Recurrent Small Cell Lung CarcinomaPhase 2NCT01876446
Pegylated Irinotecan NKTR 102 in Treating Patients With Relapsed Small Cell Lung Cancer
A Phase 2 study testing Laboratory Biomarker Analysis, Pegylated Irinotecan and Pharmacological Study in people with Recurrent Small Cell Lung Carcinoma, run by Roswell Park Cancer Institute at 3 sites in United States.
Trial summary
This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients with small cell lung cancer that has returned after a period of improvement. Pegylated irinotecan NKTR 102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Small Cell Lung Carcinoma
- What is being tested?
- Laboratory Biomarker Analysis, Pegylated Irinotecan and Pharmacological Study
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 3 sitesUnited States
- Study dates
- 29 Aug 2013to 24 Feb 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Written informed consent granted prior to initiation of any study-specific screening procedures, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- Histologic or cytologic diagnosis of SCLC (Note: patients with mixed histology are not eligible)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Presence of measurable disease defined as >= 1 lesion whose longest diameter can be accurately measured as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT)
- Previously treated SCLC with only one prior treatment regimen (cyclophosphamide/doxorubicin/vincristine [CAV] alternating with etoposide/cisplatin [EP] is acceptable)
- Resolution of all acute toxic effects of prior chemotherapy, radiotherapy, hormonal therapy, or surgery to National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 grade =< 1, except for diarrhea (which must be grade 0 without supportive antidiarrheal medications) and alopecia (any grade)
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- Platelet count >= 100 x 10^9/L
- Hemoglobin (Hgb) >= 9 gm/dL
- Absolute neutrophil count (ANC) >= 1500/uL
- Serum creatinine =< 1.5 mg/dL or creatinine clearance > 45 mL/min; use either measured or calculated with Cockcroft-Gault formula
- Serum total bilirubin =< 1.5 x upper limit of normal (ULN)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 3 x ULN or =< 5 x ULN if caused by liver metastasis
- Women of childbearing potential must have a negative pregnancy test performed within seven days prior to the start of study drug; male and female subjects of child-bearing potential must agree to use double-barrier contraceptive measures, or avoidance of intercourse during the study and for 6 months after last investigational drug dose received
Who cannot join
- Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first day of study defined treatment; palliative radiation < 2 weeks, biological therapy within 2 weeks, hormonal therapy within 1 week prior to day 1 cycle 1
- Prior treatment with a topoisomerase-I inhibitor (e.g., topotecan, irinotecan)
- Prior malignancy except for non-melanoma skin cancer and carcinoma in situ, unless diagnosed and definitively treated more than 5 years prior to enrollment
- Substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results
- Known human immunodeficiency virus (HIV) infection
- Pregnancy or breast-feeding
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- Concurrent administration or received cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers or inhibitors within 2 weeks prior to the first day of study drug treatment
- Patients with chronic or acute gastrointestinal (GI) disorders resulting in diarrhea of any severity grade; patients who are using chronic anti-diarrheal supportive care (more than 3 days/week) to control diarrhea in the 28 days prior to study entry
- Major surgery < 4 weeks or minor surgery (e.g. talc pleurodesis, excisional biopsy, etc) < 2 weeks prior to the first day of study defined treatment
- Have central nervous system (CNS) metastases (unless the patient has completed successful local therapy for CNS metastases and has been off corticosteroids for at least 4 weeks before starting study therapy); brain imaging is required in symptomatic patients to rule out brain metastases, but is not required in asymptomatic patients
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Unwilling or unable to follow protocol requirements
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
Rochester General Hospital
Rochester, New York, 14621
Linden Oaks Medical Campus
Rochester, New York, 14625
About this study
Official title: A Phase II Study of Single Agent Topoisomerase-I Inhibitor Polymer Conjugate, Etirinotecan Pegol (NKTR-102), in Patients With Relapsed Small Cell Lung Cancer
This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients with small cell lung cancer that has returned after a period of improvement. Pegylated irinotecan NKTR 102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the 18-week progression free survival (PFS) rate of relapsed small cell lung cancer (SCLC) patients treated with NKTR-102 (pegylated irinotecan NKTR 102).
SECONDARY OBJECTIVES:
- To evaluate the objective response rate. II. To evaluate the duration of response. III. To evaluate the overall survival. IV. To evaluate the toxicity of NKTR-102 in this patient population.
TERTIARY OBJECTIVES:
- To explore the correlation between UDP glucuronosyltransferase 1 family, polypeptide A cluster (UGTIA1) polymorphisms and NKTR-102 toxicities.
OUTLINE:
Patients receive pegylated irinotecan NKTR 102 intravenously (IV) over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
- Conditions
- Recurrent Small Cell Lung Carcinoma
- Being tested
- Laboratory Biomarker Analysis, Pegylated Irinotecan, Pharmacological Study
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laboratory Biomarker AnalysisOther
Correlative studies
Pegylated IrinotecanDrug
Also called NKTR 102, PEG-Irinotecan
Given IV
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (pegylated irinotecan NKTR 102) | Experimental | Patients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity Receives: Other: Laboratory Biomarker Analysis; Drug: Pegylated Irinotecan; Other: Pharmacological Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
18 Week Progression-free Survival Rate
The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.
Measured: Time from registration to the date of first documented disease progression or death, assessed at 18 weeks
Secondary outcomes (5)
Objective Tumor Response Measured With Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Objective tumor response will be tabulated overall (and by dose level if appropriate). Responses will be summarized by simple descriptive summary statistics delineating complete and partial responses as well as stable and progressive disease in the cohorts (overall and by tumor group).
