A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma

NCT04627961 | Unknown Phase 2

• 1 other identifier: NP01/05/19
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, non-randomised study including patients with EBER positive nasopharyngeal carcinoma with recurrent or metastatic disease not amenable to curative treatment, who have received at least 1 regimen of platinum containing chemotherapy.

Conditions

Metastatic Nasopharyngeal Carcinoma; Recurrent Nasopharyngeal Carcinoma

Keywords

TAS102; NPC

Outcome Measures

Primary Outcomes (1)

• Disease control rate

  As defined by complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks of assessment using RECIST 1.1.

  45 months

Secondary Outcomes (2)

• Progression free survival rate of patients

  45 months

• Best objective response rate

  45 months

Study Arms (1)

Patient

EXPERIMENTAL

Patients with EBER positive nasopharyngeal carcinoma with recurrent or metastatic disease

Drug: TAS-102

Interventions

TAS-102 DRUG

Eligible patients who consent to participate will receive oral TAS-102 bid for days 1-5 and 8-12 of a 28 day cycle.

Also known as: LONSURF

Patient

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant (or legally acceptable representative if applicable) provides written consent for the trial.
• Participants who are at least 21 years of age on the day of signing informed consent with histologically or cytologically confirmed diagnosis of non-keratinizing nasopharyngeal carcinoma (NPC) that has recurred at loco regional and/or distant sites will be enrolled in this study.
• Have measurable disease based on RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Have EBV-positive NPC by EBV-encoded small RNA in situ hybridization (EBER in situ hybridization \[ISH\]) assay. If EBV-positive status has been previously determined by EBER ISH assay, then no re-testing is required.
• Note: If EBV status by EBER ISH assay has not been previously determined, tumor tissue from archival tissue may be submitted for EBV determination.
• Received one or more lines of chemotherapy, which must include prior treatment with a platinum agent and must not be amenable to potentially curative radiotherapy or surgery.
• Willingness to donate blood for translational research studies.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Have an adequate organ function as defined in the following table (Table 1). Specimens must be collected within 10 days prior to the start of study treatment.
• Table 1 Adequate Organ Function Laboratory Values System Laboratory Value
• Hematological
• Absolute neutrophil count (ANC) \> 1.5x109/L
• Platelets ≥ 100 x109/L
• Hemoglobin ≥ 8.0 g/dL a
• Renal

You may not qualify if:

• Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.
• Note: Participants must have recovered from all AEs to previous therapies to ≤ Grade 1 or baseline. Participants with ≤ Grade 2 neuropathy may be eligible.
• Note: If participants received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
• Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to first dose of study treatment.
• Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
• Has a known history of active TB (Bacillus Tuberculosis).
• Has received prior radiotherapy within 2 weeks of start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease.
• Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
• Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, transitional cell carcinoma of urothelial cancer, or carcinoma in situ (e.g. breast or cervical carcinoma in situ) that have undergone potentially curative therapy are not excluded.
• Has known brain metastases or leptomeningeal metastases, whether treated or untreated. NOTE: Primary nasopharyngeal cancers that directly invade the skull base and extend into the infratemporal fossa (e) are not regarded as brain metastases and are not excluded.
• Has an active infection requiring systemic therapy.
• Has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
• Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

RECRUITING

Related Publications (2)

• An X, Wang FH, Ding PR, Deng L, Jiang WQ, Zhang L, Shao JY, Li YH. Plasma Epstein-Barr virus DNA level strongly predicts survival in metastatic/recurrent nasopharyngeal carcinoma treated with palliative chemotherapy. Cancer. 2011 Aug 15;117(16):3750-7. doi: 10.1002/cncr.25932. Epub 2011 Feb 11.

  PMID: 21319149 RESULT

• Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.

  PMID: 19097774 RESULT

MeSH Terms

Conditions

Nasopharyngeal Carcinoma

Interventions

trifluridine tipiracil drug combination

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Study Officials

• Boon Cher Goh

  National University Hospital, Singapore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Boon Cher Goh

CONTACT

6779 5555; phcgbc@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible patients who consent to participate will receive oral TAS-102 for days 1-5 and 8-12 of a 28 day cycle.

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: November 13, 2020
• Study Start: August 26, 2020
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 13, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)