Nasopharyngeal Carcinoma (NPC) Axitinib
This study is currently recruiting participants.
Verified December 2013 by Chinese University of Hong Kong
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
First received: November 29, 2010
Last updated: December 17, 2013
Last verified: December 2013
This is an open-label, single arm, phase 2 clinical trial evaluating the activity and safety of single-agent axitinib in recurrent or metastatic NPC patients who failed at least one line of platinum based chemotherapy.
Recurrent or Metastatic NPC
||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma
Primary Outcome Measures:
- To evaluate the efficacy (clinical benefit rate) of single-agent axitinib in patients with recurrent or metastatic NPC, and its impact on disease progression. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To assess objective response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To assess duration of response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To assess progression-free survival [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
- To assess overall survival [ Time Frame: 3 Years ] [ Designated as safety issue: No ]
- To evaluate the safety and tolerability of axitinib [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- To evaluate axitinib plasma pharmacokinetics and to correlate these plasma concentrations with efficacy and safety parameters [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- To study blood and tissue biomarkers and correlate with cancer- and treatment-related outcomes [ Time Frame: 3 years ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
Experimental: axitinib arm
starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- Histologically confirmed diagnosis of nasopharyngeal carcinoma (NPC) (either at initial diagnosis or at recurrence).
- Patients with recurrent or metastatic NPC that has progressed following one line of prior platinum-based chemotherapy.
- Disease must be not amenable to potentially curative radiotherapy or surgery.
- Measurable disease according to RECIST.
- Age 18 or above; ECOG performance 0 or 1.
- Adequate bone marrow, renal and hepatic reserve.
- Presence of local recurrence
- Presence of neck lymph node recurrence invading vascular structure;
- Presence of central lung lesions involving major blood vessels;
- History of hemoptysis or epistaxis within 4 weeks;
- Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite adequate medical therapy;
- Gastrointestinal abnormalities, including inability to take oral medication or malabsorption syndrome;
- Concurrent use or anticipated need for treatment with known potent CYP3A4 inhibitors or CYP3A4 /CYP1A2 inducers.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249547
|Department of Clinical Oncology, Prince of Wales Hospital
|Hong Kong, Hong Kong |
|Contact: Anthony TC Chan, MD, FRCP 2632 2119 email@example.com |
|Contact: Rosalie HO, RN 2632 1135 firstname.lastname@example.org |
|Principal Investigator: Edwin Hui, FRCP |
Chinese University of Hong Kong
||Anthony TC Chan, MD, FRCP
||Department of Clinical Oncology, The Chinese University of Hong Kong
No publications provided
||CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 29, 2010
||December 17, 2013
||Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on March 06, 2014
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Head and Neck Neoplasms
Neoplasms by Site