ThrombocytopaeniaPhase 1NCT00358540
Dose Finding Study Of Oral Eltrombopag In Patients With Sarcoma Receiving Adriamycin And Ifosfamide
A Phase 1 study testing eltrombopag in people with Thrombocytopaenia, run by GlaxoSmithKline at 7 sites in United States.
Trial summary
The study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thrombocytopaenia
- What is being tested?
- eltrombopag
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 7 sitesUnited States
- Study dates
- 1 Jun 2006to 22 Oct 2010
- 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
- Adult subjects, 18 years or older
- Adequate liver and kidney function
- Prior history of ≥grade 2 thrombocytopenia (platelet nadir ≤ 75,000/microliters)
- Ability to ingest and retain oral medication
- Practice acceptable birth control
- Ability to understand and follow study requirements
- Life expectancy of at least 3 months
Who cannot join
- History of platelet disorders, dysfunction, or a bleeding disorder
- Anti-coagulant used within 2 weeks prior to study start
- Females who are lactating or expecting
- History of thromboembolic events or drug induced thrombocytopenia
- History of central nervous system, brain and/or leptomeningeal metastases
- Prior surgery within 2 weeks or radiotherapy within 4 weeks of study start
- Pre-existing cardiac disease
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Greenville, South Carolina, 29605
GSK Investigational Site
Houston, Texas, 77030-4009
GSK Investigational Site
Miami, Florida, 33136
GSK Investigational Site
Philadelphia, Pennsylvania, 19106
GSK Investigational Site
Santa Monica, California, 90403
GSK Investigational Site
Tampa, Florida, 33612
About this study
Official title: An Open-label, Dose Ranging Study to Assess the Safety, Efficacy, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (Eltrombopag) Administered to Subjects Receiving Adriamycin and Ifosfamide (AI) Regimen
The study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.
- Conditions
- Thrombocytopaenia
- Being tested
- eltrombopag
- Keywords
- sarcoma, eltrombopag, thrombopoiesis, thrombocytopenia
- Medical subject headings
- Thrombocytopenia, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eltrombopagDrug
Dosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide.
| Study group | Role | What they receive |
|---|---|---|
| Group B | Experimental | Group B is a dose escalation phase designed to determine the optimal biological dose of eltrombopag in subjects with sarcoma who received chemotherapy treatment with Adriamycin and Ifosfamide Receives: Drug: eltrombopag |
| Group A | Experimental | Group A will be used for further exploration of the optimal biological dose (as initially established by completion of Group B), by using 2 different dosing schedules of eltrombopag. Receives: Drug: eltrombopag |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters
Measured: Approximately 42 weeks
Secondary outcomes (3)
OBD will be determined by evaluating platelet count time course data, platelet nadirs, degree and duration of thrombocytopenia, and platelet count recovery from nadir
Measured: Approximately 18 weeks
Eltrombopag AUC(0-t)
Measured: Approximately 4 weeks
Doxorubicin and doxorubicinol PK
Measured: Approximately 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2006 (estimated)
- Study start1 Jun 2006
- Primary completion22 Oct 2010
- Study completion22 Oct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ThrombocytopaeniaStudies 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 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
- NCT00358540
- Sponsor's protocol ID
- TRC105499
- Status last verified
- Nov 2017
- First submitted
- 28 Jul 2006
- Last updated
- 13 Nov 2017
- Results posted
- No
Publications
Hayes S, Mudd PN Jr, Ouellet D, Johnson BM, Williams D, Gibiansky E. Population PK/PD modeling of eltrombopag in subjects with advanced solid tumors with chemotherapy-induced thrombocytopenia. Cancer Chemother Pharmacol. 2013 Jun;71(6):1507-20. doi: 10.1007/s00280-013-2150-9. Epub 2013 Apr 6.
