Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
Trial record 23 of 198 for:    Oral Cancer | ( Map: Mexico )

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00102726
Recruitment Status : Completed
First Posted : February 2, 2005
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Brief 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 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.

Condition or disease Intervention/treatment Phase
Thrombocytopaenia Drug: SB497115 Other: Placebo Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : February 2005
Actual Primary Completion Date : February 2007
Actual Study Completion Date : February 2007

Arm Intervention/treatment
Active Comparator: Arm 1
SB-497115-GR 50mg. administered orally daily on days 2 through 11 for each 21-day cycle.
Drug: SB497115
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.

Active Comparator: Arm 2
SB-497115-GR 75 mg administered orally dailey on days 2-11 of each 21-day cycle.
Drug: SB497115
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.

Active Comparator: Arm 3
SB-497115 100mg administered orally daily on days 2 through 11 of each 21-day cycle.
Drug: SB497115
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.

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




Primary Outcome Measures :
  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) [ Time Frame: throughout entire study ]

Secondary Outcome Measures :
  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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: throughout study ]
  6. The relationship between PK of SB-497115 andrelevant safety and efficacy endpoints will be explored [ Time Frame: 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 [ Time Frame: throughout study ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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).

  • 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.

Exclusion criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00102726


Locations
Hide Hide 95 study locations
Layout table for location information
United States, Arizona
GSK Investigational Site
Tucson, Arizona, United States, 85715
United States, Arkansas
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
United States, California
GSK Investigational Site
Greenbrae, California, United States, 94904-2007
GSK Investigational Site
Long Beach, California, United States, 90813
GSK Investigational Site
Los Angeles, California, United States, 90033
GSK Investigational Site
Los Angeles, California, United States, 90095
United States, Colorado
GSK Investigational Site
Colorado Springs, Colorado, United States, 80907
United States, Delaware
GSK Investigational Site
Newark, Delaware, United States, 19718
United States, Florida
GSK Investigational Site
Boca Raton, Florida, United States, 33428
GSK Investigational Site
Hollywood, Florida, United States, 33021
GSK Investigational Site
Tamarac, Florida, United States, 33321
United States, Georgia
GSK Investigational Site
Savannah, Georgia, United States, 31405
United States, Louisiana
GSK Investigational Site
Metairie, Louisiana, United States, 70006
United States, Maryland
GSK Investigational Site
Baltimore, Maryland, United States, 21237-3998
United States, Minnesota
GSK Investigational Site
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
GSK Investigational Site
Hattiesburg, Mississippi, United States, 39401
GSK Investigational Site
Tupelo, Mississippi, United States, 38801
United States, Nevada
GSK Investigational Site
Las Vegas, Nevada, United States, 89102
United States, New York
GSK Investigational Site
Babylon, New York, United States, 11702
GSK Investigational Site
New York, New York, United States, 10032
United States, North Carolina
GSK Investigational Site
Durham, North Carolina, United States, 27707
United States, Ohio
GSK Investigational Site
Akron, Ohio, United States, 44304
GSK Investigational Site
Mayfield Heights, Ohio, United States, 44124
GSK Investigational Site
Toledo, Ohio, United States, 43614-5809
United States, Texas
GSK Investigational Site
Bryan, Texas, United States, 77802
United States, Utah
GSK Investigational Site
Ogden, Utah, United States, 84403
United States, Virginia
GSK Investigational Site
Salem, Virginia, United States, 24153
Argentina
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, C1405BCK
