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

NCT02049281 | Terminated Phase 1

• 2 other identifiers: 8109-011142501
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Number of Participants Experiencing Dose-limiting Toxicities

  Up to 28 days

Secondary Outcomes (3)

• 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

Study Arms (1)

Vintafolide

EXPERIMENTAL

Participants receive vintafolide 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.

Drug: Vintafolide

Interventions

Vintafolide DRUG

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.

Also known as: MK-8109

Vintafolide

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Endocyte: lead

MeSH Terms

Interventions

EC145

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 28, 2014
• First Posted: January 30, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 10, 2015

Record last verified: 2015-02