Metastatic Nasopharyngeal CarcinomaPhase 2NCT04627961
A Trial of LONSURF in Recurrent/Metastatic Nasopharyngeal Carcinoma
A Phase 2 study testing TAS-102 in people with Metastatic Nasopharyngeal Carcinoma and Recurrent Nasopharyngeal Carcinoma, run by National University Hospital, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Metastatic Nasopharyngeal Carcinoma, Recurrent Nasopharyngeal Carcinoma
- What is being tested?
- TAS-102
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteSingapore
- Study dates
- 26 Aug 2020to Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- 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
- Serum total bilirubin (Tbil) < 1.5 X ULN EXCEPT Patients with Gilbert's Syndrome, who can have Tbil < 3.0 mg/dL
- AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
- Coagulation
- 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
- 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.
- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- 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.
- 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.
Who cannot join
- 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).
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore
Boon Cher Goh, 65-6772-4617, Boon_Cher_Goh@nuhs.com.sg
About this study
Official title: A Phase 2 Trial of TAS 102 in Recurrent/Metastatic Nasopharyngeal Carcinoma
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.
Read the 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
- To determine the clinical efficacy of TAS-102 in recurrent and metastatic NPC
- To assess the safety and tolerability of TAS-102 in the study population of R/M NPC
- To study the pharmacokinetics of TAS-102 in the study population of R/M NPC
- To study potential predictive biomarkers for clinical benefit from TAS-102
- Being tested
- TAS-102
- Keywords
- TAS102, NPC
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAS-102Drug
Also called LONSURF
Eligible patients who consent to participate will receive oral TAS-102 bid for days 1-5 and 8-12 of a 28 day cycle.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Patients with EBER positive nasopharyngeal carcinoma with recurrent or metastatic disease Receives: Drug: TAS-102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease control rate
As defined by complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks of assessment using RECIST 1.1.
Measured: 45 months
Secondary outcomes (2)
Progression free survival rate of patients
as defined as the time from initiation of treatment to radiological progression, clinical deterioration or death.
Measured: 45 months
Best objective response rate
as assessed by RECIST 1.1
Measured: 45 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start26 Aug 2020
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metastatic Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Eligible patients who consent to participate will receive oral TAS-102 for days 1-5 and 8-12 of a 28 day cycle.
- Masking
- None (open label)
- Enrolment
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Boon Cher Goh, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627961
- Sponsor's protocol ID
- NP01/05/19
- Status last verified
- Nov 2020
- First submitted
- 8 Sep 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21319149Eisenhauer 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.
PubMed 19097774
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of TAS 102 in Recurrent/Metastatic Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT04627961
- Acronym / sponsor ID
- NP01/05/19
- Keywords
- TAS102, NPC
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- 26 Aug 2020 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- To determine the clinical efficacy of TAS-102 in recurrent and metastatic NPC
- To assess the safety and tolerability of TAS-102 in the study population of R/M NPC
- To study the pharmacokinetics of TAS-102 in the study population of R/M NPC
- To study potential predictive biomarkers for clinical benefit from TAS-102
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Eligible patients who consent to participate will receive oral TAS-102 for days 1-5 and 8-12 of a 28 day cycle.
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Drug: TAS-102Patients with EBER positive nasopharyngeal carcinoma with recurrent or metastatic disease |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TAS-102Also: LONSURFEligible patients who consent to participate will receive oral TAS-102 bid for days 1-5 and 8-12 of a 28 day cycle. | Drug | Patient |
Primary outcome
Disease control rate
Time frame: 45 months
As defined by complete response (CR) + partial response (PR) + stable disease (SD) at 12 weeks of assessment using RECIST 1.1.
2 secondary outcomes
Progression free survival rate of patients
Time frame: 45 months
Best objective response rate
Time frame: 45 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
- Results publication: PubMed 21319149An 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.
- Results publication: PubMed 19097774Eisenhauer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boon Cher Goh principal investigator
National University Hospital, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing TAS-102 in people with Metastatic Nasopharyngeal Carcinoma and Recurrent Nasopharyngeal Carcinoma, run by National University Hospital, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boon Cher Goh (6779 5555, phcgbc@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease control rate (time frame: 45 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04627961, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2020.