Status:
COMPLETED
Caphosol in Oral Mucositis Due to Targeted Therapy
Lead Sponsor:
Impaqtt Foundation
Collaborating Sponsors:
CB Boers ORG
Memorial Sloan Kettering Cancer Center
Conditions:
Oral Complaints
Renal Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Targeted therapies such as multi-targeted tyrosine kinase inhibitors (TKI) and mammalian target of rapamycin inhibitors (mTORI) in renal cell carcinoma (RCC), demonstrate a high level of efficacy with...
Detailed Description
OM with mucosal change, associated pain, and taste change - are clinically relevant toxicities of TKI's and mTORI's presently in use. The incidence of oral mucositis of any grade is for sunitinib 38%,...
Eligibility Criteria
Inclusion
- Male and female subjects
- ≥18 years of age
- Histological proof of RCC, HCC or GIST
- Oral adverse events \> grade 0 due to sunitinib, sorafenib, pazopanib, temsirolimus, or everolimus in mono therapy at study entry
- Written informed consent
- Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
- Able to perform oral rinsing
- Able to complete questionnaires by themselves or with assistance
Exclusion
- Any previous systemic antineoplastic treatment within 4 weeks of initiation of current targeted anticancer therapy
- Current antineoplastic combination cytotoxic chemotherapy therapy
- Physiologic condition that precludes the use of an oral rinse
- Hypersensitivity to Caphosol ingredients
- Use of palifermin, oral cryotherapy, low level laser therapy, topical oral steroids within 3 weeks of current targeted anticancer therapy
- Oral abnormalities defined as baseline oral assessment of NCI-CTCAE v4.0 grade \> 0
- Current use of agents that are known to be strong inducers or inhibitors of CYP3A4 that can not be stopped
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2015
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT01265810
Start Date
November 1 2011
End Date
October 1 2015
Last Update
November 13 2017
Active Locations (2)
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1
The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
2
Leiden University Medical Centre (LUMC)
Leiden, Netherlands, 2300 RC