MedTrace Logo

Phase 1 and 2 Study of PX-866 and Cetuximab

NCT01252628 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2018-05-16

No results posted yet for this study

Summary

The purpose of this Phase 1/2 open-label study is to determine the safety and efficacy of a cetuximab and PX-866 combination treatment. In the Phase 1 part of the study, the dose of PX-866 to be given in combination with cetuximab will be determined in patients with incurable metastatic CRC or incurable progressive, recurrent or metastatic SCCHN. The Phase 2 part of the study is a randomized evaluation of the antitumor activity and safety of PX-866 in combination with cetuximab versus cetuximab alone in patients with either incurable metastatic CRC who have a history of progression or recurrence following prior irinotecan and oxaliplatin containing regimens or are intolerant of irinotecan (Group 1) or incurable progressive, recurrent or metastatic SCCHN (Group 2).

Conditions

  • Incurable Metastatic Colorectal Carcinoma
  • Incurable Progressive, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

PX-866 (SCCHN)

PX-866 administered at the MTD/RD in combination in patients administered weekly on a 21 day cycle.

DRUG

Cetuximab (SCCHN)

Cetuximab administered weekly on a 21 day cycle, as standard of care in patients.

DRUG

PX-866 (CRC)

PX-866 administered at the MTD/RD in combination in patients administered weekly on a 21 day cycle.

DRUG

Cetuximab (CRC)

Cetuximab administered weekly on a 21 day cycle in patients, as standard of care.

Sponsors & Collaborators

  • Cascadian Therapeutics Inc.

    lead INDUSTRY

Principal Investigators

  • Diana Hausman, MD · Cascadian Therapeutics Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2013-11-30
Completion
2014-01-31

Countries

  • United States
  • Canada

Study Locations

More Related Trials

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 NCT01252628 on ClinicalTrials.gov