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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00274443 |
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Date of registration:
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10/01/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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An Open Label Study in Patients With Advanced NSCLC With ABI-007(Abraxane) in Combination With Carboplatin
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Scientific title:
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An Open -Label, Phase II Trial of Increasing Doses of ABI-007 and Carboplatin in Patients With Advanced Non Small Cell Lung Cancer (NSCLC) |
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Date of first enrolment:
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March 1, 2005 |
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Target sample size:
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250 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00274443 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Russian Federation
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Ukraine
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Histologically or cytologically confirmed NSCLC Stage IIIB with pleural effusion or
evidence of inoperable local recurrence or metastasis (Stage IV).
- Male or non-pregnant and non-lactating female, and = 18 years of age. ( )If a female
patient is of child-bearing potential, as evidenced by regular menstrual periods, she
must have a negative serum pregnancy test (ß-hCG) documented within 72 hours of the
first administration of study drug. ( )If sexually active, the patient must agree to
utilize contraception considered adequate and appropriate by the investigator.
- No other current active malignancy.
- Measurable disease
- Patients must have received no prior therapy for the treatment of metastatic disease.
- Patient has the following blood counts at baseline:
( ) ANC = 1.5 x 109/L; ( ) platelets = 100 x 109/L; ( ) Hgb = 9 g/dL.
- Patient has the following blood chemistry levels at baseline:
( ) AST (SGOT), ALT (SGPT) = 1.5x upper limit of normal range (ULN); ( ) total bilirubin
NORMAL; ( ) creatinine = 1.5 mg/dL.
- Expected survival of > 12 weeks.
- ECOG performance status 0 or 1.
- Patient or his/her legally authorized representative or guardian has been informed
about the nature of the study, and has agreed to participate in the study, and signed
the Informed Consent form prior to participation in any study-related activities.
Exclusion Criteria:
- Evidence of active brain metastases, including leptomeningeal involvement. Prior
evidence of brain metastasis permitted only if treated and stable off therapy for at
least 1 month.
- The only evidence of metastasis is bone metastases or other nonmeasurable disease.
- Patient has pre-existing peripheral neuropathy of grade 2, 3, or 4.
- Patient received radiotherapy in last 4 weeks, except if to a non-target lesion only.
Prior radiation to a target lesion is permitted only if there has been clear
progression of the lesion since radiation was completed.
- Patient has a clinically significant concurrent illness.
- Patient is, in the investigator's opinion, unlikely to be able to complete the study
through the End of Study visit.
- Patient has received treatment with any other cytotoxic chemotherapeutic agent or
investigational drug within the previous 4 weeks;
- Patient has a history of allergy or hypersensitivity to the study drug.
- Patient has serious medical risk factors involving any of the major organ systems such
that the investigator considers it unsafe for the patient to receive an experimental
research drug.
- Patient is enrolled in any other clinical protocol or investigational trial.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-Small Cell Lung Cancer (NSCLC)
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Intervention(s)
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Drug: ABI-007 (Abraxane) and Carboplatin
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Primary Outcome(s)
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Efficacy Outcomes: percentage of patients who achieve an objective confirmed complete or partial overall antitumor response
[Time Frame: Treatment duration]
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Safety Outcomes: incidence of treatment emergent adverse events.
[Time Frame: Treatment duration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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