A Study of GRN163L With Paclitaxel and Bevacizumab to Treat Patients With Locally Recurrent Or Metastatic Breast Cancer

NCT00732056 | Completed Phase 1

• 1 other identifier: GRN163L CP14A010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Breast Cancer

Keywords

Metastatic Breast Cancer; Recurrent Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Safety, MTD, efficacy

  First 4 weeks

Secondary Outcomes (1)

• PK and efficacy

  Baseline to end of treatment

Study Arms (1)

1

EXPERIMENTAL

3+3 cohort dose escalation

Drug: GRN163L

Interventions

GRN163L DRUG

25% dose escalation infused over 2 hours weekly

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• Unstable angina

Sponsors & Collaborators

• Geron Corporation: lead

Study Sites (2)

Ingalls Memorial Hospital

Harvey, Illinois, 60426, United States

Location

Indiana University Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Breast Neoplasms

Interventions

GRN163L peptide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kathy Miller, MD

  Indiana University Melvin and Bren Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: July 1, 2008
• Primary Completion: September 1, 2011
• Study Completion: March 1, 2012
• Last Updated: December 24, 2015

Record last verified: 2015-12

Locations

US (2)