Solid Tumor MalignanciesPhase 1NCT00310895
Safety and Dose Study of GRN163L Administered to Patients With Refractory or Relapsed Solid Tumor Malignancies
A Phase 1 study testing Imetelstat Sodium (GRN163L) in people with Solid Tumor Malignancies, run by Geron Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to determine the safety and the maximum tolerated dose of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Malignancies
- What is being tested?
- Imetelstat Sodium (GRN163L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to Mar 2013
- 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
- 18 years of age or older
- Male or female
- Measurable or evaluable solid tumor malignancy
- Relapsed, refractory, locally advanced, or metastatic disease
- Disease refractory to or not amenable to standard therapy
- Karnofsky performance status 70-100%
- Life expectancy 3 months or greater
Who cannot join
- Pregnant or lactating women
- Primary central nervous system(CNS) malignancy or active CNS metastases
- Hematologic malignancy
- Chemotherapy within 4 weeks prior to study
- Mitomycin C, nitrosoureas within 6 weeks prior to study
- High dose chemotherapy with stem cell support within 6 months prior to study
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- Signal transduction inhibitors, monoclonal antibodies, etc. within 4 weeks prior to study
- Systemic hormonal therapy within 4 weeks prior to study
- Anticoagulant therapy, antiplatelet therapy within 2 weeks prior to study
- Radiotherapy within 4 weeks prior to study
- Significant cardiovascular disease
- Serious/active infection
- Major surgical procedures within 2 weeks
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The University of Chicago Medical Center
Chicago, Illinois, 60637
Wayne State University, Karmanos Cancer Center
Detroit, Michigan, 48201
About this study
Official title: A Phase I, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies
The purpose of this study is to determine the safety and the maximum tolerated dose of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.
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
- Solid Tumor Malignancies
- Being tested
- Imetelstat Sodium (GRN163L)
- Keywords
- Refractory, Relapsed
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imetelstat Sodium (GRN163L)Drug
Dose increase by 25% if tolerated infused over 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Treatment Schedule 3 will consist of dosing on Days 1, 4, 8, and 11 of each 21 day cycle (3 weeks equals 1 cycle) and Treatment Schedule 4 will consist of dosing on Day 1 of each 28 day cycle (4 weeks equals 1 cycle) Receives: Drug: Imetelstat Sodium (GRN163L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, DLT, and MTD
Measured: Measured during the first cycle of treatment
Secondary outcomes (1)
PK profile and disease response
Measured: Within the first 2 cycles of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor MalignanciesStudies 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
- 85 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Geron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00310895
- Sponsor's protocol ID
- GRN163L CP05-101
- Status last verified
- Dec 2015
- First submitted
- 4 Apr 2006
- 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, Sequential Cohort, Dose Escalation Trial to Determine the Safety, Tolerability, and MTD of GRN163L in Patients With Refractory or Relapsed Solid Tumor Malignancies
- ClinicalTrials.gov ID
- NCT00310895
- Acronym / sponsor ID
- GRN163L CP05-101
- Conditions
- Solid Tumor Malignancies
- Keywords
- Refractory, Relapsed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (estimated)
- Lead sponsor
- Geron CorporationIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 5 Apr 2006 (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 of GRN163L administration in treating patients with refractory or relapsed solid tumor malignancies.
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 |
|---|---|---|
| Dose escalation | Experimental | Drug: Imetelstat Sodium (GRN163L)Treatment Schedule 3 will consist of dosing on Days 1, 4, 8, and 11 of each 21 day cycle (3 weeks equals 1 cycle) and Treatment Schedule 4 will consist of dosing on Day 1 of each 28 day cycle (4 weeks equals 1 cycle) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years of age or older
- Male or female
- Measurable or evaluable solid tumor malignancy
- Relapsed, refractory, locally advanced, or metastatic disease
- Disease refractory to or not amenable to standard therapy
Key exclusion criteria (13 listed)
- Pregnant or lactating women
- Primary central nervous system(CNS) malignancy or active CNS metastases
- Hematologic malignancy
- Chemotherapy within 4 weeks prior to study
- Mitomycin C, nitrosoureas within 6 weeks prior to study
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)Dose increase by 25% if tolerated infused over 2 hours | Drug | Dose escalation |
Primary outcome
Safety, DLT, and MTD
Time frame: Measured during the first cycle of treatment
1 secondary outcome
PK profile and disease response
Time frame: Within the first 2 cycles 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.
2 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 Solid Tumor Malignancies, run by Geron Corporation at 2 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 7 inclusion and 13 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 2 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, DLT, and MTD (time frame: Measured during the first cycle of treatment). 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.