A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma

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Brief Title

A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma

Official Title

A Phase 2 Trial of TAS 102 in Recurrent/Metastatic Nasopharyngeal Carcinoma

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.
    

Detailed Description

      HYPOTHESIS

      Given the favourable activity of fluoropyrimidines (5Fluorouracil) which inhibit thymidylate
      synthase (TS) in nasopharyngeal carcinoma, the investigators hypothesized that TAS-102 may
      demonstrate efficacy in NPC through targeting TS as well as an additional mechanism of
      incorporating trifluridine triphosphate into DNA.

      OBJECTIVES OF TRIAL

        1. To determine the clinical efficacy of TAS-102 in recurrent and metastatic NPC

        2. To assess the safety and tolerability of TAS-102 in the study population of R/M NPC

        3. To study the pharmacokinetics of TAS-102 in the study population of R/M NPC

        4. To study potential predictive biomarkers for clinical benefit from TAS-102
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Disease control rate

Secondary Outcome

 Progression free survival rate of patients

Condition

Metastatic Nasopharyngeal Carcinoma

Intervention

TAS-102

Study Arms / Comparison Groups

 Patient
Description:  Patients with EBER positive nasopharyngeal carcinoma with recurrent or metastatic disease

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

33

Start Date

August 26, 2020

Completion Date

October 2024

Primary Completion Date

October 2024

Eligibility Criteria

        Inclusion Criteria:

          1. The participant (or legally acceptable representative if applicable) provides written
             consent for the trial.

          2. 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.

          3. 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.

          4. 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.

          5. 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.

          6. Willingness to donate blood for translational research studies.

          7. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

          8. 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

                    1. Absolute neutrophil count (ANC) > 1.5x109/L

                    2. Platelets ≥ 100 x109/L

                    3. Hemoglobin ≥ 8.0 g/dL a

               -  Renal

                  a) Serum creatinine ≤ 1.5 X upper limit of normal (ULN) OR measured or calculated
                  creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≥ 30
                  mL/min for participants with creatinine levels > 1.5X ULN

               -  Hepatic

                    1. Serum total bilirubin (Tbil) < 1.5 X ULN EXCEPT Patients with Gilbert's
                       Syndrome, who can have Tbil < 3.0 mg/dL

                    2. AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver
                       metastases

               -  Coagulation

                    1. International Normalized Ratio (INR) OR prothrombin time (PT) ≤ 1.5X ULN
                       unless participant is receiving anticoagulant therapy as long as PT or aPTT
                       is within therapeutic range of intended use of anticoagulants

                    2. Activated partial thromboplastin time (aPTT) ≤ 1.5X ULN unless participant
                       is receiving anticoagulant therapy as long as PT or aPTT is within
                       therapeutic range of intended use of anticoagulants ALT (SGPT)=alanine
                       aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate
                       aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular
                       filtration rate; ULN=upper limit of normal.

          9. A female participant is eligible to participate if she is not pregnant, not
             breastfeeding, and at least one of the following conditions applies:

               1. Not a woman of childbearing potential (WOCBP) OR

               2. A WOCBP who agrees to follow the contraceptive guidance during the treatment
                  period and for at least 120 days after the last dose of study medication.

         10. A male participant must agree to use a contraception during the treatment period and
             for at least 120 days after the last dose of study treatment and refrain from donating
             sperm during this period.

        Exclusion Criteria:

          1. 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.

          2. 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.

          3. Has a known history of active TB (Bacillus Tuberculosis).

          4. 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.

          5. 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.

          6. 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.

          7. Has an active infection requiring systemic therapy.

          8. 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.

          9. 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.

         10. Has known psychiatric or substance abuse disorders that would interfere with
             cooperation with the requirements of the trial.

         11. 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.

         12. A WOCBP who has a positive urine pregnancy test within 72 hours prior to
             randomization/allocation (see Appendix 3). If the urine test is positive or cannot be
             confirmed as negative, a serum pregnancy test will be required.

        Note: In the event that 72 hours have elapsed between the screening pregnancy test and the
        first dose of study treatment, another pregnancy test (urine or serum) must be performed
        and must be negative in order for subject to start receiving study medication.
      

Gender

All

Ages

21 Years - 99 Years

Accepts Healthy Volunteers

No

Contacts

Boon Cher Goh, 6779 5555, [email protected]

Location Countries

Singapore

Location Countries

Singapore

Administrative Informations


NCT ID

NCT04627961

Organization ID

NP01/05/19


Responsible Party

Sponsor

Study Sponsor

National University Hospital, Singapore


Study Sponsor

Boon Cher Goh, Principal Investigator, National University Hospital, Singapore


Verification Date

November 2020