Status:
COMPLETED
Phase 1 and 2 Study of PX-866 and Cetuximab
Lead Sponsor:
Cascadian Therapeutics Inc.
Conditions:
Incurable Metastatic Colorectal Carcinoma
Incurable Progressive, Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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...
Detailed Description
Phase 1 will determine the maximally tolerated or recommended dose of PX-866 to be given orally on Days 1-21 in combination with cetuximab 250 mg/m2 administered IV weekly on Days 1, 8, and 15 of a 21...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT01252628
Start Date
December 1 2010
End Date
January 1 2014
Last Update
May 16 2018
Active Locations (40)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham Hematology and Oncology Assocs.
Birmingham, Alabama, United States, 35223
2
University of Alabama Birmingham
Birmingham, Alabama, United States, 35249
3
Southwest Cancer Care
Escondido, California, United States, 92025
4
Monterey Bay Oncology
Monterey, California, United States, 93940