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An Extended Feasibility Phase I/II Study of Methylenetetrahydrofolate (Arfolitixorin) and Pemetrexed Single Agent, Given as Neoadjuvant Treatment in Patients With Resectable Rectal Cancer

NCT01397305 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-09-09

No results posted yet for this study

Summary

The purpose of this study is to determine whether an optimal dose of \[6R\] 5,10-methylenetetrahydrofolate (arfolitixorin) in combination with pemetrexed are effective in pre-operative treatment of patients with resectable rectal cancer.

Conditions

Interventions

DRUG

[6R] 5,10-methylenetetrahydrofolate (arfolitixorin)

10, 50, 100, 200, and 500 mg/m2 IV on day 1, day 8 day and day 15 of each 21-day cycle. 3 cycles.

DRUG

Pemetrexed

500 mg/m2 IV on day 1 of each 21-day cycle. 3 cycles.

Sponsors & Collaborators

  • Isofol Medical AB

    lead INDUSTRY

Principal Investigators

  • Bengt G Gustavsson, PhD, MD · Sahlgrenska University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-14
Primary Completion
2014-10-16
Completion
2014-10-16

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01397305 on ClinicalTrials.gov