FORTIS-C: A Phase 3, Randomized, Placebo-controlled Study of Oral Talactoferrin in Combination With Carboplatin and Paclitaxel as First-line Therapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer
| City: |
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Chattanooga |
| State: |
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Tennessee |
| Zip Code: |
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37404 |
| Conditions: |
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Non Small Cell Lung Cancer |
| Purpose: |
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The purpose of the study is to determine whether the combination of talactoferrin,
carboplatin and paclitaxel improves progression free survival and overall survival in
patients with non-small cell lung cancer compared to the combination of paclitaxel and
carboplatin alone
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria:
- Confirmed locally advanced or metastatic non-small cell lung cancer that is
unresectable
- At least 1 unirradiated target lesion measurable by RECIST
- Adequate hematologic, renal and hepatic function
- ECOG 0,1
- Able to understand and sign an Informed Consent
Exclusion Criteria:
- Presence of brain metastases, unless the patient received brain irradiation,
including adequate stereotactic radiosurgery, at least 4 weeks prior to
randomization, and is stable, asymptomatic, and off steroids for at least 3 weeks
prior to randomization
- Received prior systemic anti-cancer therapy for NSCLC
- History of allergic reactions to compounds of similar chemical or biologic
composition to talactoferrin or the chemotherapy drugs
- Any gastrointestinal tract disease or other medical condition resulting in the
inability to take oral medications
- History of other malignancies except: (i) adequately treated basal or squamous cell
carcinoma of the skin; (ii) curatively treated, a) in situ carcinoma of the uterine
cervix, b) prostate cancer, or c) superficial bladder cancer; or (iii) other
curatively treated solid tumor with no evidence of disease for ≥5 years
- Uncontrolled ischemic heart disease, or uncontrolled symptomatic congestive heart
failure
- Serious active infection
- Psychiatric illness/social situations that would limit study compliance
- Other uncontrolled serious chronic disease or conditions that in the investigator's
opinion could render compliance or follow-up in the protocol problematic
- Concurrent radiotherapy or radiotherapy within 4 weeks prior to randomization or
previous radiotherapy at the indicator sites (the sites that are to be followed for
determination of a response)
- Concurrent systemic corticosteroid therapy within 4 weeks prior to randomization,
except prophylactic use of steroids prior to paclitaxel administration
- Known HIV positive or on active anti-retroviral therapy
- Known Hepatitis B surface antigen positive or hepatitis C positive
- Receipt of any investigational medication within 4 weeks prior to randomization
- Pregnant or lactating patients, or fertile female patients with a positive pregnancy
test, or fertile female patients unwilling to use adequate contraception during
treatment and for 30 days after completion of treatment
- Sexually active male patients unwilling to practice contraception while participating
on the study and up to 30 days after completion of treatment
- Legal incapacity or limited legal capacity, unless authorization is granted by a
legal guardian
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| NCT ID: |
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NCT00706862 |
| Primary Contact: |
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Yenyun Wang, MD
Phone: 713-552-1091
Email: ywang@agennix.com
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| Backup Contact: |
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Email: rmalik@agennix.com
Rajesh Malik, MD
Phone: 713-552-1091
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| Location Contact: |
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Chattanooga, Tennessee 37404
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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