Ph Ib/IIa Study of Cabazitaxel Plus Bavituximab in Castration-resistant Prostate Cancer

NCT01335204 | Terminated Phase 1 Results DMC

• 3 other identifiers: MUSC 101637HS#2011-8083NCI-2011-01248
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase Ib/IIa Study of Cabazitaxel plus Bavituximab in patients with castration-resistant prostate cancer (CRPC). The current study is designed to determine if the addition of bavituximab to cabazitaxel will improve progression free survival (PFS) or overall survival (OS). In addition, the Lead Researcher is requiring the collection of urine, and blood specimens for future research. This study will enroll patients with CRPC, who have been previously treated with docetaxel or a docetaxel-containing regimen. Patients may be intolerant of, or resistant to, docetaxel, or may have been previously treated with the agent without definite disease progression during therapy. Patients must meet the study eligibility criteria and must be competent to give informed consent.

Conditions

Prostate Cancer; Prostatic Neoplasms

Keywords

Castration-resistant prostate cancer; Prostate Cancer; JEVTANA; Cabazitaxel; Bavituximab

Outcome Measures

Primary Outcomes (1)

• Probability of Progression-free Survival at Day 85

  The primary objective of this study is to determine the probability of progression-free survival (PFS) after 12 weeks of therapy in subjects with CRPC treated with cabazitaxel + bavituximab.

  12 weeks

Secondary Outcomes (5)

• Measurement of PSA Response Rate

  24 weeks

• Objective Response Rate by RECIST for Patients With Measurable Disease

  24 weeks

• Overall Survival

  24+ weeks

• Number of With Grade 3 or 4 Toxicities

  24 weeks

• Progression-free Survival (PFS)

  24+ weeks

Study Arms (1)

Cabazitaxel plus bavituximab

EXPERIMENTAL

Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle. Bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.

Drug: Cabazitaxel plus bavituximab

Interventions

Cabazitaxel plus bavituximab DRUG

Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.

Also known as: JEVTANA® (cabazitaxel)

Cabazitaxel plus bavituximab

Eligibility Criteria

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

You may qualify if:

• Written informed consent has been obtained.
• Adults 18 years of age or older with a life expectancy of at least 3 months.
• Histologically confirmed castration-resistant prostate cancer (CRPC). Patient must have demonstrated a rising PSA level above the androgen-deprivation therapy (ADT) nadir, on at least two determinations four weeks or more apart. ADT is defined as treatment with a Luteinizing-hormone-releasing hormone (LHRH) agonist or orchiectomy.
• Treatment with only one prior chemotherapy regimen, which must contain docetaxel as a single agent or in combination with other agents. Patients may be intolerant of, or resistant to, the cytotoxic drug combination.
• Patients on ADT must be willing to continue ADT for the duration of their participation in this protocol. ADT cannot be initiated, and ADT dose/agents may not be changed during the study.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Adequate hematologic function (absolute neutrophil count \[ANC\] ≥ 1,500 cells/μL; hemoglobin ≥ 8 g/dL, platelets ≥ 100,000/μL).
• Adequate renal function (serum creatinine ≤ 1.5 mg/dL or calculated creatinine clearance ≥ 60 mL/min).
• Adequate hepatic function (bilirubin ≤ 1.0 x upper limit of normal \[ULN\], alanine aminotransferase \[ALT\] ≤ 1.5 x ULN, aspartate aminotransferase \[AST\] ≤ 1.5 x ULN).
• Prothrombin time (PT) / international normalized ratio (INR) ≤ 1.5 × ULN.
• Activated partial thromboplastin (aPTT) time ≤ 1.5 × ULN.
• Prostate-specific antigen (PSA) level of at least 2 ng/mL.
• New York Heart Association classification I or II.
• All patients of reproductive potential must agree to use an approved form of contraception (as determined by the investigator).

You may not qualify if:

• Known history of bleeding diathesis or coagulopathy (e.g., von Willebrand disease or hemophilia).
• Any history of thromboembolic events (e.g., deep vein thrombosis or pulmonary thromboembolism); central venous catheter-related thrombosis \> 6 months before Screening is allowed.
• Ongoing therapy with oral or parenteral anticoagulants; patients on low-dose anticoagulants to maintain patency of central venous catheters are eligible.
• Grade 2 or higher peripheral neuropathy (e.g., numbness, tingling, and/or pain in distal extremities).
• Radiotherapy (teletherapy or brachytherapy) , chemotherapy or estrogen agonist within 28 days before Study Day 1.
• Systemic radiotherapy (Sm-153, Sr-89) within 56 days before study day 1.
• Symptomatic or clinically active brain metastases.
• Major surgery within 28 days of Study Day 1.
• Uncontrolled intercurrent disease (eg, diabetes, hypertension, thyroid disease).
• Any history of cerebrovascular accident, or transient ischemic attack at any time, or history of symptomatic coronary artery disease \< 6 months before screening.
• A history of any condition requiring anti-platelet therapy (eg, phosphodiesterase inhibitors, adenosine diphosphate receptor antagonists), with the exception of general cardiovascular prophylaxis with aspirin (≤ 325 mg/day).
• Serious non-healing wound (including wound healing by secondary intention, ulcer, or bone fracture).
• Known chronic infection with human immunodeficiency virus (HIV) or viral hepatitis.
• Contraindication to intravenous (IV) contrast media.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Peregrine Pharmaceuticals: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

cabazitaxel; bavituximab

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Kate Anderton
• Organization: Medical University of South Carolina

anderton@musc.edu

843-792-2708

Study Officials

• Michael Lilly, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: April 11, 2011
• First Posted: April 14, 2011
• Study Start: June 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: July 13, 2018
• Results First Posted: July 13, 2018

Record last verified: 2018-06

Locations

US (1)