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A Phase I Dose Escalation Study Evaluating Vintafolide (MK-8109) Chemotherapy Combinations in Adult Subjects With Advanced Cancers

Phase 1
18 Years
Open (Enrolling)
Advanced Cancer

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Trial Information

A Phase I Dose Escalation Study Evaluating Vintafolide (MK-8109) Chemotherapy Combinations in Adult Subjects With Advanced Cancers

Inclusion Criteria

Inclusion criteria for all participants:

- Histologically-confirmed metastatic or locally advanced solid tumor that has failed
to respond to standard therapy, progressed despite standard therapy, or for which
standard therapy does not exist or is unacceptable to the participant

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- At least one measurable metastatic or recurrent lesion

- No history of a previous malignancy with the exception of cervical intraepithelial
neoplasia, basal cell carcinoma of the skin, or adequately treated localized prostate
carcinoma; or has undergone potentially curative therapy with no evidence of disease
for five years

- Adequate organ function

- Female participants of childbearing potential must be willing to use acceptable
methods of birth control or abstain from heterosexual activity for the course of the
study through 30 days after the last dose of study therapy

- Male participants must agree to use an adequate method of contraception for
heterosexual activity starting with the first dose of study therapy through 90 days
after the last dose of study therapy

Inclusion criteria for Dose Confirmation Cohorts:

- Tumor lesions characterized as folate receptor (FR)+ or (FR)++

Inclusion criteria for Platinum-sensitive ovarian cancer participants:

- Histologically confirmed, non-low grade, non-borderline (low malignant potential)
ovarian, fallopian tube, or primary peritoneal cancer that has progressed after
paclitaxel / platinum-based therapy

- Platinum-sensitive disease. Progression must have occurred 6 months or more after the
completion of the most recent platinum-based treatment

- No biologic maintenance therapy (i.e., bevacizumab) or PARP inhibitor treatment
within 6 months or within 28 days prior to the start of study therapy.

- No more than two platinum containing regimens

Inclusion criteria for NSCLC participants:

- Histologically confirmed diagnosis of adenocarcinoma, adenosquamous carcinoma, or
adenocarcinoma with other NSCLC variants of the lung (Stage IIIb or IV)

- No more than two platinum containing regimens

Exclusion criteria for all participants:

- Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies)
within 4 weeks prior to drug administration, or not recovered from adverse events due
to agents administered more than 4 weeks earlier

- Currently participating or has participated in a study with an investigational
compound or device within 28 days of initial dosing on this study

- More than 3 prior cytotoxic regimens for metastatic disease.

- Primary central nervous system (CNS) tumor

- Active CNS metastases and/or carcinomatous meningitis.

- Known hypersensitivity to the components of the study therapy or its analogs

- Recent (i.e., ≤ 6 weeks) history of abdominal surgery or peritonitis

- Bowel occlusion or sub-occlusion

- Prior abdominal or pelvis 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 for the management of co-morbid conditions

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

- Pregnant or breastfeeding or expecting to conceive, or donate sperm within the span
of the study

- Human Immunodeficiency Virus (HIV)-positive

- Active Hepatitis B or C

- Symptomatic ascites or pleural effusion.

- History of stem cell or bone marrow transplant

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of participants with dose-limiting toxicities (DLTs)(Part 1)

Outcome Time Frame:

Cycle 1 (21 days)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2012

Completion Date:

March 2015

Related Keywords:

  • Advanced Cancer
  • Neoplasms



Call for Information (Investigational Site 0001)San Antonio, Texas  78229