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

Not Applicable

• Conditions: -D695 Secondary thrombocytopenia; Secondary thrombocytopenia; D695

• Registration Number: PER-078-05
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-01-10
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Patients> 18 years of age, without previous chemotherapy treatment, with advanced solid tumor with histological or cytological confirmation.
2. Patients who will receive first-line chemotherapy with carboplatin ABC 5-6 EV in 30 minutes plus paclitaxel 175-225 mg / m2 EV in three hours on day 1 every 21 days.
3. Functional State ECOG-Zubrod 0 or 1.
4. The patient has no history of platelet alterations and has no history of hemorrhagic diseases.
5. Patients have an adequate: Hematological function, liver function, renal function.

Exclusion Criteria

1. Any clinically relevant abnormality, in addition to cancer or any other medical condition or circumstance that makes the subject unfit to participate in the study and / or which could hinder the interpretation of the patient´s data.
2. Patient with a known history of accelerated progressive disease, surgery within 2 weeks prior, radiotherapy within the previous 4 weeks or any previous chemotherapy.
3. Patients with known prior heart disease.
4. Patients with abnormal 12-lead ECG.
5. Patients with known coagulation diseases that are associated with hypercoagulability.
6. The patient consumed aspirin, compounds containing aspirin, salicylates, quinine or nonsteroidal anti-inflammatory drugs (NSAIDs) for> 3 consecutive days within 2 weeks of the start of the study and could require them at any time during the study.
7. Treatment with an investigational drug within 30 days or 5 half-lives before the study.
8. The patient consumed liquid antacids, chewable antacids or calcium supplements within 48 hours of the first dose of the study medication.
9. The patient consumed rosuvastatin or pravastatin within one week of the first dose of study medication.
10. Any history of drug-induced thrombocytopenia.
11. Use of systemic anticoagulants within 4 weeks prior to entry into the study.
12. Consumption of any phytotherapeutic supplement or dietary supplements, within 1 week of the beginning of the study.
13. Female patients who are breastfeeding or have a beta-hCG positive test in the screening study.
14. Patients with a history of CNS metastasis or signs or clinical symptoms of brain and / or leptomeningeal metastases with CT confirmation or brain MRI examination.

Study & Design

• Study Type: Interventional
• Study Design: Not specified