Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

D-0316 First Time in Patients Ascending Dose Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03452150
Recruitment Status : Active, not recruiting
First Posted : March 2, 2018
Last Update Posted : June 18, 2021
Sponsor:
Information provided by (Responsible Party):
InventisBio Inc.

Brief Summary:
This is a phase 1 open label multicentre study of D-0316 administered orally in patients with advanced NSCLC who have progressed following prior therapy with an EGFR-TKI (Epidermal Growth Factor Receptor tyrosine kinase inhibitor agent). This is the first time this drug has ever been tested in patients, and so it will help to understand safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of D-0316.

Condition or disease Intervention/treatment Phase
Advanced Non Small Cell Lung Cancer Drug: D-0316 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of D-0316 in Patients With Advanced Non Small Cell Lung Cancer With Mutation of Epidermal Growth Factor Receptor Tyrosine Kinase
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : August 28, 2020
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Daily oral dose of D-0316 Drug: D-0316
If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 - Day 28 ]
    Incidence of DLTs

  2. Adverse events [ Time Frame: Day 1 - Day 28 ]
    Incidence of AEs

  3. Laboratory results [ Time Frame: Day 1 - Day 28 ]
    Incidence of laboratory abnormalities

  4. Vital signs [ Time Frame: Day 1 - Day 28 ]
    Incidence of vital sign abnormalities

  5. Electrocardiogram [ Time Frame: Day 1 - Day 28 ]
    Incidence of ECG abnormalities


Secondary Outcome Measures :
  1. Pharmacokinetic: area under the plasma concentration versus time curve (AUC) [ Time Frame: Day 1 through 6, Cycle Day 1-Day 15 ]
    AUC: area under the plasma concentration versus time curve for D-0316

  2. Pharmacokinetic: maximum plasma drug concentration (Cmax) [ Time Frame: Day 1 through 6, Cycle Day 1-Day 15 ]
    Cmax: maximum plasma drug concentration of D-0316

  3. Pharmacokinetic: Time to reach the Cmax (Tmax) [ Time Frame: Day 1 through 6, Cycle Day 1-Day 15 ]
    tmax: Time to reach the Cmax of D-0316

  4. Pharmacokinetic: Apparent terminal half-life (t1/2) [ Time Frame: Day 1 through 6, Cycle Day 1-Day 15 ]
    t1/2: apparent terminal half-life of D-0316

  5. Antitumor activity [ Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]
    Antitumor activity by evaluation of tumor response assessments using Response Evaluation Criteria in Solid Tumours (RECIST 1.1)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provision of signed and dated, written informed consent prior to any study specific procedures, sampling and analyses
  • Histological or cytological confirmation diagnosis of Non Small Cell Lung Cancer (NSCLC).
  • Radiological documentation of disease progression while on a previous continuous treatment with an EGFR TKI e.g. gefitinib or erlotinib. In addition other lines of therapy may have been given. All patients must have documented radiological progression on the last treatment administered prior to enrolling in the study.
  • Confirmation that the tumour harbours an EGFR T790M mutation.
  • No deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks.
  • Evaluable or measurable disease per RECIST v1.1

Exclusion Criteria:

  • Treatment with an EGFR TKI (erlotinib or gefitinib) within 14 days of the first dose of study treatment.
  • Any cytotoxic chemotherapy, investigational agents or other anticancer drugs from the treatment of advanced NSCLC from a previous treatment regimen or clinical study within 14 days of the first dose of study treatment.

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452150


Locations
Layout table for location information
China, Jilin
Research Site
Changchun, Jilin, China, 130012
China, Shanghai
Research Site
Shanghai, Shanghai, China, 200030
China, Zhejiang
Research Site
Hangzhou, Zhejiang, China, 310052
Sponsors and Collaborators
InventisBio Inc.
Layout table for additonal information
Responsible Party: InventisBio Inc.
ClinicalTrials.gov Identifier: NCT03452150    
Other Study ID Numbers: XY-101
First Posted: March 2, 2018    Key Record Dates
Last Update Posted: June 18, 2021
Last Verified: February 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms