Adenoid Cystic CarcinomasPhase 2NCT03639168
Chidamide Combined With Cisplatin in Head and Neck Adenoid Cystic Carcinoma (HNACC)
A Phase 2 study testing Chidamide combined with cisplatin in people with Adenoid Cystic Carcinomas and Cisplatin, run by Fudan University at 1 site in China.
Trial summary
The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Adenoid Cystic Carcinomas, Cisplatin
- What is being tested?
- Chidamide combined with cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteChina
- Study dates
- 6 Jun 2018to 2 Jun 2021
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range 18-75 years old
- Histological confirmed recurrent or metastatic head and neck adenoid cystic carcinoma
- Unable to treat with surgery/radiotherapy, or previously failure to non-cisplatin systematic treatment;
- Eastern Cooperative Oncology Group performance status 0 to 2;
- Patients have written informed consent to participate in the study;
- anticipated to live ≧3 months;
Show all 11Show fewer
- Absolute neutrophil count ≥ 1.5×109/L，platelet ≥ 100×109/L，hemoglobin ≥ 90 g/L
- total bilirubin < 1.5×upper limit of normal(ULN), ALT and AST < 3× ULN
- serum creatine <1.5×ULN, and creatinine clearance rate (CCR) ≥ 50 ml/min
- Ultrasonic cardiogram showed left ventricle ejection fraction ≥ 50%, EKG showed no signs of myocardial ischemia, with no previous arrhythmia which need pharmacological intervention.
- Measurable disease was defined as at least one lesion ≥1.5 cm in length-diameter and ≥0.5 cm in short-diameter by CT.
Who cannot join
- Previously treated with HDACi;
- Treated with cisplatin-contained regimes in the past half of the year, and not achieving PR/CR;
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
- HIV, HCV, or syphilis infection；
- Pregnant or lactating women;
- Serious uncontrolled infection;
Show all 11Show fewer
- Severe neurol of mental illness, including dementia and epilepsy;
- Having contraindications to the use of oral medication, such as unable to swallow, nausea and vomiting, chronic diarrhea or suffering from a bowel obstruction;
- Participated in other clinical trials in 4 weeks;
- Other coexisting diseases or situations that may cause patients to fail to complete clinical trials;
- History of QTc interval prolongation (Male >450ms，Female >470ms), ventricular tachycardia, auricular fibrillation, heart block of more than II degrees, myocardial infarction in 1 year, congenital heart disease, with symptomatic coronary heart disease requiring medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Chidamide Combined With Cisplatin in Recurrent or Metastatic Head and Neck Adenoid Cystic Carcinoma: A Prospective, Open-label, Phase II Study of a Single Center
The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.
Read the detailed description
Adenoid cystic carcinomas (ACCs) constitute of 1% of head and neck cancers. This type of tumor grows slowly with a high potential of local recurrence. Approximately 50% of patients develop distant metastases, and 33% patients die within 2 years. The initial therapy of these malignancies consists of surgical resection followed by radiotherapy. Systemic therapy is crucial in the management of recurrent and metastatic disease. However, nowadays, there were no standard chemoimmunotherapy regimes. Previous report showed that overall response rate was only less than 10% using single-agent chemotherapies, and the best results were achieved by cisplatin. Chidamide is a new benzamide class of histone deacetylase inhibitor with marked antitumor activity. And a phase I study has showed that one of three patients with submandibular adenoid cystic carcinoma achieved a partial response treated with Chidamide. The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma, in order to find a potential promising way to treat this kind of disease.
- Conditions
- Adenoid Cystic Carcinomas, Cisplatin
- Being tested
- Chidamide combined with cisplatin
- Medical subject headings
- Carcinoma, Adenoid Cystic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chidamide combined with cisplatinDrug
Chidamide combined with cisplatin
| Study group | Role | What they receive |
|---|---|---|
| Chidamide combined with Cisplatin | Experimental | Chidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 25mg/m2 ivgtt D1-3 Chidamide :20mg PO Biw, 2 week on , 1 week off Receives: Drug: Chidamide combined with cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate (ORR)
Defined as numbers of patients achieved complete response and patial response of treatment
Measured: 6 weeks
Secondary outcomes (3)
Disease control rate (DCR)
Defined as numbers of patients achieved complete response, patial response, and stable disease of treatment
Measured: 6 weeks
Progression-free survival (PFS)
Defined as the time from randomization until objective tumor progression or death
Measured: 6 weeks
Scoring of quality of life: EORTC-QLQ-30
Quality of life was evaluated using EORTC-QLQ-30. All subscales are summed to compute a total score, and total scores are recorded. Lower scores represent a better outcome.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study start6 Jun 2018
- Primary completion24 Jun 2020
- Study completion2 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adenoid Cystic CarcinomasStudies of the same condition, open and under way.
