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A Safety, Tolerability and Preliminary Efficacy Evaluation of CC-90011 Given in Combination With Cisplatin and Etoposide in Subjects With First Line, Extensive Stage Small Cell Lung Cancer - CC-90011-SCLC-001

Actualizada: 28 febrero, 2021   |   ClinicalTrials.gov

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Detalles del estudio

  • Phase 1/Phase 2

    Fase

  • Géneros

  • 18+

    Rango de edad

  • 10

    Ubicación (es)

  • Recruiting

Opciones de tratamiento

Brazos del estudio
INTERVENCIÓN ASIGNADA
Experimental: CC-90011 in combination with Carboplatin and Etoposide
Drug: Carboplatin Drug: Etoposide
Experimental: CC-90011 in combination with Cisplatin and Etoposide
Drug: CC-90011 Drug: Cisplatin
Experimental: Nivolumab combination
Drug: Nivolumab

Criterios clave de elegibilidad

Inclusion Criteria: 1. Male and female subject is 18 years of age or older at the time of signing the informed consent form (ICF). 2. Subject with histological or cytological confirmation of extensive stage SCLC according to 2015 WHO classification (Travis, 2015). 3. Subject must be able to provide fresh or archival tumor tissues 4. Subject is found suitable for at least 4 cycles of platinum-based standard chemotherapy. 5. Subject has at least 1 site of measurable disease per RECIST 1.1. 6. Subject must have the following laboratory values: - Absolute neutrophil count (ANC) ≥ 1.5 x 109/L - Hemoglobin (Hgb) ≥ 10 g/dL (≥ 100 g/L or > 6.2 mmol/L) - Platelet count (Plt) ≥ 150 x 109/L - Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase/serum glutamate pyruvate transaminase (ALT/SGPT) ≤ 3.0 x upper limit of normal (ULN) or ≤ 5.0 x ULN if liver metastases are present - Serum total bilirubin ≤ 1.5 x ULN - Serum albumin ≥ 3.0 g/dL - Serum creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 60 mL/min (see Appendix G to see creatinine clearance formula). For the purposes of this protocol, the glomerular filtration rate (GFR) is considered to be equivalent to the creatinine clearance. - Prothrombin time (or international normalized ratio [INR]) and activated partial thromboplastin time (APTT) ≤ 1.5 ULN Exclusion Criteria: 1. Subject has received anticancer therapy (either approved or investigational, including radiation with curative intent) for SCLC prior to study entry. 2. Subject has undergone major surgery ≤ 4 weeks prior to Cycle 1 Day 1 or has not recovered from surgery. 3. Subject has persistent diarrhea due to a malabsorptive syndrome (such as celiac sprue or inflammatory bowel disease) ≥ NCI CTCAE Grade 2, despite medical management), or any other significant gastrointestinal (GI) disorder that could affect the absorption of CC- 90011. 4. Subject with symptomatic or uncontrolled ulcers (gastric or duodenal), particularly those with a history of and/or risk of perforation and GI tract hemorrhages. 5. Subject with any hemorrhage/bleeding event > CTCAE Grade 2 or hemoptysis > 1 teaspoon within 4 weeks prior to the first dose. 6. Subject with symptomatic and untreated or unstable central nervous system (CNS) metastases. 7. Subject has impaired cardiac function or clinically significant cardiac diseases, including any of the following: - Left ventricular ejection fraction (LVEF) < 45% as determined by multigated acquisition (MUGA) scan or echocardiogram (ECHO). - Complete left bundle branch or bifascicular block. - Congenital long QT syndrome. - Persistent or clinically meaningful ventricular arrhythmias or atrial fibrillation. - QTcF ≥ 480 msec on Screening ECG (mean of triplicate recordings). 8. Subject has other clinically significant heart disease such as congestive heart failure requiring treatment or uncontrolled hypertension (blood pressure ≥ 160/95 mm Hg). 9. Subject is a pregnant or nursing female. 10. Subject has known human immunodeficiency virus (HIV) infection. 11. Subject has known chronic active hepatitis B or C virus (HBV, HCV) infection. 12. Subject with ongoing treatment with chronic, therapeutic dosing of anticoagulants (eg, warfarin, low molecular weight heparin, Factor Xa inhibitors, thrombin antagonist). 13. Subject has a history of concurrent second cancers requiring active, ongoing systemic treatment. 14. Subject has Grade 2 peripheral sensory neuropathy. 15. Subject with poor bone marrow reserve as assessed by Investigator. 16. Subject has any condition including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 17. Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study. 18. Subject has any condition that confounds the ability to interpret data from the study. For the subjects treated with nivolumab: 19. Subject has received prior therapies targeting PD-1 or PD-L1 20. Subject has a history of persistent skin rash ≥ NCI CTCAE Grade 2. 21. Subject with an autoimmune disease, or any other condition, requiring systemic treatment with either corticosteroids within 14 days (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 30 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease. • Subjects with type 1 diabetes mellitus, hypothyroidism only requiring hormone replacement, disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll. 22. Subject has received treatment with botanical preparations (eg, herbal supplements or traditional Chinese medicines) to treat the disease under study within 2 weeks prior to randomization. Refer to Section 8.2 for prohibited therapies. 23. Subject has history of allergy or hypersensitivity to study drug components. 24. Subject has received a live/attenuated vaccine within 30 days of first treatment.

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