Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
This study has been completed.
Sponsor:
Nereus Pharmaceuticals, Inc.
Information provided by:
Nereus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT00630110
First received: February 26, 2008
Last updated: August 15, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cancer |
Drug: docetaxel Drug: NPI-2358 + docetaxel |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer |
Resource links provided by NLM:
Further study details as provided by Nereus Pharmaceuticals, Inc.:
Primary Outcome Measures:
- Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358 [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Compare response rate, duration of response, 6-month survival, progression free survival and safety. [ Time Frame: Continuous ] [ Designated as safety issue: Yes ]
- Pharmacokinetics [ Time Frame: Continuous ] [ Designated as safety issue: No ]
| Enrollment: | 172 |
| Study Start Date: | February 2008 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: docetaxel
docetaxel (75 mg/m2)
|
Drug: docetaxel
docetaxel (75 mg/m2)
Other Name: docetaxel (Taxotere)
|
|
Experimental: NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
|
Drug: NPI-2358 + docetaxel
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
Other Name: NPI-2358; docetaxel (Taxotere)
|
Detailed Description:
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).
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00630110
Show 36 Study Locations
Show 36 Study LocationsSponsors and Collaborators
Nereus Pharmaceuticals, Inc.
Investigators
| Study Director: | Matthew A Spear, MD | Chief Medical Officer, Nereus Pharmaceuticals, Inc |
More Information
No publications provided
| Responsible Party: | Kristine C. Federico, RN BSN - Director Clinical Development, Nereus Pharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00630110 History of Changes |
| Other Study ID Numbers: | NPI-2358-101 |
| Study First Received: | February 26, 2008 |
| Last Updated: | August 15, 2011 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration United States: Food and Drug Administration India: Drugs Controller General of India Chile: Instituto de Salud Publica de Chile |
Keywords provided by Nereus Pharmaceuticals, Inc.:
|
Non Small Cell Lung |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Lung Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Docetaxel Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013