Taxane Therapy With or Without Bavituximab for the Treatment of HER2-Negative Metastatic Breast Cancer

NCT02651610 | Withdrawn Phase 2 DMC

• 2 other identifiers: PPHM 14012015-003780-11
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

The primary purpose of this research study is to see whether adding bavituximab (an investigational drug) to the standard chemotherapy drug taxane, will improve the results of the treatment for HER2-negative metastatic breast cancer.

Conditions

Metastatic Breast Cancer

Keywords

PPHM 1401; bavituximab; Peregrine; Breast Cancer; HER-2 Negative; HER2 Negative

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  24 months

Secondary Outcomes (5)

• Safety Measures - Adverse Events and Laboratory Evaluations

  24 months

• Efficacy: Disease Control Rate (DCR)

  24 Months

• Efficacy: Duration of Response (DOR)

  24 Months

• Efficacy: Progression Free Survival (PFS)

  24 Months

• Efficacy: Overall Survival

  24 Months

Study Arms (2)

Taxane

ACTIVE COMPARATOR

Docetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles

Drug: Taxane

Bavituximab plus taxane

EXPERIMENTAL

Bavituximab 3 mg/kg weekly PLUS Docetaxel on Day 1 of 21-day cycles OR Paclitaxel on Days 1, 8, and 15 of 28-day cycles

Biological: Bavituximab; Drug: Taxane

Interventions

Bavituximab BIOLOGICAL

Biological: bavituximab

Bavituximab plus taxane

Taxane DRUG

Drug: Taxane Other names: Paclitaxel. Taxotere, Taxotere, Docecad, Taxol

Also known as: Paclitaxel, Taxotere, Docetaxel, Docecad, Taxol

Bavituximab plus taxane; Taxane

Eligibility Criteria

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

You may qualify if:

• Written informed consent obtained prior to screening.
• Females or males at least 18 years of age.
• Histologically or cytologically documented metastatic HER2-negative breast cancer.
• Measurable disease per RECIST 1.1 (Phase II); evaluable disease (Phase III)
• ECOG performance status of 0 or 1.
• Adequate hematologic function: absolute neutrophil count ≥1500 cells/µL; hemoglobin ≥9 g/dL; platelets ≥100,000/µL.
• Adequate renal function: serum creatinine ≤1.8 mg/dL or calculated creatinine clearance \>50 mL/min using the Cockcroft-Gault equation.
• Adequate hepatic function: total bilirubin ≤ upper limit of normal (ULN), serum albumin ≥3.0 g/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN. ALT and/or AST may be ≤5 × ULN if due to liver metastases. If ALT or AST is \>1.5 and ≤5 × ULN in patients with liver metastases, alkaline phosphatase must be ≤2.5 × ULN. Patients with Gilbert's syndrome are allowed if total bilirubin is ≤2 × ULN and direct bilirubin is ≤ULN.
• Prothrombin time (PT) and/or international normalized ratio (INR) ≤1.5 × ULN and activated partial thromboplastin time (aPTT) ≤1.5 × ULN if patient is not on anticoagulant therapy (a therapeutic PT and/or INR and aPTT is acceptable if the patient is on anticoagulants).
• Patients must have a negative serum human chorionic gonadotropin test within 1 week of Day 1 (pregnancy test not required for patients with bilateral oophorectomy and/or hysterectomy or for those patients who are \>1 year postmenopausal).
• All patients of reproductive potential (ie, not surgically sterile or postmenopausal) must agree to use a highly effective method of contraception (\<1% failure rate per year) during and 3 months after end of study treatment (female) or during and 6 months after the end of study treatment (male).

You may not qualify if:

• HER2-positive breast cancer.
• Less than 6 months since last dose of prior adjuvant non-taxane regimen.
• Less than 12 months since last dose of prior adjuvant taxane-containing regimen.
• Any chemotherapy regimen for MBC within 3 weeks before Day 1.
• Known history of bleeding diathesis or coagulopathy (eg, von Willebrand disease or hemophilia).
• Bleeding:
• Clinically significant bleeding, such as gross hematuria, gastrointestinal bleeding, and hemoptysis within the 6 months before screening, unless the cause has been identified and adequately treated (eg, cystitis, ulcer).
• Minor biopsy-related bleeding lasting \<24 hours and resolved at least 1 week before Day 1 is allowed.
• Thromboembolic events (eg, deep vein thrombosis, pulmonary embolism, arterial thrombosis) within 6 months before screening.
• Grade 2 or higher peripheral neuropathy (eg, numbness, tingling, and/or pain in distal extremities).
• Radiotherapy within 1 week preceding Day 1; ongoing acute toxicity from prior radiotherapy.
• Either symptomatic or clinically active brain metastases (ie, requiring ongoing treatment). Patients are eligible if brain metastases are adequately treated. Patients must be either off corticosteroids, or on a stable or decreasing dose of ≤10 mg daily prednisone (or equivalent).
• Major surgery within 4 weeks of Day 1.
• Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease, active infections).
• Autoimmune disease, being treated with immunosuppressive drugs (eg, methotrexate or biological agents), or other conditions requiring immunosuppressive therapy (eg, prior allotransplantation).

Sponsors & Collaborators

• Peregrine Pharmaceuticals: lead

Study Sites (2)

Peregrine Pharmaceuticals Investigational Site

Bakersfield, California, 93309, United States

Location

Peregrine Pharmaceuticals Investigational Site

Tinley Park, Illinois, 60487, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

bavituximab; taxane; Paclitaxel; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Kathy Miller, MD

  Indiana University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2015
• First Posted: January 11, 2016
• Study Start: December 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: June 1, 2018
• Last Updated: July 11, 2017

Record last verified: 2017-07

Locations

US (2)