GSK Investigational Site
La Plata, Buenos Aires, Argentina, 1900
GSK Investigational Site
Rosario, Santa Fe, Argentina, 2000
GSK Investigational Site
Rosario, Santa Fe, Argentina, S2000KZE
GSK Investigational Site
Buenos Aires, Argentina, 1425
GSK Investigational Site
Buenos Aires, Argentina, C1416DRW
Austria
GSK Investigational Site
Vienna, Austria, A-1090
GSK Investigational Site
Vienna, Austria, A-1100
GSK Investigational Site
Vienna, Austria, A-1140
Bulgaria
GSK Investigational Site
Plovdiv, Bulgaria, 4000
GSK Investigational Site
Sofia, Bulgaria, 1527
GSK Investigational Site
Sofia, Bulgaria, 1756
GSK Investigational Site
Sofia, Bulgaria, 1784
Czech Republic
GSK Investigational Site
Brno, Czech Republic, 656 53
GSK Investigational Site
Praha 8, Czech Republic, 180 81
Germany
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
GSK Investigational Site
Regensburg, Bayern, Germany, 93049
GSK Investigational Site
Marburg, Hessen, Germany, 35033
GSK Investigational Site
Hemer, Nordrhein-Westfalen, Germany, 58675
GSK Investigational Site
Trier, Rheinland-Pfalz, Germany, 54290
GSK Investigational Site
Grosshansdorf, Schleswig-Holstein, Germany, 22927
GSK Investigational Site
Bad Berka, Thueringen, Germany, 99437
GSK Investigational Site
Berlin, Germany, 13353
GSK Investigational Site
Hamburg, Germany, 21075
Hungary
GSK Investigational Site
Budapest, Hungary, 1529
GSK Investigational Site
Székesfehérvár, Hungary, 8000
India
GSK Investigational Site
Bangalore, India, 560 034
GSK Investigational Site
Hyderabad, Andhra Pradesh, India, 500482
GSK Investigational Site
Kolkatta, India, 700 054
GSK Investigational Site
Vellore, India, 632 004
Italy
GSK Investigational Site
Benevento, Campania, Italy, 82100
GSK Investigational Site
Roma, Lazio, Italy, 00168
GSK Investigational Site
Milano, Lombardia, Italy, 20141
GSK Investigational Site
Campobasso, Molise, Italy, 86100
Korea, Republic of
GSK Investigational Site
Seoul, Korea, Republic of, 135-710
GSK Investigational Site
Seoul, Korea, Republic of, 138-736
Mexico
GSK Investigational Site
Merida, Yucatán, Mexico, 97500
Peru
GSK Investigational Site
Lima, Peru, Lima 34
Poland
GSK Investigational Site
Olsztyn, Poland, 10-228
GSK Investigational Site
Poznan, Poland, 60-569
GSK Investigational Site
Poznan, Poland, 61-866
GSK Investigational Site
Szczecin, Poland, 70-891
GSK Investigational Site
Wroclaw, Poland, 53-413
Romania
GSK Investigational Site
Bucuresti, Romania, 022328
Russian Federation
GSK Investigational Site
Moscow Region, Russian Federation, 143 423
GSK Investigational Site
Moscow, Russian Federation, 115 478
GSK Investigational Site
Moscow, Russian Federation, 117997
GSK Investigational Site
Moscow, Russian Federation, 129301
GSK Investigational Site
St. Petersburg, Russian Federation, 197758
GSK Investigational Site
St. Petersburg, Russian Federation, 198255
Spain
GSK Investigational Site
Badalona, Spain, 08916
GSK Investigational Site
Barcelona, Spain, 08036
GSK Investigational Site
Cordoba, Spain, 14004
GSK Investigational Site
Madrid, Spain, 28006
GSK Investigational Site
Santa Cruz de Tenerife, Spain, 38320
GSK Investigational Site
Santander, Spain, 38008
GSK Investigational Site
Sevilla, Spain, 41014
Taiwan
GSK Investigational Site
Taipei, Taiwan, 100
GSK Investigational Site
Tau-Yuan County, Taiwan, 333
Ukraine
GSK Investigational Site
Dnepropetrovsk, Ukraine, 49102
GSK Investigational Site
Donetsk, Ukraine, 83092
GSK Investigational Site
Kyiv, Ukraine, 03115
GSK Investigational Site
Lvov, Ukraine, 79031
United Kingdom
GSK Investigational Site
Truro, Cornwall, United Kingdom, TR1 3LJ
GSK Investigational Site
Chelmsford, Essex, United Kingdom, CM1 7ET
GSK Investigational Site
Colchester, United Kingdom, CO3 3NB
GSK Investigational Site
Dundee, United Kingdom, DD1 9SY
GSK Investigational Site
Leicester, United Kingdom, LE1 5WW
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Layout table for investigator information
Study Director: GSK Clinical Trials GlaxoSmithKline

Publications:
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00102726    
Other Study ID Numbers: 497115/003
First Posted: February 2, 2005    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Keywords provided by GlaxoSmithKline:
chemotherapy
thrombopoietin
platelets
chemotherapy induced
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases