Lung CancerPhase 1NCT00510445
Study of GRN163L With Paclitaxel and Carboplatin in Patients With Advanced or Metastatic Non Small Cell Lung Cancer
A Phase 1 study testing Imetelstat Sodium (GRN163L) in people with Lung Cancer, run by Geron Corporation at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Imetelstat Sodium (GRN163L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2007to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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)
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland Greenebaum Cancer Center
Baltimore, Maryland, 21201
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390
UT MD Anderson Cancer Center
Houston, Texas, 77030
University of Wisconsin, Paul P. Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792
About this study
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
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.
Read the detailed 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.
- Conditions
- Lung Cancer
- Being tested
- Imetelstat Sodium (GRN163L)
- Keywords
- Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Imetelstat Sodium (GRN163L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and MTD
Measured: First 3 weeks
Secondary outcomes (1)
PK and efficacy
Measured: Baseline to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00510445
- Sponsor's protocol ID
- GRN163L CP14A005
- Status last verified
- Dec 2015
- First submitted
- 31 Jul 2007
- Last updated
- 24 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00510445
- Acronym / sponsor ID
- GRN163L CP14A005
- Conditions
- Lung Cancer
- Keywords
- Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer, Metastatic Non Small Cell Lung Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Geron CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 2 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Trial | Experimental | Drug: Imetelstat Sodium (GRN163L)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Single Arm Trial |
Primary outcome
Safety and MTD
Time frame: First 3 weeks
1 secondary outcome
PK and efficacy
Time frame: Baseline to end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2015.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Imetelstat Sodium (GRN163L) in people with Lung Cancer, run by Geron Corporation at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and MTD (time frame: First 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2015.