Nasopharyngeal Carcinoma (NPC)Phase 1NCT06611150
Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
A Phase 1 study testing Nab-paclitaxel in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to determine the maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy in nasopharyngeal carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma (NPC)
- What is being tested?
- Nab-paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2024to 1 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pathologically confirmed nasopharyngeal carcinoma
- III-IVa (AJCC8th)
- age 18-70
- PS score 0-1
- normal functions to tolerate chemotherapy and radiotherapy
Who cannot join
- The presence of other malignant neoplasms within the preceding five years, with the exception of carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer, is permitted.
- Symptomatic heart failure, unstable angina, myocardial infarction, active infections requiring systemic therapy, psychiatric disorders, or family and social factors
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pu-Yun OuYang contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Fang-Yun Xie, +8613902205880, xiefy@sysucc.org.cn
Pu-Yun OuYang, ouyangpy@sysucc.org.cn
About this study
Official title: A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
The goal of this clinical trial is to determine the maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy in nasopharyngeal carcinoma. Researchers will observe the toxicity response of patients receiving nab-paclitaxel at 180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m².
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Being tested
- Nab-paclitaxel
- Keywords
- nasopharyngeal carcinoma, nab-paclitaxel, concurrent chemotherapy
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab-paclitaxelDrug
All participants enrolled in the study will be treated with nab-paclitaxel during radical radiotherapy following induction chemotherapy. The doses are increased progressively (180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m²).
| Study group | Role | What they receive |
|---|---|---|
| nab-paclitaxel arm | Experimental | All patients enrolled in the study will be treated with nab-paclitaxel during radical radiotherapy following induction chemotherapy. The doses are increased progressively from 180 mg/m² to a maximum of 260 mg/m². Receives: Drug: Nab-paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum tolerated dose and the recommended phase II dose
The maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy.
Measured: From start of radiotherapy to 2 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start2 Aug 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal Carcinoma (NPC)Studies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fang-Yun Xie, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611150
- Sponsor's protocol ID
- B2024-076-01
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Concurrent Nab-paclitaxel with Intensity-modulated Radiation Therapy in Patients with Stage III-IVa Nasopharyngeal Carcinoma
- ClinicalTrials.gov ID
- NCT06611150
- Acronym / sponsor ID
- B2024-076-01
- Conditions
- Nasopharyngeal Carcinoma (NPC)
- Keywords
- nasopharyngeal carcinoma, nab-paclitaxel, concurrent chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 2 Aug 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2027 (estimated)
- First posted
- 24 Sep 2024 (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.
The goal of this clinical trial is to determine the maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy in nasopharyngeal carcinoma. Researchers will observe the toxicity response of patients receiving nab-paclitaxel at 180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m².
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| nab-paclitaxel arm | Experimental | Drug: Nab-paclitaxelAll patients enrolled in the study will be treated with nab-paclitaxel during radical radiotherapy following induction chemotherapy. The doses are increased progressively from 180 mg/m² to a maximum of 260 mg/m². |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pathologically confirmed nasopharyngeal carcinoma
- III-IVa (AJCC8th)
- age 18-70
- PS score 0-1
- normal functions to tolerate chemotherapy and radiotherapy
Key exclusion criteria (2 listed)
- The presence of other malignant neoplasms within the preceding five years, with the exception of carcinoma in situ, adequately treated non-melanoma skin cancer and papillary thyroid cancer, is permitted.
- Symptomatic heart failure, unstable angina, myocardial infarction, active infections requiring systemic therapy, psychiatric disorders, or family and social factors
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 |
|---|---|---|
| Nab-paclitaxelAll participants enrolled in the study will be treated with nab-paclitaxel during radical radiotherapy following induction chemotherapy. The doses are increased progressively (180 mg/m², 200 mg/m², 230 mg/m², and 260 mg/m²). | Drug | nab-paclitaxel arm |
Primary outcome
The maximum tolerated dose and the recommended phase II dose
Time frame: From start of radiotherapy to 2 weeks after completion of radiotherapy
The maximum tolerated dose and the recommended phase II dose for nab-paclitaxel when administered concurrently with radiotherapy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- 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.
Pu-Yun OuYang contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nab-paclitaxel in people with Nasopharyngeal Carcinoma (NPC), run by Sun Yat-sen University at 1 site in China.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 27 Sep 2024. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fang-Yun Xie (+8613902205880, xiefy@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum tolerated dose and the recommended phase II dose (time frame: From start of radiotherapy to 2 weeks after completion of radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Sep 2024.