NCT02496949

Brief Summary

to assess the safety, tolerability，PK and efficacy profile of two doses (600mg,800mg,BID) of Icaritin in advanced solid tumor patients in China

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Nov 2011

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

November 1, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 5, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2015

Completed
Last Updated

July 14, 2015

Status Verified

July 1, 2015

Enrollment Period

1.5 years

First QC Date

July 5, 2015

Last Update Submit

July 13, 2015

Conditions

Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • The number of patients reported adverse events

    1-2 year

Secondary Outcomes (3)

  • Progression free survival

    1-2 Years

  • Time to tumor progression

    1-2 Years

  • Overall survival

    1-2 Years

Study Arms (1)

Icaritin

EXPERIMENTAL

600mg,800mg two doses, Bid, continuous dosing for 56 days, to assess the safety,tolerance,pharmacokinetics and efficacy of icaritin

Drug: Icaritin

Interventions

IcaritinDRUG

600mg,800mg two doses, Bid, continuous dosing for 56 days, to assess the safety,tolerance,pharmacokinetics and efficacy of icaritin

Also known as: IC-162
Icaritin

Eligibility Criteria

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

You may qualify if:

  • age≥18 years old and ≤65
  • The patients with advanced breast tumors，hepatocellular carcinoma (HCC) or other advanced solid tumor patients who are confirmed through histologic or cytologic diagnosis to be ER positive or subjects whom investigators believe may benefit from the trial.
  • Patients with advanced cancer that relapsed after or failed previous standard treatment
  • ≤BMI index≤30
  • No serious heart, liver,lung and kidney diseases.
  • Received at least one anti-cancer treatment (including chemotherapy, radiotherapy, biological or endocrine treatment). And the last treatment must be at least four weeks before study enrollment or after 5 times of the drug's half-life time has passed. The surgery treatment must be more than three months.
  • Life expectancy of at least 12 weeks. 8 .Patients who can cooperate to observe AE and efficacy.
  • \. No any other concurrent anti-cancer treatment 10. A signed informed consent must be obtained prior to performing any study specific procedures.
  • \. The Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 12. Female:Women with childbearing potential must have a negative pregnancy test performed 13. HCC patients: Child-Pugh Class of A or B

You may not qualify if:

  • Have a known hypersensitivity to flavonoid drugs.
  • Hepatic:
  • HCC patients : ALB \<2.8g/dL, TB\>3.0mg/dL, ALT and AST \> 2.5 times the upper limit of Normal
  • Advanced breast tumors or other advanced solid tumor patients: ALB \>limit of normal, TB\> the upper limit of normal, ALT and AST \> upper limit of Normal Renal: Serum Creatinine \>1.5 times the upper limit of normal. Blood test: Absolute neutrophil count (ANC) \< 1.5 × 109/L, Platelet count \< 90 × 109/L, Hemoglobin \<9 g/dL.
  • PT/APTT \>1.25 times the upper limit of normal. HCC patients: PT \> 5 seconds above control
  • Suffered from thrombotic disease.
  • Serum Ca \> the upper limit of normal.
  • Not recovered from toxic effects of previous anti-cancer treatments or surgery.
  • Any serious or uncontrollable concomitant systemic disorder (such as unstable respiratory disorders, cardiovascular, hepatic or kidney disorders.) or active infection which will influence the clinical trial.
  • CNS metastases or invade requiring treatment for unstable status or various psychiatric disorders
  • Malabsorption or other disease which will affect the drug absorption,distribution,metabolism and excretion.
  • Other concurrent malignancies with the exception of cervical cancer in situ or squamous cell carcinoma of the skin .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cancer institute & hospital, chinese academy of medical sciences

Beijing, Beijing Municipality, 100021, China

Location

Related Publications (1)

  • Fan Y, Li S, Ding X, Yue J, Jiang J, Zhao H, Hao R, Qiu W, Liu K, Li Y, Wang S, Zheng L, Ye B, Meng K, Xu B. First-in-class immune-modulating small molecule Icaritin in advanced hepatocellular carcinoma: preliminary results of safety, durable survival and immune biomarkers. BMC Cancer. 2019 Mar 28;19(1):279. doi: 10.1186/s12885-019-5471-1.

    PMID: 30922248DERIVED

MeSH Terms

Interventions

icaritin

Study Officials

  • Bing he Xu, MD

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Internal medicine director,Cancer institute & hospital

Study Record Dates

First Submitted

July 5, 2015

First Posted

July 14, 2015

Study Start

November 1, 2011

Primary Completion

May 1, 2013

Study Completion

August 1, 2013

Last Updated

July 14, 2015

Record last verified: 2015-07

Locations

CN(1)