Phase I/II Trial to Evaluate Safety, Tolerability and Pharmacokinetic Profile of HM61713 in NSCLC Patients

NCT01588145 | Completed Phase 1

• 1 other identifier: HM-EMSI-101
• Study Type: interventional
• Target: 273
• Locations: 1 country
• Sites: 1

Brief Summary

The main objective of this study is to evaluate the safety and tolerability of HM61713.

Conditions

Non Small Cell Lung Cancer

Keywords

NSCLC; HM61713; EGFR-TKI; Phase II; olmutinib

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  Dose limiting Toxicity will be evaluated on Day 24 during Cycle 1

Study Arms (1)

HM61713

EXPERIMENTAL

Drug: HM61713

Interventions

HM61713 DRUG

BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops

Also known as: Olmutinib

HM61713

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with histologically or cytologically confirmed diagnosis of advanced NSCLC
• Patients with EGFR mutation-positive tumor
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or less
• Estimated life expectancy of at least 12 weeks
• Subjects with adequate bone marrow (WBC ≥4,000/mm3, Platelet ≥100,000/mm3, Hemoglobin≥9.0g/dL, ANC≥1,500/mm3), renal (Creatinine≤1.5 mg/dl) and hepatic \[aspartate aminotransferase (AST)/ alanine aminotransferase (ALT)/ alkaline phosphatase (ALP)≤3 x ULN, Total bilirubin ≤2.0 mg/dL\] function. No significant heart and lung disease.
• ※ For subjects with a liver metastases, AST/ALT/ALP≤ 5 x ULN is allowed; and for subjects with bone marrow metastases, ALP≤ 5 x ULN is allowed
• Patients with amylase level ≤ 1.5 x ULN
• Subjects who have provided voluntary consent to participate in the study, and signed the written consent document
• \<Dose escalation part\>
• \- Malignancy that has progressed after at least two prior chemotherapy regimens, including EGFR-TKI
• \<Expansion part 1\>
• Patients with disease progression despite anticancer therapy with EGFR-TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib)
• Patients who have provided voluntary consent for collection of tumor tissue taken and archived after the last anticancer therapy or collection of new tissue specimen and signed the written consent document
• \<Expansion part 2\> \& \<Phase 2\>
• Patients with disease progression despite anticancer therapy with EGFR TKI (e.g., erlotinib, gefitinib, neratinib, afatinib, dacomitinib) (Except treatment with EGFR mutation selective inhibitor, the same class of drug as investigational drug in this study)

You may not qualify if:

• Hematologic malignancies
• Symptomatic or uncontrolled central nervous system metastases
• Interstitial lung disease, including pulmonary fibrosis
• LVEF \< 40% or NYHA Class III or IV heart failure
• History of pancreatitis
• History or current evidence, of any psychiatric or congenital disorder, including dementia or epilepsy
• Compromised organ function, infection or allergy
• Pregnant or breast-feeding women, or women of child-bearing potential who do not use an appropriate method of contraception (male patients should also use an appropriate method of contraception during the study period)
• Patients who had received other investigational product within 30 days prior to screening

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

olmutinib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dong-Wan Kim, MD PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: April 30, 2012
• Study Start: March 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 24, 2018

Record last verified: 2018-04

Locations

KR (1)