A Phase I Study of Epitinib(HMPL-813) in Patients With Ad... | NCT02590952

NCT02590952

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Status Module

Arms/Interventions Module

Label	Type	Description	Intervention Names
Epitinib	Experimental	Epitinib is a capsule in the form of 5mg,20 mg, and 40 mg. Route: oral (daily)	Drug: Epitinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epitinib	Drug	The starting daily dose is 20 mg. Dose escalation will follow daily dose of 40 mg,80 mg, 120 mg, 160 mg, 200 mg, and 250 mg. A 3+3 design applies to this study. Patients will continue taking Epitinib until they experience intolerable adverse events or their diseases are confirmed to be progressed.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
incidence of all types/grades of adverse events	for each patient, adverse events are collected from the date of consent until 30 days after trial discontinuation	from first patient in till 30 days after the last patient last visit. It is estimated that last patient last visit happens in Oct 2016.

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate		An average of one year
Area under the plasma concentration versus time curve (AUC)	Based on single-dose PK result, multi-dose stage subjects take epitinib either once a day or twice a day. For twice a day epitinib uptake, on day 1/14/28, PK samples are collected predose, 1, 4, 8, 12 hours post-dose in the morning and 4 hours post-dose in the evening. On day 2/3/7, PK samples are collected predose, 4, 12 hours post-dose in the morning and 4 hours post-dose in the evening. On day 15/29/56, PK samples are collected predose in the morning. For once a day epitinib uptake, on day 1/14/28 PK samples are collected predose, 0.5, 1, 2, 4, 6, 8, 12 hours post-dose. On day 7, PK samples are collected predose and 4 hours post-dose. On day 2/15/29/56, PK samples are collected predose in the morning.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histopathology confirmed solid tumors
Failed to standard treatment or no standard treatments for uncontrolled, recurrent and/or metastatic advance tumor (whatever previous surgery conditions)
Age 18-70
ECOG 0-2, and no worse within 7days
Life expected > 12 weeks
written informed consent form voluntarily
For dose expansion cohort, subjects must be eligible for the following inclusion criteria:
EGFR sensitizing mutation in exon 19 deletion or exon 21(L858R).
Histologically or cytologically confirmed advanced NSCLC with brain metastasis. No prior brain radiotherapy or brain metastasis progressed after brain radiotherapy delivered assessed by RECIST 1.1.
No prior EGFR-TKI treatment. Or subjects who treated with EGFR-TKI developed brain lesions during EGFR-TKI therapy or the existing brain lesions progressed but with stable extra-cranial lesions.
Treatment failure of prior systemic chemotherapy for locally advanced or metastasized NSCLC or intolerance to chemotherapy. Or subjects with disease relapse after treated with adjuvant or neo-adjuvant chemotherapy.
With at least one measurable disease ( RECIST 1.1).

Exclusion Criteria:

Lab testing within 2 weeks before enrolled, AND ANC<1.5×10 9/L, platelet<75×10 9/L, or Hb<9g/dL,
Serum Total Bilirubins > ULN, ALT/AST≥ULN without liver metastasis, or ALT/AST≥2.5ULN with liver metastasis
Serum creatinine >1.5ULN or creatinine clearance <40ml/min
Diastolic systolic pressure≥140mmHg or systolic diastolic pressure≥90mmHg whatever anti-hypertension drug used,
Serum potassium <4.0mmol/L(whenever potassium implemented), serum calcium(ionic or albumin-type calcium) or serum magnesium outside normal ranges(whenever implemented)
Within previous 4 weeks treated by systemic anti-tumor therapy, or radiotherapy, immune therapy, biological or hormonal therapy, and clinical trials.
Unrecovered from any previous therapy related toxicity to CTCAE 0 or 1or unrecovered from any previous surgery
Known dysphagia or drug malabsorption
Active infections such as acute pneumonia, hepatitis B immune-active periodphase
ocular surface diseases or dry eye syndrome
skin disease with obvious symptoms and signs
significant cardiovascular disease, including II-IV atrioventricular block, and acute myocardial infarction within 6 months, significant angina or Coronary artery bypass graft within 6 months
Female patients who are pregnant or feeding, or childbearing potential patient with pregnant testing positive
Any abnormal of clinical and laboratory so that patients unsuitable to attend the trial sine in the opinion of the investigator
Patients unable to comply with the protocol since significant psychological or psychogenic abnormal