Incurable Metastatic Colorectal Carcinoma Clinical Trial
Official title:
Phase 1/2 Study of PX-866 and Cetuximab
| Verified date | June 2015 |
| Source | Seattle Genetics, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 178 |
| Est. completion date | January 2014 |
| Est. primary completion date | November 2013 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Royal Victoria Regional Health Centre | Barrie | Ontario |
| Canada | Cross Cancer Institute | Edmonton | Alberta |
| Canada | Hôpital Charles-LeMoyne | Greenfield Park | Quebec |
| Canada | Cité de la Santé de Laval | Laval | Quebec |
| Canada | London Regional Cancer Program | London | Ontario |
| Canada | Maisonneuve-Rosemont Hospital Research Centre | Montreal | Quebec |
| Canada | Northeast Cancer Centre of Health Sciences North | Sudbury | Ontario |
| Canada | Thunder Bay Regional Health Sciences Centre | Thunder Bay | Ontario |
| Canada | British Columbia Cancer Agency - Vancouver Centre | Vancouver | British Columbia |
| United States | Peachtree Hematology-Oncology Consultants | Atlanta | Georgia |
| United States | University of Colorado Denver | Aurora | Colorado |
| United States | Center for Cancer and Blood Disorders | Bethesda | Maryland |
| United States | Birmingham Hematology and Oncology Assocs. | Birmingham | Alabama |
| United States | University of Alabama Birmingham | Birmingham | Alabama |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Saint Louis Cancer Care LLP | Bridgeton | Missouri |
| 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 | Eastern Colorado Health Care System - (Denver VA) | Denver | Colorado |
| United States | Rocky Mountain Cancer Centers | Denver | Colorado |
| United States | Karmanos Cancer Institute | Detroit | Michigan |
| United States | Southwest Cancer Care | Escondido | California |
| United States | Virginia Cancer Specialists, PC | Fairfax | Virginia |
| United States | Texas Oncology - Fort Worth | Fort Worth | Texas |
| United States | Integrated Community Oncology Network | Jacksonville | Florida |
| United States | Columbia Basin Hematology and Oncology | Kennewick | Washington |
| United States | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada |
| United States | Advanced Medical Specialties | Miami | Florida |
| United States | Monterey Bay Oncology | Monterey | California |
| United States | Pasco Pinellas Cancer Center | New Port Richey | Florida |
| United States | Peninsula Cancer Institute | Newport News | Virginia |
| United States | Virginia Oncology Associates | Newport News | Virginia |
| United States | Ventura County Hematology Oncology Specialists | Oxnard | California |
| United States | University of Pennsylvania | Philadelphia | Pennsylvania |
| United States | Oncology and Hematology Associates of Southwest Virginia | Roanoke | Virginia |
| United States | Texas Oncology - Seton Williamson | Round Rock | Texas |
| United States | Medical Oncology Associates | Spokane | Washington |
| United States | Northwest Cancer Specialists, P.C. | Tualatin | Oregon |
| United States | George Washington University - Medical Faculty Associates | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Cascadian Therapeutics Inc. |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The evaluation of antitumor effects of PX-866 in combination with cetuximab versus cetuximab in patients with incurable metastatic colorectal cancer and/or patients with incurable progressive, recurrent or metastatic SCC of the head and neck. | 21 days |