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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Thrombocytopenia, Thrombocytopaenia

Thank you

Trial Information

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


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

Inclusion 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

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)

Outcome Time Frame:

throughout entire study

Principal Investigator

GSK Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

GlaxoSmithKline

Authority:

United States: Food and Drug Administration

Study ID:

497115/003

NCT ID:

NCT00102726

Start Date:

February 2005

Completion Date:

February 2007

Related Keywords:

  • Thrombocytopenia
  • Thrombocytopaenia
  • chemotherapy
  • thrombopoietin
  • platelets
  • chemotherapy induced
  • Thrombocytopenia

Name

Location

GSK Investigational SiteLittle Rock, Arkansas  72205
GSK Investigational SiteBakersfield, California  93309
GSK Investigational SiteGainesville, Florida  32610
GSK Investigational SiteNew Orleans, Louisiana  70112
GSK Investigational SiteDuluth, Minnesota  55805
GSK Investigational SiteRaleigh, North Carolina  27609
GSK Investigational SiteAkron, Ohio  44304
GSK Investigational SiteSavannah, Georgia  31405
GSK Investigational SiteSalem, Virginia  24153
GSK Investigational SiteNew York, New York  10021
GSK Investigational SiteHattiesburg, Mississippi  39401