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ThrombocytopaeniaPhase 2NCT00102726

SB-497115 (Oral Thrombopoietin Receptor Agonist) Versus Placebo In Adult Cancer Patients Receiving Chemotherapy

A Phase 2 study testing SB497115 in people with Thrombocytopaenia, run by GlaxoSmithKline at 95 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 versus placebo as treatment for patients with advanced solid tumors scheduled to receive chemotherapy with carboplatin and paclitaxel… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Thrombocytopaenia
What is being tested?
SB497115
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
183 participants
Where
95 sitesin 19 countries
Study dates
Feb 2005to Feb 2007
Phase
Phase 2
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

  • Subjects ≥18 years old, who are chemotherapy naïve, with histologically or cytologically confirmed advanced solid tumor (leukemia and lymphoma are excluded) who are scheduled to received carboplatin/paclitaxel as shown below. For the purpose of this study, advanced tumors are defined as tumors that are being treated with palliative intent (i.e., not being treated with curative intent).
  • Subjects scheduled to receive first-line chemotherapy as carboplatin AUC 5-6 IV over 30 minutes plus paclitaxel 175-225 mg/m2 IV over 3 hours on day 1 every 21 days, with routine pre-medications, i.e., 20 mg dexamethasone [or equivalent] orally 6 and 12 hours pre-paclitaxel, 50 mg IV diphenhydramine [or equivalent] and 300 mg IV cimetidine [or equivalent] 30-60 minutes pre-paclitaxel.
  • ECOG-Zubrod performance status is 0, or 1.
  • Subject has no history of platelet disorders or dysfunction and no history of a bleeding disorder.
  • Subjects have adequate:
  • hematologic function (ANC ≥ 1,500/mm3, hemoglobin ≥ 9 g/dL, and platelet count ≥100,000/mm3 and < upper limit of normal range (eg, 400,000 to 450,000/mm3), hepatic function (bilirubin ≤ 2 mg/dL and alanine aminotransferase ≤ three times the upper limit of normal), renal function (creatinine ≤ 2.0 mg/dL).
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  • Subject has no physical limitation to ingest and retain oral medication.
  • Subject has life expectancy of at least 6 months.
  • Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of nonchildbearing potential (hysterectomy, bilateral oophorectomy, bilateral tubal ligation or post-menopausal > 1 year), or of childbearing potential and use one of the following acceptable methods of contraception from two weeks prior to administration of study medication, throughout the study, and 28 days after completion or premature discontinuation from the study:
  • Complete abstinence from intercourse; Intrauterine device (IUD); Two forms of barrier contraception (diaphragm plus spermicide, and for males condom plus spermicide); Male partner is sterile prior to entry into the study and is the only partner of the female; Systemic contraceptives (combined or progesterone only).
  • Subject is able to understand and comply with protocol requirements and instructions and intend to complete the study as planned.
  • Subject has signed and dated written informed consent.
  • Chemotherapy naive patients with advanced solid tumors (without brain metastasis or rapid progression within 2 weeks) who are scheduled to receive standard first-line therapy with carboplatin and paclitaxel every 21 days.
  • Adequate hematologic, hepatic and renal function.

Who cannot join

  • Any clinically relevant abnormality, other than cancer, identified on the screening examination, or any other medical condition or circumstance, which in the opinion of the Investigator, makes the subject unsuitable for participation in the study and/or would make the patient's data difficult to interpret.
  • Subjects with a known history of rapidly progressive disease (marked increase in tumor size [>50%], ascites, or serious symptoms related to underlying cancer in the preceding 4-week period), surgery within the previous 2 weeks, radiotherapy within the previous 4 weeks, or any prior chemotherapy.
  • Subjects with known pre-existing cardiac disease, including congestive heart failure, arrhythmias requiring treatment, or myocardial infarction within the preceding 3 months.
  • Subjects with abnormal resting 12-lead ECG at screening that would indicate preexisting cardiac disease, as noted in exclusion criterion 3.
  • Subjects with known clotting disorder associated with hypercoaguability.
  • Subject has consumed aspirin, aspirin-containing compounds, salicylates, quinine or non-steroidal anti-inflammatories (NSAIDs) for > 3 consecutive days within 2 weeks of the study start and would require them at any time during the study.
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  • Treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) preceding the first dose of study medication.
  • Subject has consumed liquid antacids (e.g. Maalox, Mylanta, Amphogel, milk of magnesia), chewable antacids (e.g. TUMS) or calcium supplements within 48 hours of the first dose of study medication, and/or will require these medications during the study.
  • Subject has consumed rosuvastatin or pravastatin within 1 week of the first dose of study medication and/or will require these medications at any time during the study.
  • Any history of drug-induced thrombocytopenia (e.g., quinine).
  • Systemic anti-coagulant use within 4 weeks prior to study entry.
  • Consumption of any herbal or dietary supplements, excluding vitamin or mineral supplements (See Exclusion 8 for calcium supplements), within 1 week of the study start.
  • Female subjects who are lactating or have a positive beta-hCG at screening.
  • Subjects with a history of CNS metastases or clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan.
  • History of platelet or bleeding disorders.
  • Patients using aspirin, aspirin-containing compounds, salicylates, antacids, rosuvastatin, pravastatin, non-steroidal anti-inflammatory drugs for greater than 3 days during and within 3 weeks prior to the study.
  • Females who are pregnant or breastfeeding.

Trial locations and contacts

95 sites in 19 countries.

95 sites in 19 countries

United States27 sites

  • GSK Investigational Site

    Akron, Ohio, 44304

  • GSK Investigational Site

    Babylon, New York, 11702

  • GSK Investigational Site

    Baltimore, Maryland, 21237-3998

  • GSK Investigational Site

    Boca Raton, Florida, 33428

  • GSK Investigational Site

    Bryan, Texas, 77802

  • GSK Investigational Site

    Colorado Springs, Colorado, 80907

  • GSK Investigational Site

    Durham, North Carolina, 27707

  • GSK Investigational Site

    Greenbrae, California, 94904-2007

  • GSK Investigational Site

    Hattiesburg, Mississippi, 39401

  • GSK Investigational Site

    Hollywood, Florida, 33021

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Las Vegas, Nevada, 89102

  • GSK Investigational Site

    Long Beach, California, 90813

  • GSK Investigational Site

    Los Angeles, California, 90033

  • GSK Investigational Site

    Los Angeles, California, 90095

  • GSK Investigational Site

    Mayfield Heights, Ohio, 44124

  • GSK Investigational Site

    Metairie, Louisiana, 70006

  • GSK Investigational Site

    Minneapolis, Minnesota, 55455

  • GSK Investigational Site

    New York, New York, 10032

  • GSK Investigational Site

    Newark, Delaware, 19718

  • GSK Investigational Site

    Ogden, Utah, 84403

  • GSK Investigational Site

    Salem, Virginia, 24153

  • GSK Investigational Site

    Savannah, Georgia, 31405

  • GSK Investigational Site

    Tamarac, Florida, 33321

  • GSK Investigational Site

    Toledo, Ohio, 43614-5809

  • GSK Investigational Site

    Tucson, Arizona, 85715

  • GSK Investigational Site

    Tupelo, Mississippi, 38801

Other trials in United States

Germany9 sites

  • GSK Investigational Site

    Bad Berka, Thuringia, 99437

  • GSK Investigational Site

    Berlin, State of Berlin, 13353

  • GSK Investigational Site

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • GSK Investigational Site

    Großhansdorf, Schleswig-Holstein, 22927

  • GSK Investigational Site

    Hamburg, Free and Hanseatic City of Hamburg, 21075

  • GSK Investigational Site

    Hemer, North Rhine-Westphalia, 58675

  • GSK Investigational Site

    Marburg, Hesse, 35033

  • GSK Investigational Site

    Regensburg, Bavaria, 93049

  • GSK Investigational Site

    Trier, Rhineland-Palatinate, 54290

Other trials in Germany

Spain7 sites

  • GSK Investigational Site

    Badalona, 08916

  • GSK Investigational Site

    Barcelona, 08036

  • GSK Investigational Site

    Córdoba, 14004

  • GSK Investigational Site

    Madrid, 28006

  • GSK Investigational Site

    Santa Cruz de Tenerife, 38320

  • GSK Investigational Site

    Santander, 38008

  • GSK Investigational Site

    Seville, 41014

Other trials in Spain

Argentina6 sites

  • GSK Investigational Site

    Buenos Aires, Buenos Aires, 1425

  • GSK Investigational Site

    Buenos Aires, C1416DRW

  • GSK Investigational Site

    Capital Federal, Buenos Aires, C1405BCK

  • GSK Investigational Site

    La Plata, Buenos Aires, 1900

  • GSK Investigational Site

    Rosario, Santa Fe Province, 2000

  • GSK Investigational Site

    Rosario, Santa Fe Province, S2000KZE

Other trials in Argentina

Russia6 sites

  • GSK Investigational Site

    Moscow, 115 478

  • GSK Investigational Site

    Moscow, 117997

  • GSK Investigational Site

    Moscow, 129301

  • GSK Investigational Site

    Moscow Region, 143 423

  • GSK Investigational Site

