Overview

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Withdrawn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.