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Phase I/II Study of SGI-110 With Irinotecan Versus Regorafenib or TAS-102 in Metastatic Colorectal Cancer

NCT01896856 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2020-10-06

Study results available
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Summary

This is a phase I/II study of the combination of Guadecitabine (SGI-110) and previously treated metastatic colorectal cancer patients. This study will be conducted in two components. First, patients will be enrolled in a phase I study of SGI-110 combined with irinotecan in a standard 3+3 design. After the maximum tolerated dose (MTD) is determined, patients will subsequently be enrolled in a 2:1 randomized phase II study of SGI-110 and irinotecan versus the standard of care regorafenib or Lonsurf (TAS-102).

Conditions

  • Previously Treated Metastatic Colorectal Cancer

Interventions

DRUG

SGI-110 Dose Escalation

* Dose level 1 (DL1): 45 mg/m\^2 administered as a subcutaneous injection * Dose level 1G (DL1G): 45 mg/m\^2 administered as a subcutaneous injection + growth factor support * Dose level -1 (DL-1): 30 mg/m\^2 administered as a subcutaneous injection * Dose level -1G (DL-1G): 30 mg/m\^2 administered as a subcutaneous injection + growth factor support

DRUG

Regorafenib

160 mg taken orally

DRUG

TAS-102

35 mg/m\^2 taken orally

DRUG

SGI-110

45 mg/m\^2 administered as a subcutaneous injection

DRUG

Irinotecan

125 mg/m\^2 administered IV

Sponsors & Collaborators

  • Van Andel Research Institute

    collaborator OTHER

  • Astex Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    lead OTHER

Principal Investigators

  • Nilo Azad, MD · SKCCC at JHMI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-23
Primary Completion
2019-08-26
Completion
2019-08-26

Countries

  • United States
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT01896856 on ClinicalTrials.gov