    Saint Petersburg, 197758

  • GSK Investigational Site

    Saint Petersburg, 198255

Other trials in Russia

Poland5 sites

  • GSK Investigational Site

    Olsztyn, 10-228

  • GSK Investigational Site

    Poznan, 60-569

  • GSK Investigational Site

    Poznan, 61-866

  • GSK Investigational Site

    Szczecin, 70-891

  • GSK Investigational Site

    Wroclaw, 53-413

Other trials in Poland

United Kingdom5 sites

  • GSK Investigational Site

    Chelmsford, Essex, CM1 7ET

  • GSK Investigational Site

    Colchester, CO3 3NB

  • GSK Investigational Site

    Dundee, DD1 9SY

  • GSK Investigational Site

    Leicester, LE1 5WW

  • GSK Investigational Site

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Bulgaria4 sites

  • GSK Investigational Site

    Plovdiv, 4000

  • GSK Investigational Site

    Sofia, 1527

  • GSK Investigational Site

    Sofia, 1756

  • GSK Investigational Site

    Sofia, 1784

Other trials in Bulgaria

India4 sites

  • GSK Investigational Site

    Bangalore, 560 034

  • GSK Investigational Site

    Hyderabad, Andhra Pradesh, 500482

  • GSK Investigational Site

    Kolkata, 700 054

  • GSK Investigational Site

    Vellore, 632 004

Other trials in India

Italy4 sites

  • GSK Investigational Site

    Benevento, Campania, 82100

  • GSK Investigational Site

    Campobasso, Molise, 86100

  • GSK Investigational Site

    Milan, Lombardy, 20141

  • GSK Investigational Site

    Rome, Lazio, 00168

Other trials in Italy

Ukraine4 sites

  • GSK Investigational Site

    Dnipro, 49102

  • GSK Investigational Site

    Donetsk, 83092

  • GSK Investigational Site

    Kyiv, 03115

  • GSK Investigational Site

    Lviv, 79031

Other trials in Ukraine

Austria3 sites

  • GSK Investigational Site

    Vienna, A-1090

  • GSK Investigational Site

    Vienna, A-1100

  • GSK Investigational Site

    Vienna, A-1140

Other trials in Austria

Czechia2 sites

  • GSK Investigational Site

    Brno, 656 53

  • GSK Investigational Site

    Prague, 180 81

Other trials in Czechia

Hungary2 sites

  • GSK Investigational Site

    Budapest, 1529

  • GSK Investigational Site

    Székesfehérvár, 8000

Other trials in Hungary

South Korea2 sites

  • GSK Investigational Site

    Seoul, 135-710

  • GSK Investigational Site

    Seoul, 138-736

Other trials in South Korea

Taiwan2 sites

  • GSK Investigational Site

    Taipei, 100

  • GSK Investigational Site

    Tau-Yuan County, 333

Other trials in Taiwan

Mexico1 site

  • GSK Investigational Site

    Mérida, Yucatán, 97500

Other trials in Mexico

Peru1 site

  • GSK Investigational Site

    Lima, Lima Province, Lima 34

Other trials in Peru

Romania1 site

  • GSK Investigational Site

    Bucharest, 022328

Other trials in Romania

About this study

Official title: A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Assess the Efficacy, Safety, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist(SB497115-GR) Administered at 50, 75, and 100 mg to Cancer Patients Receiving Multiple Cycles of Chemotherapy

SB497115 is an oral agent which activates the thrombopoietin receptor and increases platelet counts in healthy volunteers. This study is examining several different doses of SB497115 versus placebo as treatment for patients with advanced solid tumors scheduled to receive chemotherapy with carboplatin and paclitaxel every 21 days. Patients will receive SB497115 on days 2-11 of each 21 day cycle for at least 2 cycles of chemotherapy and for a maximum of 8 cycles of chemotherapy.