PubMed 23564375Chawla SP, Staddon A, Hendifar A, Messam CA, Patwardhan R, Kamel YM. Results of a phase I dose escalation study of eltrombopag in patients with advanced soft tissue sarcoma receiving doxorubicin and ifosfamide. BMC Cancer. 2013 Mar 16;13:121. doi: 10.1186/1471-2407-13-121.
PubMed 23497336
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Dose Ranging Study to Assess the Safety, Efficacy, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (Eltrombopag) Administered to Subjects Receiving Adriamycin and Ifosfamide (AI) Regimen
- ClinicalTrials.gov ID
- NCT00358540
- Acronym / sponsor ID
- TRC105499
- Conditions
- Thrombocytopaenia
- Keywords
- sarcoma, eltrombopag, thrombopoiesis, thrombocytopenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2006 (actual)
- Primary completion
- 22 Oct 2010 (actual)
- Study completion
- 22 Oct 2010 (actual)
- First posted
- 1 Aug 2006 (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 study will evaluate the safety and tolerability, optimal biologic dose, and pharmacokinetics of eltrombopag for patients with advanced sarcoma who have a low platelet count and are receiving ADRIAMYCIN and ifosfamide (AI) chemotherapy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B | Experimental | Drug: eltrombopagGroup B is a dose escalation phase designed to determine the optimal biological dose of eltrombopag in subjects with sarcoma who received chemotherapy treatment with Adriamycin and Ifosfamide |
| Group A | Experimental | Drug: eltrombopagGroup A will be used for further exploration of the optimal biological dose (as initially established by completion of Group B), by using 2 different dosing schedules of eltrombopag. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult subjects, 18 years or older
- Adequate liver and kidney function
- Prior history of ≥grade 2 thrombocytopenia (platelet nadir ≤ 75,000/microliters)
- Ability to ingest and retain oral medication
- Practice acceptable birth control
Key exclusion criteria (7 listed)
- History of platelet disorders, dysfunction, or a bleeding disorder
- Anti-coagulant used within 2 weeks prior to study start
- Females who are lactating or expecting
- History of thromboembolic events or drug induced thrombocytopenia
- History of central nervous system, brain and/or leptomeningeal metastases
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 |
|---|---|---|
| eltrombopagDosing of sarcoma subjects with eltrombopag after treatment with Adriamycin and Ifosfamide. | Drug | Group A, Group B |
Primary outcome
Safety and tolerability endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters
Time frame: Approximately 42 weeks
3 secondary outcomes
OBD will be determined by evaluating platelet count time course data, platelet nadirs, degree and duration of thrombocytopenia, and platelet count recovery from nadir
Time frame: Approximately 18 weeks
Eltrombopag AUC(0-t)
Time frame: Approximately 4 weeks
Doxorubicin and doxorubicinol PK
Time frame: Approximately 4 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 13 Nov 2017.
- Background: PubMed 23564375Hayes S, Mudd PN Jr, Ouellet D, Johnson BM, Williams D, Gibiansky E. Population PK/PD modeling of eltrombopag in subjects with advanced solid tumors with chemotherapy-induced thrombocytopenia. Cancer Chemother Pharmacol. 2013 Jun;71(6):1507-20. doi: 10.1007/s00280-013-2150-9. Epub 2013 Apr 6.
- Derived from this study: PubMed 23497336Chawla SP, Staddon A, Hendifar A, Messam CA, Patwardhan R, Kamel YM. Results of a phase I dose escalation study of eltrombopag in patients with advanced soft tissue sarcoma receiving doxorubicin and ifosfamide. BMC Cancer. 2013 Mar 16;13:121. doi: 10.1186/1471-2407-13-121.
- Results for study 105499 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
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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
7 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 eltrombopag in people with Thrombocytopaenia, run by GlaxoSmithKline at 7 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 7 inclusion and 7 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 endpoints will consist of the evaluation of adverse events (AE), and changes from baseline in vital signs and clinical laboratory parameters (time frame: Approximately 42 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00358540, which also lists 2 linked publications.
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 13 Nov 2017.