Phase 1 and 2 Study of PX-866 and Cetuximab

Completed · Phase 1/Phase 2

Conditions studied: Incurable Metastatic Colorectal Carcinoma, Incurable Progressive, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

In brief

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).

Key facts

Study ID: NCT01252628
Run by: Cascadian Therapeutics Inc.
People needed: 178
Starts: 2010-12-01
Expected to finish: 2014-01-01
Last updated by the study team: 2018-05-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

At least 18 years at time of consent
Use of a medically accepted form of contraception from the time of consent to completion of all follow-up study visits
If female of child-bearing potential, negative pregnancy test
Signed an informed consent
Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST)
Documentation available for last prior systemic treatment including dates of treatment, best response to treatment, duration of best response, and reason for discontinuation of treatment
Eastern Cooperative Oncology Group (ECOG) 0 or 1
Group 1: Patients with incurable metastatic CRC with a history of progression or recurrence following prior irinotecan and oxaliplatin containing regimens. Patients who have a history of intolerance of irinotecan based therapy or ineligibility to receive irinotecan are also eligible as long as they have received a prior oxaliplatin containing regimen.
Group 2: Patients with incurable SCCHN with a history of progression or recurrence following at least one prior platinum based chemotherapy or chemotherapy/radiation containing regimen. Patients who have a history of intolerance of platinum based therapy or history of ineligibility to receive a platinum based regimen are also eligible. SCCHN patients who received cetuximab as a radiosensitizer for locally advanced disease and completed treatment at least 6 months prior to start of study drug treatment are eligible
In the opinion of the clinical investigator, life expectancy of greater than 3 months
Adequate hematologic function
Adequate hepatic function
Creatinine level ≤1.5 x ULN
Serum magnesium ≥ LLN.

You may not qualify if…

Has medical, social, or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
Is breastfeeding
Treatment with any systemic chemotherapy, epidermal growth factor receptor (EGFR) inhibitor, radiation or experimental agent within 4 weeks of study drug dosing
Received prior cetuximab, except as defined in inclusion criteria
Previous treatment with a phosphatidylinositol 3-kinase (PI-3K) inhibitor
Known human immunodeficiency virus (HIV)
Poorly controlled diabetes mellitus (IFCC-HbA1C ≥ 53 mmol/mol or DCCT -HbA1C ≥ 7%)
Kras mutation in codon 12 or 13 (CRC patients only)
Known or suspected clinically active brain metastases. Previously treated and stable brain metastases are allowable. Stable brain metastases are defined as no change on CT scan or MRI for minimum of two months AND no change in steroid dose for a minimum of four weeks, unless change due to intercurrent infection or other acute event)
Any other significant medical or psychiatric condition that in the opinion of the investigator renders the patient inadequate for participation
History of severe hypersensitivity to cetuximab

Where it is running

Birmingham Hematology and Oncology Assocs. — Birmingham, Alabama, United States
University of Alabama Birmingham — Birmingham, Alabama, United States
Southwest Cancer Care — Escondido, California, United States
Monterey Bay Oncology — Monterey, California, United States
Ventura County Hematology Oncology Specialists — Oxnard, California, United States
University of Colorado Denver — Aurora, Colorado, United States
Rocky Mountain Cancer Centers — Denver, Colorado, United States
Eastern Colorado Health Care System - (Denver VA) — Denver, Colorado, United States
George Washington University - Medical Faculty Associates — Washington D.C., District of Columbia, United States
Integrated Community Oncology Network — Jacksonville, Florida, United States
Advanced Medical Specialties — Miami, Florida, United States
Pasco Pinellas Cancer Center — New Port Richey, Florida, United States
Peachtree Hematology-Oncology Consultants — Atlanta, Georgia, United States
Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
Tufts Medical Center — Boston, Massachusetts, United States
Karmanos Cancer Institute — Detroit, Michigan, United States
Saint Louis Cancer Care LLP — Bridgeton, Missouri, United States
Comprehensive Cancer Centers of Nevada — Las Vegas, Nevada, United States
Northwest Cancer Specialists, P.C. — Tualatin, Oregon, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
MUSC Hollings Cancer Center — Charleston, South Carolina, United States
Mary Crowley Cancer Center — Dallas, Texas, United States
Texas Oncology - Baylor Charles A. Sammons — Dallas, Texas, United States
Texas Oncology - Fort Worth — Fort Worth, Texas, United States
Texas Oncology - Seton Williamson — Round Rock, Texas, United States

Full record on ClinicalTrials.gov

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