CTRI/2012/06/002736
Other
Phase 1
A Safety, Tolerability, Pharmacokinetic, and Efficacy Study of Docetaxel InjectionConcentrate for Nano-Dispersion (DICN) in Subjects With Unresectable LocallyAdvanced or Metastatic Non Small Cell Lung Cancer (NSCLC)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Sun Pharma Advanced Research Company Ltd
- Enrollment
- 30
- Status
- Other
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\.Histologically or cytologically diagnosed unresectable locally advanced19 or metastatic NSCLC with taxane\-based therapy a rational treatment option;
- •2\.Must have been treated with at least one prior chemotherapy regimen or targeted EGFR inhibitor for locally advanced or metastatic NSCLC;
- •3\.Male or female subjects with age 18 to 70 years, inclusive;
- •4\.Performance status \<\= 2 on the ECOG performance scale;
- •5\.Estimated life expectancy of at least 12\-weeks;
- •6\.Measurable or evaluable disease as per RECIST 1\.1 criteria;
- •7\.Adequate organ and immune system function as indicated by the following laboratory values, obtained \<\= 2 weeks prior to dosing:
- •Hematology:ANC \>\= 1\.5 Ã? 109/L, Hemoglobin \>\= 9\.0 g/dL, Platelets \>\= 100 Ã? 109/L
- •Renal:Serum creatinine \<\= 2\.0 mg/dL
- •Hepatic:Total bilirubin \<\= upper limit of normal (ULN, Aspartate aminotransferase (AST) \<\= 1\.5 Ã? ULN, Alanine aminotransferase (ALT) \<\= 1\.5 Ã? ULN, Alkaline phosphatase \<\= 5 Ã? ULN
Exclusion Criteria
- •1\.Prior adjuvant chemotherapy or biological therapy for relapsed NSCLC if completed less than 1 year prior to first relapse of locally advanced19 or metastatic disease (prior surgery or radiotherapy allowed);
- •2\.Prior docetaxel therapy for NSCLC;
- •3\.Clinically significant third\-space fluid collection (e.g., ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to enrollment;
- •4\.Any other malignancy within 5 years with the exception of adequately treated basal or squamous cell skin cancer or adequately treated in situ carcinoma;
- •5\.Known hypersensitivity to the study drugs or their excipients or analogs;
- •6\.Treatment with any investigational agents within 30 days of enrollment;
- •7\.Active and uncontrolled infection;
- •8\.Psychiatric disorders or alcohol/chemical abuse that would interfere with consent or follow\-up;
- •9\.Presence of clinically symptomatic central nervous system (CNS) metastases or carcinomatous meningitis;
- •10\.Pre\-existing peripheral neuropathy (Grade 2 or higher â?? as per CTCAE);
Outcomes
Primary Outcomes
Not specified
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