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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02049281
• Other study ID #: 8109-011
• Secondary ID: 142501
• Status: Terminated
• Phase: Phase 1
• First received: January 28, 2014
• Last updated: February 9, 2015
• Start date: February 2014
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Endocyte
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Endocyte

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Experiencing Dose-limiting Toxicities		Up to 28 days	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No