Safety and Efficacy Study of Vintafolide and Vintafolide Plus Paclitaxel Compared to Paclitaxel Alone in Participants With Triple Negative Breast Cancer (TNBC) (MK-8109-004)

• Status: Withdrawn
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to assess the efficacy and safety of vintafolide alone compared to vintafolide plus paclitaxel and paclitaxel alone in participants with with 100% positive folate receptor (FR) triple negative breast cancer (TNBC).

The primary hypothesis of this study is the vintafolide alone and/or vintafolide + paclitaxel will improve progression free survival (PFS) in participants with FR (100%) TNBC compared to paclitaxel alone.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Endocyte
• Treatments: Albumin-Bound Paclitaxel; Folic Acid; Paclitaxel; Vinca Alkaloids; Vitamin B Complex

Criteria

Inclusion Criteria:

• Female with histologically or cytologically confirmed estrogen receptor negative, progesterone receptor negative, human epidermal growth factor receptor 2 (HER-2) negative advanced breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.

• Has developed progressive disease following at least 1 (and not more than 4) prior chemotherapeutic regimens for breast cancer, which was administered for treatment of locally advanced, locally recurrent and/or metastatic disease. [At least 1 regimen must have included a taxane (e.g., paclitaxel, docetaxel) in any combination or order.]

• Has at least a single measurable target lesion on a radiological evaluation that is conducted no more than 4 weeks prior to beginning of study drug. (Measurable lesions should not have received prior radiation therapy.)

• Has not received chemotherapy for 4 weeks prior to the initiation of study drug and must have recovered to ≤Common Terminology Criteria for Adverse Events (CTCAE) grade 1 toxicities related to prior chemotherapies.

• Female participants of childbearing potential should have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study drug.

• Female participants of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 30 days after the last dose of study drug.

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

• Has no history of a prior malignancy with the exception of cervical intraepithelial neoplasia; basal cell carcinoma of the skin or has undergone potentially curative therapy with no evidence of that disease for 5 years.

• Has adequate organ function.

Exclusion Criteria:

• Has had chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to study drug administration or has not recovered (≤Grade 1 or baseline) from adverse experiences due to agents administered more than 4 weeks earlier.

• Is currently participating or has participated in a study with an investigational compound or device within 28 days of initial dosing on this study.

• Has received more than 4 prior cytotoxic regimens for metastatic disease. Adjuvant treatments would not count towards this criterion.

• Has a primary central nervous system (CNS) tumor.

• Has active CNS metastases and/or carcinomatous meningitis.

• Has had prior therapy with vinorelbine (Navelbine®) or vinca-containing compounds.

• Has known hypersensitivity to paclitaxel, docetaxel, other taxane therapies, drugs formulated with polyoxyethylated castor oil (Cremophor EL®), vinblastine, other vinca derived therapies, or their components or analogs.

• Has pre-existing neuropathy >Grade 2.

• Has a recent (i.e., ≤6 weeks) history of abdominal surgery or peritonitis.

• Has a bowel occlusion or sub-occlusion.

• Has had prior abdominal or pelvic radiation therapy, or radiation therapy to >10% of the bone marrow at any time in the past, or prior radiation therapy within the last 3 years to the breast/sternum, dermal lesions, head, or neck.

• Requires anti-folate therapy.

• Has known psychiatric or substance abuse disorders.

• Is a known regular user (including "recreational use") of any illicit drugs or had a recent history (within the last year) of drug or alcohol abuse.

• Is expecting to reproduce within the projected duration of the study, and women who are pregnant or breastfeeding.

• Is known to be Human Immunodeficiency Virus (HIV)-positive.

• Has known active Hepatitis B or C.

• Has symptomatic ascites or pleural effusion.

• Has had a prior stem cell or bone marrow transplant.