Hemotrial Un proyecto de SEHH

Ensayo clínico

A Double-blind, Randomised, Multicentre, 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

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2017-03-15 03:55:19
2004-000368-28
SB-497115/003
A Double-blind, Randomised, Multicentre, 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
SB-497115/003

PROMOTORES DEL ENSAYO
Nombre del promotor Organización Persona de contacto País
GlaxoSmithKline Group of Companies United Kingdom

Fármacos

  INFORMACIÓN DE FÁRMACOS USADOS:
  FÁRMACO 1:
Test
SB497115
SB497115 Tablet
Oral use

Detalles del Fármaco (Principio Activo):
SB497115 TPO

Concentración del fármaco:
mg milligram(s) equal

25

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  FÁRMACO 2:
Test
SB497115
SB497115 Tablet
Oral use

Detalles del Fármaco (Principio Activo):
SB497115 TPO

Concentración del fármaco:
mg milligram(s) equal

50

Contenido del fármaco

Si
No

No
Information no disponible en EudraCT

No
No

Information no disponible en EudraCT
Information no disponible en EudraCT

Information no disponible en EudraCT
No

No
No

No
  INFORMACIÓN DE PLACEBOS USADOS:
  PLACEBO 1:

Si
Tablet

Oral use

Información General

Trombopenia

Chemotherapy-Induced Thrombocytopenia (CIT)

To evaluate the efficacy of oral SB-497115-GR at doses of 50, 75, and 100 mg compared with placebo in cycle 2 of carboplatin/paclitaxel chemotherapy, administered to subjects with an advanced solid tumour.

•Safety and tolerability of oral SB-497115-GR when administered to subjects receiving multiple cycles of carboplatin/paclitaxel chemotherapy. •Pharmacodynamic effect of SB-497115-GR on platelet count and function when administered to subjects receiving multiple cycles of carboplatin/paclitaxel chemotherapy. •Efficacy of SB-497115-GR at doses of 50, 75, and 100 mg in the first cycle and beyond the second cycle of carboplatin/paclitaxel chemotherapy. •Population PK profile of oral SB-497115. •To assess dose intensity of carboplatin/paclitaxel chemotherapy (percent of intended dose delivered) administered to the subjects who are also treated with oral SB-497115-GR. •Incidence and severity of thrombocytopenia-related adverse events (AEs) in subjects receiving multiple cycles of carboplatin/paclitaxel for the treatment of an advanced solid tumor who are also treated with oral SB-497115-GR

Information no disponible en EudraCT


1. Subjects ?18 years old, who are chemotherapy naïve, with histologically confirmed advanced solid tumor (leukemia and lymphoma are excluded) who are scheduled to received carboplatin/paclitaxel as shown below. 2. 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. 3. ECOG-Zubrod performance status is 0, or 1. 4. Subject has no history of platelet disorders or dysfunction and no history of a bleeding disorder. 5. Subjects have adequate: • hematologic function (ANC ? 1,500/mm3, hemoglobin ? 9 mg/dL, and platelets ?100,000/mm3 and < 600,000/mm3) • hepatic function (bilirubin ? 2 mg/dL and alanine aminotransferase ? three times the upper limit of normal), • renal function (creatinine ? 2.0 mg/dL). 6. Subject has no physical limitation to ingest and retain oral medication. 7. Subject has life expectancy of at least 6 months. 8. Subject is practicing an acceptable method of contraception (documented in chart). Female subjects (or female partners of male subjects) must either be of non-childbearing potential (hysterectomy, bilateral oopherectomy, 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). 9. Subject is able to understand and comply with protocol requirements and instructions and intend to complete the study as planned. 10. Subject has signed and dated written informed consent

1. 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. 2. Subjects with known pre-existing cardiac disease, including congestive heart failure, arrhythmias requiring treatment, or myocardial infarction within the preceding 3 months. 3. Subjects with abnormal resting 12-lead ECG at screening that would indicate pre-existing cardiac disease, as noted in exclusion criterion 2. 4. Subjects with known clotting disorder associated with hypercoaguability. 5. Subject has consumed aspirin, aspirin-containing compounds, salicylates, anti-coagulants, 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. 6. Subject has consumed liquid antacids (e.g. Maalox™, Mylanta™, Amphogel™, milk of magnesia) or chewable antacids (e.g. TUMS™) within 48 hours of the first dose of study medication, and would require them at any time during the study. 7. 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. 8. Any history of drug-induced thrombocytopenia (e.g., quinine). 9. Anti-coagulant use within 4 weeks prior to study entry. 10. Consumption of any herbal supplements, excluding vitamin or mineral supplements, within 1 week of the study start. 11. Female subjects who are lactating or have a positive beta-hCG at screening. 12. 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

The primary endpoint is the change in platelet count from day 1 in cycle 2 (baseline) to cycle 2 nadir

Fase II
  DISEÑO DEL ENSAYO:

Si
Si

Information no disponible en EudraCT
Information no disponible en EudraCT

Si
Information no disponible en EudraCT

Information no disponible en EudraCT
Information no disponible en EudraCT
  COMPARADOR DEL ENSAYO CONTROLADO:

Information no disponible en EudraCT
Si

Information no disponible en EudraCT
Information no disponible en EudraCT

Si

Centros participantes:

Si
Information no disponible en EudraCT
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO:

0
8
  TIEMPO ESTIMADO DURACIÓN DEL ENSAYO EN ESPAÑA:


  POBLACIÓN DE PACIENTES EN EL ESTUDIO:
  Población de pacientes: 1

Rango de edad:

0
1

1

Sexo:

1
1

Número planeado de pacientes a incluir:

20

Para estudios internacionales:

120
164

Investigadores

  INVESTIGADORES QUE PARTICIPAN EN EL ESTUDIO

Estado actual


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