Measured: Up to 30 days
Mean Duration of Response
The mean duration of response for those participants that responded to treatment by arm.
Measured: Time from registration to death due to any cause, assessed up to 3 years
Best Response
Count of participants by best response, defined as best objective status recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since treatment started), measured by RECIST 1.1
Tumor response is defined as a complete response (CR) or partial response (PR) by RECIST 1.1 criteria, which will be evaluated by CT scan every other cycle. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Measured: Up to 30 days
Median Overall Survival
The distribution of survival time was be estimated in each group using the method of Kaplan-Meier.
Measured: Time from registration to death due to any cause, assessed up to 3 years
Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0
Count of participants by maximum graded according to NCI CTCAE v 4.0 of any adverse event by arm.
Please refer to the adverse event reporting for more detail.
Measured: Up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2013 (estimated)
- Study start29 Aug 2013
- Primary completion18 Jul 2017
- Study completion24 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Recurrent Small Cell Lung CarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Nektar Therapeutics
- Responsible party
- Sponsor
- Investigators
- Hongbin Chen, MD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01876446
- Sponsor's protocol ID
- I 225612
- Other IDs
- NCI-2013-01142, I 225612, P30CA016056
- Status last verified
- Mar 2020
- First submitted
- 10 Jun 2013
- Last updated
- 17 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Single Agent Topoisomerase-I Inhibitor Polymer Conjugate, Etirinotecan Pegol (NKTR-102), in Patients With Relapsed Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT01876446
- Acronym / sponsor ID
- I 225612
- Conditions
- Recurrent Small Cell Lung Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Nektar Therapeutics
- Study start
- 29 Aug 2013 (actual)
- Primary completion
- 18 Jul 2017 (actual)
- Study completion
- 24 Feb 2020 (actual)
- First posted
- 12 Jun 2013 (estimated)
- Results
- Posted 6 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well pegylated irinotecan NKTR 102 works in treating patients with small cell lung cancer that has returned after a period of improvement. Pegylated irinotecan NKTR 102 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the 18-week progression free survival (PFS) rate of relapsed small cell lung cancer (SCLC) patients treated with NKTR-102 (pegylated irinotecan NKTR 102).
SECONDARY OBJECTIVES:
- To evaluate the objective response rate. II. To evaluate the duration of response. III. To evaluate the overall survival. IV. To evaluate the toxicity of NKTR-102 in this patient population.
TERTIARY OBJECTIVES:
- To explore the correlation between UDP glucuronosyltransferase 1 family, polypeptide A cluster (UGTIA1) polymorphisms and NKTR-102 toxicities.
OUTLINE:
Patients receive pegylated irinotecan NKTR 102 intravenously (IV) over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (pegylated irinotecan NKTR 102) | Experimental | Other: Laboratory Biomarker Analysis, Drug: Pegylated Irinotecan, Other: Pharmacological StudyPatients receive pegylated irinotecan NKTR 102 IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent granted prior to initiation of any study-specific screening procedures, given with the understanding that the patient has the right to withdraw from the study at any time, without prejudice
- Histologic or cytologic diagnosis of SCLC (Note: patients with mixed histology are not eligible)
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Presence of measurable disease defined as >= 1 lesion whose longest diameter can be accurately measured as >= 20 mm with conventional techniques or as >= 10 mm with spiral computed tomography (CT)
- Previously treated SCLC with only one prior treatment regimen (cyclophosphamide/doxorubicin/vincristine [CAV] alternating with etoposide/cisplatin [EP] is acceptable)
Key exclusion criteria (12 listed)
- Previous anti-cancer chemotherapy, immunotherapy or investigational agents < 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to the first day of study defined treatment; palliative radiation < 2 weeks, biological therapy within 2 weeks, hormonal therapy within 1 week prior to day 1 cycle 1
- Prior treatment with a topoisomerase-I inhibitor (e.g., topotecan, irinotecan)
- Prior malignancy except for non-melanoma skin cancer and carcinoma in situ, unless diagnosed and definitively treated more than 5 years prior to enrollment
- Substance abuse, medical, psychological or social conditions that may, in the opinion of the Investigator, interfere with the patient's participation in the study or evaluation of the study results
- Known human immunodeficiency virus (HIV) infection
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 |
|---|---|---|
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (pegylated irinotecan NKTR 102) |
| Pegylated IrinotecanAlso: NKTR 102, PEG-IrinotecanGiven IV | Drug | Treatment (pegylated irinotecan NKTR 102) |
| Pharmacological StudyCorrelative studies | Other | Treatment (pegylated irinotecan NKTR 102) |
Primary outcome
18 Week Progression-free Survival Rate
Time frame: Time from registration to the date of first documented disease progression or death, assessed at 18 weeks
The distribution of time to disease progression will be estimated in each group using the method of Kaplan-Meier at 18 weeks.
5 secondary outcomes
Objective Tumor Response Measured With Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Up to 30 days
Mean Duration of Response
Time frame: Time from registration to death due to any cause, assessed up to 3 years
Best Response
Time frame: Up to 30 days
Median Overall Survival
Time frame: Time from registration to death due to any cause, assessed up to 3 years
Incidence of Adverse Events, Assessed Using NCI CTCAE v 4.0
Time frame: Up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Hongbin Chen, MD principal investigator
Roswell Park Cancer Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Laboratory Biomarker Analysis, Pegylated Irinotecan and Pharmacological Study in people with Recurrent Small Cell Lung Carcinoma, run by Roswell Park Cancer Institute 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 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 17 Mar 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
18 Week Progression-free Survival Rate (time frame: Time from registration to the date of first documented disease progression or death, assessed at 18 weeks). 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 17 Mar 2020.