Neoplasms, OvarianPhase 1NCT00659178
Combination Study Of SB-485232 (Interleukin 18) And Doxil For Advanced Stage Epithelial Ovarian Cancer
A Phase 1 study testing SB-485232 (interleukin 18), pegylated liposomal doxorubicin in people with Neoplasms, Ovarian, run by GlaxoSmithKline at 3 sites in United States.
Trial summary
The purpose of this study is to identify a dose of SB-485232 which is safe, tolerable and biologically active when used in combination with pegylated liposomal doxorubicin (Doxil) in patients with epithelial ovarian cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Neoplasms, Ovarian
- What is being tested?
- SB-485232 (interleukin 18), pegylated liposomal doxorubicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 18 Jun 2008to 18 Feb 2011
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female, age ≥18 years of age;
- Histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma;
- Candidate to receive pegylated liposomal doxorubicin for treatment of advanced stage ovarian cancer as per standard of care and in the opinion of the treating principal investigator;
- Measurable lesion(s) according to RECIST v1.0;
- ECOG performance status of 0, 1 or 2;
- Predicted life expectancy of ≥4 months
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- No chemotherapy, immunotherapy, hormonal therapy, or biological therapy for cancer, radiotherapy, or surgical procedures (except for minor surgical procedures) within four weeks before beginning treatment with SB-485232 (six weeks for nitrosoureas and mitomycin C). Subjects must have recovered from toxicities (incurred as a result of previous therapy) sufficiently to be entered into a Phase I study;
- Disease-free period of at least five years from prior malignancies (except for curatively treated basal and squamous cell carcinomas of the skin and/or carcinoma of the cervix in situ);
- Left ventricular ejection fraction (LVEF) ≥50 % as determined by MUGA scan;
- A signed and dated written informed consent form is obtained from the subject;
- The subject is able to understand and comply with protocol requirements, timetables, instructions and protocol-stated restrictions;
- The subject is likely to maintain good venous blood access for PK and PD sampling throughout the study;
- A female is eligible to enter and participate in the study if she is of: non-childbearing potential (i.e., physiologically incapable of becoming pregnant) or, childbearing potential, has a negative serum pregnancy test at the screening visit, and agrees to one of several GSK acceptable contraceptive methods;
- Adequate organ function defined as: ANC ≥1.5 x 10^9/L; hemoglobin ≥9 g/dL (after transfusion if needed); platelets ≥75 x 10^9/L.
Who cannot join
- Significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or autoimmune conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial;
- Any severe concurrent disease or condition, including significant active autoimmune diseases such as rheumatoid arthritis, which in the judgment of the principal investigator, would make the subject inappropriate for study participation;
- History of myocardial infarction, unstable angina, or acute coronary syndrome within the past six months;
- The subject has a history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of pegylated liposomal doxorubicin;
- The subject has a history of receiving a total cumulative dosage of doxorubicin HCl exceeding the currently recommended limit of 550 mg/m^2 or will exceed the 550 mg/m^2 dosage limit during the course of the current study. A subject will also be excluded if they received a lower cumulative dosage of doxorubicin HCl (i.e., 400 mg/m^2) and also had prior radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents such as cyclophosphamide. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative doxorubicin HCl dosage;
- Women who are pregnant or are breast-feeding;
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- Corrected QT interval (QTc) ≥480 msec (average of three measurements to be made at screening);
- The subject has diabetes mellitus with poor glycemic control;
- The subject has a history of human immunodeficiency virus (HIV) or other immunodeficiency disease;
- The subject has positive Hepatitis B surface antigen;
- The subject has a history of a severe infusion-related reaction following treatment with pegylated liposomal doxorubicin as described in the protocol;
- The subject has an acute infection or severe or uncontrolled infections requiring systemic antibiotic therapy;
- Any serious medical or psychiatric disorder that would interfere with subject safety or informed consent;
- Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol;
- Known leptomeningeal disease or evidence of prior or current metastatic brain disease. Routine screening with central nervous system (CNS) imaging studies (CT or MRI) is required only if clinically indicated;
- Receiving concurrent chemotherapy, immunotherapy, radiotherapy, or investigational therapy;
- Oral corticosteroids within 14 days of study entry;
- History of ventricular arrhythmias requiring drug or device therapy;
- Any investigational drug within 30 days or five half-lives (whichever is longer) preceding the first dose of SB-485232;
- The subject has active signs of a bowel obstruction.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Philadelphia, Pennsylvania, 19104
GSK Investigational Site
Stanford, California, 94305-5317
About this study
Official title: A Phase I, Dose Escalation Study to Assess the Safety & Biological Activity of Interleukin 18 (SB-485232) Administered by IV Infusion in Combination With Pegylated Liposomal Doxorubicin (Doxil) in Advanced Stage Epithelial Ovarian Cancer
The purpose of this study is to identify a dose of SB-485232 which is safe, tolerable and biologically active when used in combination with pegylated liposomal doxorubicin (Doxil) in patients with epithelial ovarian cancer. This study will use a standard treatment regimen of pegylated liposomal doxorubicin (Doxil) in combination with rising doses of SB-485232. The dose selected from this study will be used in a future studies to evaluate the efficacy of this combination.
