Nasopharyngeal Carcinoma (NPC) Axitinib
This study is currently recruiting participants.
Verified December 2012 by Chinese University of Hong Kong
Sponsor:
Chinese University of Hong Kong
Information provided by (Responsible Party):
CCTU, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01249547
First received: November 29, 2010
Last updated: December 11, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Recurrent or Metastatic NPC |
Drug: axitinib |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 2 Study of Axitinib in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma |
Resource links provided by NLM:
Further study details as provided by Chinese University of Hong Kong:
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: | 37 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: axitinib arm |
Drug: axitinib
starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249547
Contacts
| Contact: Anthony TC Chan, MD, FRCP | 26322119 | anthonytcchan@cuhk.edu.hk |
| Contact: Rosalie HO, RN | 26321135 | rosalie@clo.cuhk.edu.hk |
Locations
| Hong Kong | |
| Department of Clinical Oncology, Prince of Wales Hospital | Recruiting |
| Hong Kong, Hong Kong | |
| Contact: Anthony TC Chan, MD, FRCP 2632 2119 anthonytcchan@cuhk.edu.hk | |
| Contact: Rosalie HO, RN 2632 1135 rosalie@clo.cuhk.edu.hk | |
| Principal Investigator: Edwin Hui, FRCP | |
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
| Principal Investigator: | Anthony TC Chan, MD, FRCP | Department of Clinical Oncology, The Chinese University of Hong Kong |
More Information
No publications provided
| Responsible Party: | CCTU, Comprehensive Clinical Trial Unit, Chinese University of Hong Kong |
| ClinicalTrials.gov Identifier: | NCT01249547 History of Changes |
| Other Study ID Numbers: | NPC022 |
| Study First Received: | November 29, 2010 |
| Last Updated: | December 11, 2012 |
| Health Authority: | Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee |
Additional relevant MeSH terms:
|
Carcinoma Nasopharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms |
Head and Neck Neoplasms Neoplasms by Site Nasopharyngeal Diseases Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013