NCT03639168

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2018

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

August 21, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 24, 2020

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2021

Completed
Last Updated

August 19, 2021

Status Verified

August 1, 2021

Enrollment Period

2.1 years

First QC Date

August 4, 2018

Last Update Submit

August 18, 2021

Conditions

Adenoid Cystic CarcinomasCisplatin

Outcome Measures

Primary Outcomes (1)

  • Overall response rate (ORR)

    Defined as numbers of patients achieved complete response and patial response of treatment

    6 weeks

Secondary Outcomes (3)

  • Disease control rate (DCR)

    6 weeks

  • Progression-free survival (PFS)

    6 weeks

  • Scoring of quality of life: EORTC-QLQ-30

    6 weeks

Other Outcomes (1)

  • Serum ctDNA biomarker

    throughout the treatment period，up to 6 months

Study Arms (1)

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

Drug: Chidamide combined with cisplatin

Interventions

Chidamide combined with cisplatinDRUG

Chidamide combined with cisplatin

Chidamide combined with Cisplatin

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • 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.

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kai Xue

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

Cisplatin

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Chlorine CompoundsInorganic ChemicalsNitrogen CompoundsPlatinum Compounds

Study Officials

  • Kai Xue, MD

    Department of medical oncology,Fudan University, Shanghai Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 4, 2018

First Posted

August 21, 2018

Study Start

June 6, 2018

Primary Completion

June 24, 2020

Study Completion

June 2, 2021

Last Updated

August 19, 2021

Record last verified: 2021-08

Locations

CN(1)