of NKTR-102.
- Conditions
- Advanced Cancer, Metastatic Solid Tumors
- Being tested
- NKTR-102
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NKTR-102Drug
| Study group | Role | What they receive |
|---|---|---|
| NKTR-102 | Experimental | A single 90 minute IV infusion of 220 mg/m2 NKTR-102 Receives: Drug: NKTR-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTcF interval values
10 pre-dose and 18 post-dose ECG measurements to evaluate the effect of NKTR-102
Measured: Day -1 through Day 42
Secondary outcomes (1)
Pharmacokinetics (PK) and ECG Parameters
1 pre-dose and 18 post-dose blood samples to measure concentrations of NKTR-102 and its metabolites
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 posted5 Nov 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies 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
- 33 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
- NCT01976143
- Sponsor's protocol ID
- 12-102-12
- Status last verified
- Dec 2016
- First submitted
- 29 Oct 2013
- Last updated
- 22 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Effect of Nktr-102 for Injection (Etirinotecan Pegol) on the QT/QTC Interval in Patients With Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT01976143
- Acronym / sponsor ID
- 12-102-12
- Conditions
- Advanced Cancer, Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Nektar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 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 research study is to evaluate the effect of NKTR-102 on the QT/QTc interval in patients with advanced or metastatic solid tumors
Detailed description
This is an open-label study that will assess the effect of NKTR- 102 on cardiac ventricular repolarization, as characterized by QTcF (QT interval with Fridericia correction) interval values, in patients with advanced or metastatic solid tumors following administration of a single dose of NKTR-102.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NKTR-102 | Experimental | Drug: NKTR-102A single 90 minute IV infusion of 220 mg/m2 NKTR-102 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Advanced or metastatic solid tumor refractory to standard therapy
- Measurable or non-measurable disease
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Resolution of acute toxic effects of prior chemotherapy and other cancer treatments
- Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram
Key exclusion criteria (17 listed)
- Previous anti-cancer therapy for malignancy within 4 weeks (6 weeks for the nitrosoureas or mitomycin C) before day 1
- Treatment with antiarrythmic drugs and any medication known to cause QTc prolongation within 4 weeks before screening and during the study
- Prior extensive anthracycline exposure
- Administration of cytochrome P450 CYP3A4 inducers and inhibitors within 4 weeks before day 1 and during the study
- Intake of grapefruit, grapefruit juice, Seville oranges, or other products containing grapefruit or Seville oranges within 14 days prior to day 1 and during the study
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 |
|---|---|---|
| NKTR-102 | Drug | NKTR-102 |
Primary outcome
QTcF interval values
Time frame: Day -1 through Day 42
10 pre-dose and 18 post-dose ECG measurements to evaluate the effect of NKTR-102
1 secondary outcome
Pharmacokinetics (PK) and ECG Parameters
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 22 Dec 2016.
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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.
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 NKTR-102 in people with Advanced Cancer and Metastatic Solid Tumors, 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 9 inclusion and 17 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 22 Dec 2016. 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?
QTcF interval values (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 22 Dec 2016.