Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues.

Detailed Description
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This is a clinical trial examining the vascular disrupting agent NPI-2358 combined with docetaxel in patients with advanced non-small cell lung cancer (NSCLC). The formation of new blood vessels (angiogenesis) is an important component of tumor growth, vascular disrupting agents are intended to target the differences between these tumor blood vessels and the blood vessels in normal tissues. There are indications of advantages in combining vascular disrupting agents with standard agents in the treatment of advanced non-small cell lung cancer (NSCLC).

Official Title
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Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer

Conditions
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Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: NPI-2358 + docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and females ≥ 18 years of age ECOG performance status ≤ 1 Pathologically or histologically confirmed advanced non-small cell lung cancer (unresectable Stage IIIb or IV) that has progressed after treatment with at least one chemotherapy regimen; measurable disease is not required for enrollment into this trial All Adverse Events of any prior chemotherapy, surgery, or radiotherapy, must have resolved to Grade ≤ 2 Signed informed consent Exclusion Criteria: Administration of certain chemotherapy, biological, immunotherapy, radiation therapy, surgery or investigational agent within specified time frames Significant cardiac history Prior treatment with tumor vascular disruptive agents Seizure disorder Brain metastases Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy Known infection with human immunodeficiency virus (HIV), or active hepatitis A, B, or C Patients with a prior hypersensitivity reaction to product components Pregnant or breast-feeding women. Concurrent, active second malignancy for which the patient is receiving therapy, excluding basal cell carcinoma of the skin or carcinoma in situ of the cervix Unwilling or unable to comply with procedures required in this protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: docetaxel<br>docetaxel (75 mg/m2) | Drug: docetaxel<br>* docetaxel (75 mg/m2)<br>* Other names: docetaxel (Taxotere);|
| Experimental: NPI-2358 + docetaxel<br>NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2) | Drug: NPI-2358 + docetaxel<br>* NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)<br>* Other names: NPI-2358; docetaxel (Taxotere);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358 |  | Continuous | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare response rate, duration of response, 6-month survival, progression free survival and safety. |  | Continuous | 
| Pharmacokinetics |  | Continuous | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non Small Cell Lung