Read the detailed description

A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel Group, Dose Ranging Study to Assess the Efficacy, Safety, and Pharmacokinetics of an Oral Thrombopoietin Receptor Agonist (SB-497115-GR) Administered at 50, 75, and 100 mg to Cancer Patients Receiving Multiple Cycles of Chemotherapy

Being tested
SB497115, Placebo
Keywords
chemotherapy, thrombopoietin, platelets, chemotherapy induced
Medical subject headings
Thrombocytopenia, Jacobs syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB497115Drug

    SB497115/Placebo will be administered for at least 2 cycles. Additional cycles are permited if: 1) chemotherapy is continued, 2) the subject appears to be benefitting from the study drug, and 3) the subject has not encountered greater than moderate toxicity with the study drug. The maximum number of cycles would be 8.

  • PlaceboOther

    Placebo administered orally daily on days 2 through 11 of each 21-day cycle.

Study groups in NCT00102726
Study groupRoleWhat they receive
Arm 1Active comparatorSB-497115-GR 50mg. administered orally daily on days 2 through 11 for each 21-day cycle.
Receives: Drug: SB497115
Arm 2Active comparatorSB-497115-GR 75 mg administered orally dailey on days 2-11 of each 21-day cycle.
Receives: Drug: SB497115
Arm 3Active comparatorSB-497115 100mg administered orally daily on days 2 through 11 of each 21-day cycle.
Receives: Drug: SB497115
Placebo ArmPlacebo comparatorPlacebo administered orally daily on days 2 through 11 of each 21-day cycle.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in baseline platelet count from the first day of the second cycle of chemotherapy to the lowest count observed (nadir) during the cycle(21 days)

    Measured: throughout entire study

Secondary outcomes (9)

  1. Safety and tolerability, pharmacodynamics, changes in platelet count during cycle 1(21 days) and beyond cycle 2(21 days), population PK, and deliver intended doses of chemotherapy without thrombocytopenia related AEs

    Measured: Throughout entire study

  2. Safety and tolerability as indicated by physical exam, 12-lead ECGs, ophthalmologic examinations, clinical laboratory tests, clinical monitoring/observation, and AE reporting

    Measured: throughout study

  3. Pharmacodynamic parameters including platelet count, grade of thrombocytopenia,serum thrombopoietin, and platelet aggregation/activation during the first and second cycles of carboplatin/paclitaxel

    Measured: During first and second cycles of carboplatin/paclitaxel

  4. Change in platelet count from day 1 (baseline) to nadir during the first cycle and beyond the second cycle of carboplatin/paclitaxel

    Measured: throughout study

  5. Population PK of SB-497115, including clearance (CL/F), absorption rate constant(ka), and volume of distribution (V/F) with assessment of demographic covariates influencing SB-497115 PK

    Measured: throughout study

  6. The relationship between PK of SB-497115 andrelevant safety and efficacy endpoints will be explored

    Measured: throughout study

  7. Dose intensity (percent of intended dose) of carboplatin/paclitaxel

  8. Carboplatin/paclitaxel-associated thrombocytopenia-related AEs, as defined by NCI

  9. Common Terminology Criteria for Adverse Events, CTCAE v3.0, to include the number of platelet transfusions, bleeding events (hematoma), hemorrhage/bleeding,petechiae/purpura), clinical laboratory tests, and clinical observations

    Measured: throughout study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionFeb 2007
  4. Study completionFeb 2007

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00102726
Sponsor's protocol ID
497115/003
Status last verified
Mar 2017
First submitted
1 Feb 2005
Last updated
23 Mar 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 23564375

  • Kellum A, Jagiello-Gruszfeld A, Bondarenko IN, Patwardhan R, Messam C, Mostafa Kamel Y. A randomized, double-blind, placebo-controlled, dose ranging study to assess the efficacy and safety of eltrombopag in patients receiving carboplatin/paclitaxel for advanced solid tumors. Curr Med Res Opin. 2010 Oct;26(10):2339-46. doi: 10.1185/03007995.2010.510051.

    PubMed 20735290

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SB497115 in people with Thrombocytopaenia, run by GlaxoSmithKline at 95 sites in 19 countries.

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 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 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States, Germany, Spain, Argentina, Russia and 14 more countries. 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. Some participants in this study may receive a placebo. 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?

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?

Change in baseline platelet count from the first day of the second cycle of chemotherapy to the lowest count observed (nadir) during the cycle(21 days) (time frame: throughout entire study). 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 NCT00102726, 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 23 Mar 2017.

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