- More trials run by Fudan 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Xue, MD, Fudan University
- Investigators
- Kai Xue, MD, Principal investigator, Department of medical oncology,Fudan University, Shanghai Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639168
- Sponsor's protocol ID
- CC-HN-1
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2018
- Last updated
- 19 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chidamide Combined With Cisplatin in Recurrent or Metastatic Head and Neck Adenoid Cystic Carcinoma: A Prospective, Open-label, Phase II Study of a Single Center
- ClinicalTrials.gov ID
- NCT03639168
- Acronym / sponsor ID
- CC-HN-1
- Conditions
- Adenoid Cystic Carcinomas, Cisplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 6 Jun 2018 (actual)
- Primary completion
- 24 Jun 2020 (actual)
- Study completion
- 2 Jun 2021 (actual)
- First posted
- 21 Aug 2018 (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 investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma.
Detailed description
Adenoid cystic carcinomas (ACCs) constitute of 1% of head and neck cancers. This type of tumor grows slowly with a high potential of local recurrence. Approximately 50% of patients develop distant metastases, and 33% patients die within 2 years. The initial therapy of these malignancies consists of surgical resection followed by radiotherapy. Systemic therapy is crucial in the management of recurrent and metastatic disease. However, nowadays, there were no standard chemoimmunotherapy regimes. Previous report showed that overall response rate was only less than 10% using single-agent chemotherapies, and the best results were achieved by cisplatin. Chidamide is a new benzamide class of histone deacetylase inhibitor with marked antitumor activity. And a phase I study has showed that one of three patients with submandibular adenoid cystic carcinoma achieved a partial response treated with Chidamide. The investigators conducted this study to evaluate the efficacy of Chidamide combined with cisplatin in recurrent or metastatic head and neck adenoid cystic carcinoma, in order to find a potential promising way to treat this kind of disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chidamide combined with Cisplatin | Experimental | Drug: Chidamide combined with cisplatinChidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 25mg/m2 ivgtt D1-3 Chidamide :20mg PO Biw, 2 week on , 1 week off |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age range 18-75 years old
- Histological confirmed recurrent or metastatic head and neck adenoid cystic carcinoma
- Unable to treat with surgery/radiotherapy, or previously failure to non-cisplatin systematic treatment;
- Eastern Cooperative Oncology Group performance status 0 to 2;
- Patients have written informed consent to participate in the study;
Key exclusion criteria (11 listed)
- Previously treated with HDACi;
- Treated with cisplatin-contained regimes in the past half of the year, and not achieving PR/CR;
- History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
- HIV, HCV, or syphilis infection；
- Pregnant or lactating women;
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 |
|---|---|---|
| Chidamide combined with cisplatinChidamide combined with cisplatin | Drug | Chidamide combined with Cisplatin |
Primary outcome
Overall response rate (ORR)
Time frame: 6 weeks
Defined as numbers of patients achieved complete response and patial response of treatment
3 secondary outcomes
Disease control rate (DCR)
Time frame: 6 weeks
Progression-free survival (PFS)
Time frame: 6 weeks
Scoring of quality of life: EORTC-QLQ-30
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2021.
Related trials for Adenoid Cystic Carcinomas
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1/2
VMD-928 Monotherapy and in Combination With Pembrolizumab to Treat TrkA Overexpression Driven Solid Tumors or Lymphoma
Head and Neck Carcinoma, Adenoid Cystic Carcinoma
RecruitingObservational study
SPARE-1st: Surgery Alone vs Surgery Plus Postoperative Radiotherapy for Sinonasal Adenoid Cystic Carcinoma
Adenoid Cystic Carcinoma, Sinonasal Carcinoma
RecruitingPhase 2
Neoadjuvant Anlotinib and Epirubicin for T4 Sinonasal Adenoid Cystic Carcinoma
Adenoid Cystic Carcinoma
RecruitingObservational study
Surgery Plus Postoperative Radiotherapy for T4 Sinonasal Adenoid Cystic Carcinoma
Adenoid Cystic Carcinoma, Sinonasal Carcinoma
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.
Kai Xue, MD principal investigator
Department of medical oncology,Fudan University, Shanghai Cancer Center
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 Chidamide combined with cisplatin in people with Adenoid Cystic Carcinomas and Cisplatin, run by Fudan 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 11 inclusion and 11 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: finished, as of the sponsor's last update on 19 Aug 2021. 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (ORR) (time frame: 6 weeks). 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 19 Aug 2021.