Breast CancerPhase 1NCT00732056
A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer
A Phase 1 study testing GRN163L in people with Breast Cancer, run by Geron Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to determine the maximum tolerated dose (MTD) of GRN163L in combination with paclitaxel and bevacizumab in patients with locally recurrent or metastatic breast cancer (MBC) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- GRN163L
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2008to Mar 2012
- 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 adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
- May have had one prior non-taxane chemotherapy regimen for metastatic disease
- If HER2 positive, must have had prior treatment with trastuzumab (Herceptin®)
- If previously treated with an anthracycline, anthracenedione, or trastuzumab must be tested by MUGA scan or echocardiogram and have LVEF ≥ 50%
- Must have recovered from most recent radiation treatment or surgical procedure
- ECOG performance status of 0 or 1
- Life expectancy ≥ 3 months
Who cannot join
- Locally recurrent disease amenable to resection with curative intent
- Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to first study drug administration
- Investigational therapy within 4 weeks prior to first study drug administration
- Prior hormonal therapy within 2 weeks prior to first study drug administration
- Prior radiotherapy within 2 weeks prior to first study drug administration
- Cytotoxic chemotherapy within 2 weeks prior to first study drug administration
Show all 28Show fewer
- Therapeutic anticoagulation or regular use of anti-platelet therapy within 2 weeks prior to first study drug administration NOTE: Low-dose anticoagulant therapy to maintain patency of a vascular access device is allowed.
- Prolongation of PT or INR, aPTT > ULN, or fibrinogen < LLN
- Active or chronically current bleeding (eg, active peptic ulcer)
- Clinically significant cardiovascular or cerebrovascular disease including
- Any history of:
- Cerebrovascular disease including TIA, stroke or subarachnoid hemorrhage
- Ischemic bowel
- Within the last 12 months:
- MI
- Unstable angina
- NYHA grade II or greater CHF
- Grade 2 or greater peripheral vascular disease
- Active at study entry:
- Uncontrolled hypertension defined as SBP > 160 or DBP > 90
- Uncontrolled or clinically significant arrhythmia
- Clinically relevant active infection
- Nonhealing wound or fracture
- Serious co-morbid medical conditions, including cirrhosis and chronic obstructive or chronic restrictive pulmonary disease
- Active autoimmune disease requiring immunosuppressive therapy
- Known positive serology for HIV
- Prior malignancy (within the last 3 years) except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, in situ breast cancer, or in situ prostate cancer, or other cancer for which the patient has been disease-free for at least 3 years
- Any other severe, acute, or chronic medical or psychiatric condition, laboratory abnormality, or difficult complying with protocol requirements that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ingalls Memorial Hospital
Harvey, Illinois, 60426
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
About this study
Official title: A Phase I/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
The purpose of this study is to determine the maximum tolerated dose (MTD) of GRN163L in combination with paclitaxel and bevacizumab in patients with locally recurrent or metastatic breast cancer (MBC)
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
- Breast Cancer
- Being tested
- GRN163L
- Keywords
- Metastatic Breast Cancer, Recurrent Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GRN163LDrug
25% dose escalation infused over 2 hours weekly
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3+3 cohort dose escalation Receives: Drug: GRN163L |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety, MTD, efficacy
Measured: First 4 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 posted11 Aug 2008 (estimated)
- Study startJul 2008
- Primary completionSep 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geron Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kathy Miller, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00732056
- Sponsor's protocol ID
- GRN163L CP14A010
- Status last verified
- Dec 2015
- First submitted
- 7 Aug 2008
- 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/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT00732056
- Acronym / sponsor ID
- GRN163L CP14A010
- Conditions
- Breast Cancer
- Keywords
- Metastatic Breast Cancer, Recurrent Breast Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Geron CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Sep 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 11 Aug 2008 (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 maximum tolerated dose (MTD) of GRN163L in combination with paclitaxel and bevacizumab in patients with locally recurrent or metastatic breast cancer (MBC)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: GRN163L3+3 cohort dose escalation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
- May have had one prior non-taxane chemotherapy regimen for metastatic disease
- If HER2 positive, must have had prior treatment with trastuzumab (Herceptin®)
- If previously treated with an anthracycline, anthracenedione, or trastuzumab must be tested by MUGA scan or echocardiogram and have LVEF ≥ 50%
- Must have recovered from most recent radiation treatment or surgical procedure
Key exclusion criteria (28 listed)
- Locally recurrent disease amenable to resection with curative intent
- Prior adjuvant or neoadjuvant taxane chemotherapy within 12 months prior to first study drug administration
- Investigational therapy within 4 weeks prior to first study drug administration
- Prior hormonal therapy within 2 weeks prior to first study drug administration
- Prior radiotherapy within 2 weeks prior to first study drug administration
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 |
|---|---|---|
| GRN163L25% dose escalation infused over 2 hours weekly | Drug | 1 |
Primary outcome
Safety, MTD, efficacy
Time frame: First 4 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.
Kathy Miller, MD principal investigator
Indiana University
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 GRN163L in people with Breast Cancer, 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 28 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, MTD, efficacy (time frame: First 4 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.