A Study of DBPR112 in Patients With Head and Neck Cancer and EGFR Mutated Lung Cancer

NCT03246854 | Terminated Phase 1 FDA Drug

• 1 other identifier: DBPR112-101
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

The study is being performed to assess the MTD, pharmacokinetics (PK), safety, tolerability and preliminary antitumor activity of DBPR112 in patients with head and neck cancer and EGFR mutated lung cancer.

Conditions

Head and Neck Cancer; NSCLC

Keywords

DBPR112; EGFR mutated NSCLC; squamous cell cancer of head and neck; maximum tolerated dose; recommended Phase 2 dose

Outcome Measures

Primary Outcomes (4)

• Maximum Tolerated Dose (MTD)

  up to 22 months

• Area Under the Plasma Concentration-Time Curve (AUC from 0 to infinity)

  For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.

• Observed Maximum Plasma Concentration (Cmax)

  For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.

• Time of Maximum Plasma Concentration (tmax)

  For Cycle 1 (each cycle is 28 days) and Cycle 2, Day 1, predose (0 hr), 0.5, 1, 2, 3, 4, 6, 8 and 24 hrs (i.e. predose on Day 2).Predose samples on Cycle 1 Days 8, 15, 22, and 28, Cycle 2 Day 15, and Cycle3-6 Days 1 and 15.

Secondary Outcomes (2)

• Incidence and intensity of Adverse Events and Serious Adverse Events as a measure of safety

  Adverse events were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.

• Preliminary antitumor activity of DBPR112 in patients with solid tumors

  The tumor responses were collected from the time of the first dose of investigational product until 30 days after the last dose of investigational product administration.

Study Arms (1)

DBPR112

EXPERIMENTAL

Drug: DBPR112

Interventions

DBPR112 DRUG

DBPR112 hard gelatin capsule solid dosage formulation; strength: 25 mg, 100 mg.

DBPR112

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients
• Age from ≥18 to ≤70 years
• Life expectancy \>12 weeks per investigator's judgement
• Squamous cell carcinoma of head and neck that has failed prior standard therapy for metastatic disease or advanced EGFR-mutated NSCLC that has failed prior standard therapy including at least one anti EGFR TK inhibitor
• Non-measurable but evaluable disease, or measurable disease per RECIST 1.1
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Adequate blood and organ function
• Male and female patients must agree to use contraception while on study and for 90 days after the last dose of DBPR112
• Aspartate aminotransferase/ALT \<3 X ULN if no metastasis, and AST/ALT \<5 X ULN in presence of metastasis

You may not qualify if:

• History of allergic reactions to any component of DBPR112
• History of unstable central nervous system (CNS) metastases or seizure disorder related to the malignancy; however, those patients who were treated for prior CNS metastases and who are asymptomatic may participate in the study
• History of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, or cardiac arrhythmia
• Exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 28 days for chemotherapeutics and targeted agents, or 5 half-lives for proteins, whichever is longer, before the first dose of DBPR112
• Significant surgical intervention within 21 days of the first dose of DBPR112 or with ongoing postoperative complications
• Chronic skin condition that requires prescribed oral or intravenous treatment
• History of severe rash that required discontinuation of prior EGFR targeted therapy
• History of interstitial lung disease or non-infectious pneumonitis except for those induced by radiation therapy
• Toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 or equivalent
• Insufficient organ function as indicated by the following parameters
• Absolute neutrophil count (ANC) \<1,500 /µL
• Platelets \<100,000 /µL
• Hemoglobin \<10 g/dL
• Serum creatinine \>1.5 X ULN
• Serum total bilirubin \>1.5 X ULN

Sponsors & Collaborators

• National Health Research Institutes, Taiwan: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Taipei Medical University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

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

Study Record Dates

• First Submitted: July 7, 2017
• First Posted: August 11, 2017
• Study Start: July 18, 2017
• Primary Completion: August 4, 2018
• Study Completion: August 4, 2018
• Last Updated: December 17, 2020

Record last verified: 2019-10

Locations

TW (2)