A Study of Vintafolide (MK-8109) in Participants With Advanced Solid Tumor (MK-8109-011)

A Phase I Dose Escalation Study Evaluating MK-8109 (Vintafolide) in Japanese Subjects With Advanced Solid Tumor

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02049281

Enrollment

Registered

2014-01-30

Start date

2014-02-28

Completion date

2014-05-31

Last updated

2015-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Solid Tumor

Brief summary

This study will evaluate thrice weekly dosing with vintafolide to find the maximum tolerable dose. The primary study hypothesis is that administration of vintafolide to participants with advanced solid tumors will have acceptable safety and tolerability.

Interventions

DRUGVintafolide

Intravenous (IV) bolus, starting dose 1.4 mg, on Days 1, 3, 5, 15, 17, and 19 of each 28-day cycle for up to 6 cycles.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Adequate organ function

Exclusion criteria

* Chemotherapy, radiotherapy, or biological therapy (including monoclonal antibodies) within 4 weeks prior to drug administration (6 weeks for nitrosoureas or mitomycin C) or not recovered from adverse events due to agents administered more than 4 weeks earlier * 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 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 three years to the breast / sternum, head, or neck * Requires anti-folate therapy * Symptomatic ascites or pleural effusion * Prior stem cell or bone marrow transplant

Design outcomes

Primary

Measure	Time frame
Number of Participants Experiencing Dose-limiting Toxicities	Up to 28 days

Secondary

Measure	Time frame
Maximum Plasma Concentration (Cmax) of Vintafolide	Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
Area Under the Plasma Concentration-time Curve (AUC) for Vintafolide	Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose
Plasma Concentration of desacetylvinblastine hydrazide (DAVLBH)	Cycle 1, Day1 predose and at 2, 5, 10, 20, 30, 45, 60, 90 and 120 minutes post-dose

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026