Clinical trial · Interventional
Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck (Study P02530)
An Open-Label Phase 2 Study of Lonafarnib in Patients With Recurrent Squamous Cell Carcinoma of the Head and Neck
NCT00073450CI-TRIAL-00017585terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine the safety and efficacy of an oral Farnesyl Protein Transferase Inhibitor (Lonafarnib/SCH 6636) as a single agent in Adult Patients With Squamous Cell Carcinoma of the Head \& Neck and will help determine if further development is justified.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Squamous Cell | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Farnesyl Protein Transferase Inhibitor | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically proven squamous cell carcinoma of the head \& neck. * Age greater than or equal to 18. * ECOG performance status of 0 to 1 * Measurable malignant disease. * Patients that have failed at least one platinum-containing regimen and have received no more than three prior regimens and do not have other curative treatment options. * Patients must be at least 2 wks post surgery or radiation therapy * Patients must be at least 4 weeks post chemotherapy * Meets protocol requirements for specified laboratory values. * Written informed consent and cooperation of patient. * Appropriate use of effective contraception if of childbearing potential. * No investigational drugs of any type within 30 days prior to administration. Exclusion Criteria: * Prior exposure to farnesyl transferase inhibitors * Medical conditions that would interfere with taking oral medications. * Patients with significant QTc prolongation at baseline (\>500 msec.) * Pregnant or nursing women * Known HIV positivity or AIDS-related illness. * Concomitant chemotherapy, hormonal therapy, radiotherapy or immunotherapy * Patients with any signs of involvement of the dura, meninges, or brain. * Patients with squamous cell carcinoma of the nasopharynx * Patients who currently have other cancers or have been treated in the last 5 years for any other malignancy.
References
Publications (1)
- RESULTHanrahan EO, Kies MS, Glisson BS, Khuri FR, Feng L, Tran HT, Ginsberg LE, Truong MT, Hong WK, Kim ES. A phase II study of Lonafarnib (SCH66336) in patients with chemorefractory, advanced squamous cell carcinoma of the head and neck. Am J Clin Oncol. 2009 Jun;32(3):274-9. doi: 10.1097/COC.0b013e318187dd57. PMID 19433965