CancerPhase 1/2NCT00630110
Phase 1/2 Study of Vascular Disrupting Agent NPI-2358 + Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
A Phase 1/2 study testing docetaxel and NPI-2358 + docetaxel in people with Cancer, run by Nereus Pharmaceuticals, Inc. at 36 sites in 6 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- docetaxel and NPI-2358 + docetaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 36 sitesin 6 countries
- Study dates
- Feb 2008to Jun 2011
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
36 sites in 6 countries.
36 sites in 6 countries
India9 sites
Kidwai Memorial Institute of Oncology
Bangalore, 560029
Apollo Speciality Hospital
Chennai, 600035
Apollo Hospital
Hyderabad, 500033
SEAROC Cancer Centre S.K. Soni Hospital
Jaipur, 302013
Chittaranjan National Cancer Institute
Kolkata, West Bengal, 700026
Subodh Mitra Cancer Hospital & Research Centre
Kolkata
Tata Memorial Hospital
Mumbai, 530002
Ruby Hall Clinic
Pune, 411011
Andhra Medical College
Visakhapatnam
United States8 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Karmanos Cancer Institute
Detroit, Michigan, 48201
San Diego Pacific Oncology & Hematology Associates
Encinitas, California, 92024
University Texas Health Science Center at San Antonio (CTRC)
San Antonio, Texas, 78229
University San Diego Moores Cancer Center
San Diego, California, 92093
Kaiser Permanente
San Diego, California, 92108
Premiere Oncology
Santa Monica, California, 90404
Mayo Clinic
Scottsdale, Arizona, 85259
Brazil8 sites
Fundacap Pip XII Hospital do Cancer de Barretos
Barretos
Hospital Erasto Gaertner Liga do Combate as Cancer
Curitiba
Associacao Hospital de Caridade Ijui
Ijuí
Hospital Sao Lucas
Porte Alegre
Hospital de clinicas de Porto Alegre
Porto Alegre, 90035
Clinionco-Clinica de Oncologia de Porto Alegre
Porto Alegre
Hosp.das Clinicas da Univ.de Sao Paulo
São Paulo
Instituto do Cancer Aenaldo Vieira de Carvahlo
São Paulo
Argentina6 sites
Policlinica Privada Instituto de Medicina Nuclear
Bahía Blanca
Hospital Britanico
Capital Federal
Instituto Oncologico De Cordoba
Córdoba, 5000 CRD
Clinica Universitaria Privada Reina Fabiola
Córdoba, 5000CRD
Caici Centro de Asistencia e Investigacion Clinica Integral
Rosario
Hospital del Centrenario
Rosario
Australia3 sites
Bendigo Health Care Group
Bendigo, Victoria
Sir Charles Gairdner Hospital
Nedlands, Western Australia, 6009
Mater Adult Hospital
South Brisbane, Queensland, 4101
Chile2 sites
Instituto Nacional del Cancer Oncology
Santiago
Hospital Carlos Van Buren
Valparaíso
About this study
Official title: Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
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.
Read the 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).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
docetaxelDrug
Also called docetaxel (Taxotere)
docetaxel (75 mg/m2)
NPI-2358 + docetaxelDrug
Also called NPI-2358; docetaxel (Taxotere)
NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2)
| Study group | Role | What they receive |
|---|---|---|
| docetaxel | Active comparator | docetaxel (75 mg/m2) Receives: Drug: docetaxel |
| NPI-2358 + docetaxel | Experimental | NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2) Receives: Drug: NPI-2358 + docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
Measured: Continuous
Secondary outcomes (2)
Compare response rate, duration of response, 6-month survival, progression free survival and safety.
Measured: Continuous
Pharmacokinetics
Measured: Continuous
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2008 (estimated)
- Study startFeb 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nereus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Matthew A Spear, MD, Study director, Chief Medical Officer, Nereus Pharmaceuticals, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00630110
- Sponsor's protocol ID
- NPI-2358-101
- Status last verified
- Aug 2011
- First submitted
- 26 Feb 2008
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Vascular Disrupting Agent NPI-2358 in Combination With Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00630110
- Acronym / sponsor ID
- NPI-2358-101
- Conditions
- Cancer
- Keywords
- Non Small Cell Lung
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Nereus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 6 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| docetaxel | Active comparator | Drug: docetaxeldocetaxel (75 mg/m2) |
| NPI-2358 + docetaxel | Experimental | Drug: NPI-2358 + docetaxelNPI-2358 (30 mg/m2) + docetaxel (75 mg/m2) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| docetaxelAlso: docetaxel (Taxotere)docetaxel (75 mg/m2) | Drug | docetaxel |
| NPI-2358 + docetaxelAlso: NPI-2358; docetaxel (Taxotere)NPI-2358 (30 mg/m2) + docetaxel (75 mg/m2) | Drug | NPI-2358 + docetaxel |
Primary outcome
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358
Time frame: Continuous
2 secondary outcomes
Compare response rate, duration of response, 6-month survival, progression free survival and safety.
Time frame: Continuous
Pharmacokinetics
Time frame: Continuous
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew A Spear, MD study director
Chief Medical Officer, Nereus Pharmaceuticals, Inc
36 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing docetaxel and NPI-2358 + docetaxel in people with Cancer, run by Nereus Pharmaceuticals, Inc. at 36 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in India, United States, Brazil, Argentina, Australia and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare overall survival of patients treated with docetaxel to patients treated with docetaxel + NPI-2358 (time frame: Continuous). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.