- Conditions
- Neoplasms, Ovarian
- Being tested
- SB-485232 (interleukin 18), pegylated liposomal doxorubicin
- Keywords
- Doxil,, pegylated liposomal doxorubicin,, ovarian cancer, IL-18,, combination study,, immunotherapy,, cytokine,
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SB-485232 (interleukin 18), pegylated liposomal doxorubicinDrug
Also called SB-485232 (interleukin 18), pegylated liposomal doxorubicin
SB-485232 (interleukin 18), pegylated liposomal doxorubicin
| Study group | Role | What they receive |
|---|---|---|
| SB-485232 plus pegylated liposomal doxorubicin | Experimental | Subjects will receive one dose of pegylated liposomal doxorubicin on Day 1 plus two doses of SB-485232 on Day 3 and Day 9 in each cycle. Receives: Drug: SB-485232 (interleukin 18), pegylated liposomal doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of SB-485232/Doxil combination therapy
Measured: 16 weeks
Secondary outcomes (5)
Biological activity of SB-485232/Doxil combination therapy
Measured: 16 weeks
Pharmacokinetic parameters for SB-485232 and Doxil: AUC(0-t), Cmax, and Cmin
Measured: 16 weeks
Pharmacodynamic biomarker responses
Measured: 16 weeks
Immunogenicity (anti-SB-485232 and anti-PEG antibodies)
Measured: 16 weeks
Anti-tumor activity (Radiographic tumor assessments and serum CA-125 levels)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2008 (estimated)
- Study start18 Jun 2008
- Primary completion18 Feb 2011
- Study completion18 Feb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasms, OvarianStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00659178
- Sponsor's protocol ID
- ILI108621
- Status last verified
- Jul 2017
- First submitted
- 10 Apr 2008
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Dose Escalation Study to Assess the Safety & Biological Activity of Interleukin 18 (SB-485232) Administered by IV Infusion in Combination With Pegylated Liposomal Doxorubicin (Doxil) in Advanced Stage Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT00659178
- Acronym / sponsor ID
- ILI108621
- Conditions
- Neoplasms, Ovarian
- Keywords
- Doxil,, pegylated liposomal doxorubicin,, ovarian cancer, IL-18,, combination study,, immunotherapy,, cytokine,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Jun 2008 (actual)
- Primary completion
- 18 Feb 2011 (actual)
- Study completion
- 18 Feb 2011 (actual)
- First posted
- 16 Apr 2008 (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 identify a dose of SB-485232 which is safe, tolerable and biologically active when used in combination with pegylated liposomal doxorubicin (Doxil) in patients with epithelial ovarian cancer. This study will use a standard treatment regimen of pegylated liposomal doxorubicin (Doxil) in combination with rising doses of SB-485232. The dose selected from this study will be used in a future studies to evaluate the efficacy of this combination.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SB-485232 plus pegylated liposomal doxorubicin | Experimental | Drug: SB-485232 (interleukin 18), pegylated liposomal doxorubicinSubjects will receive one dose of pegylated liposomal doxorubicin on Day 1 plus two doses of SB-485232 on Day 3 and Day 9 in each cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female, age ≥18 years of age;
- Histologically confirmed diagnosis of epithelial ovarian, fallopian tube, or primary peritoneal carcinoma;
- Candidate to receive pegylated liposomal doxorubicin for treatment of advanced stage ovarian cancer as per standard of care and in the opinion of the treating principal investigator;
- Measurable lesion(s) according to RECIST v1.0;
- ECOG performance status of 0, 1 or 2;
Key exclusion criteria (20 listed)
- Significant cardiac, pulmonary, metabolic, renal, hepatic, gastrointestinal or autoimmune conditions that in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as participant in this trial;
- Any severe concurrent disease or condition, including significant active autoimmune diseases such as rheumatoid arthritis, which in the judgment of the principal investigator, would make the subject inappropriate for study participation;
- History of myocardial infarction, unstable angina, or acute coronary syndrome within the past six months;
- The subject has a history of hypersensitivity reactions to a conventional formulation of doxorubicin HCl or the components of pegylated liposomal doxorubicin;
- The subject has a history of receiving a total cumulative dosage of doxorubicin HCl exceeding the currently recommended limit of 550 mg/m^2 or will exceed the 550 mg/m^2 dosage limit during the course of the current study. A subject will also be excluded if they received a lower cumulative dosage of doxorubicin HCl (i.e., 400 mg/m^2) and also had prior radiotherapy to the mediastinal area or concomitant therapy with other potentially cardiotoxic agents such as cyclophosphamide. Prior use of other anthracyclines or anthracenediones should be included in calculations of total cumulative doxorubicin HCl dosage;
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 |
|---|---|---|
| SB-485232 (interleukin 18), pegylated liposomal doxorubicinAlso: SB-485232 (interleukin 18), pegylated liposomal doxorubicinSB-485232 (interleukin 18), pegylated liposomal doxorubicin | Drug | SB-485232 plus pegylated liposomal doxorubicin |
Primary outcome
Safety and tolerability of SB-485232/Doxil combination therapy
Time frame: 16 weeks
5 secondary outcomes
Biological activity of SB-485232/Doxil combination therapy
Time frame: 16 weeks
Pharmacokinetic parameters for SB-485232 and Doxil: AUC(0-t), Cmax, and Cmin
Time frame: 16 weeks
Pharmacodynamic biomarker responses
Time frame: 16 weeks
Immunogenicity (anti-SB-485232 and anti-PEG antibodies)
Time frame: 16 weeks
Anti-tumor activity (Radiographic tumor assessments and serum CA-125 levels)
Time frame: 16 weeks
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 21 Jul 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study ILI108621 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 SB-485232 (interleukin 18), pegylated liposomal doxorubicin in people with Neoplasms, Ovarian, run by GlaxoSmithKline 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 14 inclusion and 20 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 21 Jul 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?
Safety and tolerability of SB-485232/Doxil combination therapy (time frame: 16 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 21 Jul 2017.