NCT00510445

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at P25-P50 for phase_1 lung-cancer

Timeline
Completed

Started Jul 2007

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 2, 2007

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

December 24, 2015

Status Verified

December 1, 2015

Enrollment Period

3.8 years

First QC Date

July 31, 2007

Last Update Submit

December 22, 2015

Conditions

Lung Cancer

Keywords

Non Small Cell Lung CancerAdvanced Non Small Cell Lung CancerMetastatic Non Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • Safety and MTD

    First 3 weeks

Secondary Outcomes (1)

  • PK and efficacy

    Baseline to end of treatment

Study Arms (1)

Single Arm Trial

EXPERIMENTAL

Patients will be enrolled in the order of confirmation of eligibility. Dose cohorts will be filled sequentially with a minimum of 3 patients. Once assigned to a dose cohort, each patient will continue to be treated at the same dose level throughout the course of the study.

Drug: Imetelstat Sodium (GRN163L)

Interventions

Imetelstat Sodium (GRN163L)DRUG

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.

Single Arm Trial

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, 21201, United States

Location

The University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

imetelstat

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2007

First Posted

August 2, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

December 24, 2015

Record last verified: 2015-12

Locations

US(4)