Recruiting
Phase 3

Talactoferrin with Chemotherapy

Sponsor:

Agennix

Code:

NCT00706862

Conditions

Non Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Talactoferrin

Placebo

Study Details

Brief summary:

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

Conditions

Non Small Cell Lung Cancer

Study ID

NCT00706862

Start date

Feb, 2009

Status verified date

Mar, 2012

Completion date

Mar, 2016

Anticipated

Primary completion date

Jun, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Talactoferrin, Carboplatin, Paclitaxel

placebo comparator: 2

Placebo, Carboplatin, Paclitaxel

Interventions

Talactoferrin

Oral, 1.5 grams twice per day

Placebo

Oral, twice per day

Primary outcome measure

  • Overall Survival [ Time Frame: After the occurence of the required number of events ]
  • Progression free survival [ Time Frame: At the time of final analysis ]

Central Contacts and Locations

Central contacts

Yenyun Wang, MD

713-552-1091ywang@agennix.com

Rajesh Malik, MD

713-552-1091rmalik@agennix.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

Karen Reckamp

Montefiore Medical Center

Recruiting

Bronx, New York, United States, 10467

Principal Investigator:

Missak Haigentz

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Jeffrey Crawford

Chattanooga Oncology and Hematology Associates

Recruiting

Chattanooga, Tennessee, United States, 37404

Principal Investigator:

Davey Daniel

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

Principal Investigator:

David Spigel

More Information

Sponsor

Agennix

Last update posted

Mar 15, 2012

Last verified

Mar, 2012

Keywords

  • Non small cell lung cancer
  • Talactoferrin
  • Dendritic cell recruiter and activator
  • DCRA
  • Immunomodulatory agent
  • Lactoferrin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Agennix on 2012-03-15.