A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer
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ClinicalTrials.gov Identifier: NCT00732056 |
Recruitment Status :
Completed
First Posted : August 11, 2008
Last Update Posted : December 24, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: GRN163L | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I/II Study of GRN163L in Combination With Paclitaxel and Bevacizumab in Patients With Locally Recurrent or Metastatic Breast Cancer |
Study Start Date : | July 2008 |
Actual Primary Completion Date : | September 2011 |
Actual Study Completion Date : | March 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
3+3 cohort dose escalation
|
Drug: GRN163L
25% dose escalation infused over 2 hours weekly |
- Safety, MTD, efficacy [ Time Frame: First 4 weeks ]
- PK and efficacy [ Time Frame: Baseline to end of treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00732056
United States, Illinois | |
Ingalls Memorial Hospital | |
Harvey, Illinois, United States, 60426 | |
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | |
Indianapolis, Indiana, United States, 46202 |
Principal Investigator: | Kathy Miller, MD | Indiana University Melvin and Bren Simon Cancer Center |
Responsible Party: | Geron Corporation |
ClinicalTrials.gov Identifier: | NCT00732056 |
Other Study ID Numbers: |
GRN163L CP14A010 |
First Posted: | August 11, 2008 Key Record Dates |
Last Update Posted: | December 24, 2015 |
Last Verified: | December 2015 |
Metastatic Breast Cancer Recurrent Breast Cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |