Know Cancer

forgot password

A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies

Phase 1
18 Years
70 Years
Not Enrolling
Advanced Solid Cancer

Thank you

Trial Information

A Phase I Study of Henatinib in Patients With Advanced Solid Malignancies

1. To evaluate the safety and tolerability of Henatinib, and the maximum tolerated dose
(MTD) and dose-limiting toxicity (DLT).

2. To determine the pharmacokinetic profile of Henatinib and its metabolites .

3. To assess preliminary antitumor activity .

4. To determine preliminary regimen for phase II study .

Inclusion Criteria:

1. Histologically or cytologic (except sputum smear) confirmed metastatic or locally
advanced solid tumor (At least one measurable lesion longest diameter ≥20 mm using
conventional techniques or larger than 10 mm in diameter by spiral CT scan).

2. Life expectancy of more than 12 weeks.

3. Lack of standard treatment or standard treatment failure.

4. Screening laboratory values within the following parameters:

1. HB:≥90g/L

2. ANC:≥1.5×109/L

3. PLT:≥100×109/L

5. ALT and AST:≤1.5×ULN(But if the liver metastases, ALT and AST:≤5×ULN) 1. Serum total
bilirubin:≤1.5×ULN 2. Serum creatinine:≤1.5×ULN 3. Creatinie clearance rate:≥60ml/min
4. Electrolytes normal or return to normal after treatment

6. Recovery from all clinically significant AEs related to prior therapies. Duration
from the latest therapy is more than 6 weeks for nitroso or mitomycin, or more than 4
weeks for radiotherapy, chemotherapy, immunotherapy or other anti-cancer treatments
(such as testing drugs, biologics, hormones or surgery).

7. Signed and dated informed consent. Willingness and ability to comply with scheduled
visits, treatment plans, laboratory tests, and other study procedure.

Exclusion Criteria:

1. Evidence of CNS metastasis.

2. Major surgery, open biopsy, or obvious trauma within 4 weeks before treatment.

3. Obvious peritoneal implantation or pelvic obstruction.

4. II level or above, peripheral neuropathy (NCI CTC AE v3.0).

5. Known history of neurological or psychiatric disease.

6. Suffering from high blood pressure and can not be reduced to the following range by
monotherapy (systolic blood pressure <140 mmHg, diastolic blood pressure <90 mmHg).

7. History of heart disease:> NYHA II class congestive heart failure; unstable coronary
artery disease (patients who had last myocardial infarction 12 months before can be
enrolled), arrhythmias - requires antiarrhythmic drug therapy. Bazett's corrected QTc
≥ 480 ms or can not be measured. (Note: If ECG QTc interval ≥ 480 ms during the
screening period, you must repeat 2 times, separated by at least 24 hours, the
average QTc of the 3 times must be <480 s, the patient can be enrolled in this study)

8. Coagulopathy (PT> 16 s, APTT> 43 s, TT> 21 s, Fbg <2 g / L), with a bleeding tendency
or are receiving the therapy of thrombolysis or anticoagulation.

9. Confirmed active gastrointestinal ulcers.

10. Active severe infection (> NCI-CTC 3.0 standard 2).

11. Patients with severe epilepsy requires drug treatment (such as steroids or
anti-epileptic drugs).

12. Other serious illness or condition.

13. Treated with VEGFR TKIs such as sunitinib or solafenib before study entry.

14. Less than 4 weeks from the last clinical trial.

15. Pregnancy, breast-feeding women or women of childbearing age without effective

16. Allergic or known history of hypersensitivity to henatinib or any of it components.

17. Drug abuse, the drug and mental illness may affect the patients participation in this
study and the assessment of the research results.

18. Any unstable or likely situation that harms the safety and compliance of the patients
in this study.

19. Any factors that influence the usage of oral administration.

20. Evidence of significant medical illness that in the investigator's judgment will
substantially increase the risk associated with the subject's participation in and
completion of the study.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The maximum-tolerated dose (MTD) regimen of henatinib will be defined as the maximum dose level at which no more than one subject out of six experiences a dose-limiting toxicity (DLT) after completing one treatment cycle.

Outcome Time Frame:

4 weeks

Safety Issue:


Principal Investigator

jin Li, Dr

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fudan University


China: Food and Drug Administration

Study ID:




Start Date:

September 2010

Completion Date:

December 2012

Related Keywords:

  • Advanced Solid Cancer
  • Advanced solid cancer
  • Henatinib
  • phase I