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A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Phase I Study of GRN163L in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer


GRN163L is a telomerase template antagonist with in vitro and in vivo activity in a variety
of tumor model systems. Telomerase is an enzyme that is active primarily in tumor cells and
is crucial for the indefinite growth of tumor cells. Inhibition of telomerase may result in
antineoplastic effects.


Inclusion Criteria:



- Histologically or cytologically confirmed diagnosis of NSCLC

- Stage IIIb with pleural effusion, Stage IV, or recurrent disease

- Measurable or evaluable disease by RECIST criteria

- ECOG performance status 0-1

- Adequate hepatic/renal function and platelet count

- If previously treated with an anthracycline, anthracenedione, or trastuzumab, must
have left ventricular ejection fraction > 50%

Exclusion Criteria:

- More than 2 prior chemotherapy regimens for metastatic disease (prior adjuvant
chemotherapy is allowed)

- Tumor progression during treatment with paclitaxel (refractory to paclitaxel)

- Taxane-based regimen within 12 weeks

- Any systemic therapy for cancer within 4 weeks

- Anti-platelet therapy within 2 weeks, other than low dose aspirin prophylaxis therapy

- Therapeutic anticoagulation therapy except for low dose warfarin (eg, 1 mg by mouth
per day)

- Radiation therapy within 3 weeks

- Major surgery within 4 weeks (central line placement is allowed)

- Prolongation of PT or aPTT > the ULN or fibrinogen < the LLN

- History of or active central nervous system metastatic disease

- Any other active malignancy

- Active or chronically recurrent bleeding (eg, active peptic ulcer disease)

- Clinically significant infection

- Active autoimmune disease requiring immunosuppressive therapy

- Clinically significant cardiovascular disease or condition

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and MTD

Outcome Time Frame:

First 3 weeks

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

GRN163L CP14A005

NCT ID:

NCT00510445

Start Date:

July 2007

Completion Date:

April 2011

Related Keywords:

  • Lung Cancer
  • Non Small Cell Lung Cancer
  • Advanced Non Small Cell Lung Cancer
  • Metastatic Non Small Cell Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
University of Maryland Greenebaum Cancer CenterBaltimore, Maryland  21201
The University of Texas Southwestern Medical CenterDallas, Texas  75390
University of Wisconsin, Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792