Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00510445
• Other study ID #: GRN163L CP14A005
• Status: Completed
• Phase: Phase 1
• First received: July 31, 2007
• Last updated: December 22, 2015
• Start date: July 2007
• Est. completion date: April 2011

Study information

• Verified date: December 2015
• Source: Geron Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine the safety and the maximum tolerated dose (MTD) of GRN163L when administered in combination with a standard paclitaxel/carboplatin regimen to patients with advanced or metastatic non-small cell lung cancer.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Imetelstat Sodium (GRN163L)
The starting dose of GRN163L for this study will be 3.2 mg/kg. Subsequent dose levels will be 4.8, 6, 7.5, 9, 11, and 13.5 mg/kg. The maximum dose to be administered will not exceed 13.5 mg/kg. Paclitaxel and carboplatin will be administered on Day 2 of each 21-day cycle.

Locations

Country	Name	City	State
United States	University of Maryland Greenebaum Cancer Center	Baltimore	Maryland
United States	The University of Texas Southwestern Medical Center	Dallas	Texas
United States	UT MD Anderson Cancer Center	Houston	Texas
United States	University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Geron Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and MTD		First 3 weeks	Yes
Secondary	PK and efficacy		Baseline to end of treatment	No

External Links

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