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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 : February 10, 2021
Sponsor:
Information provided by (Responsible Party):
InventisBio Inc.

Tracking Information
First Submitted Date  ICMJE February 13, 2018
First Posted Date  ICMJE March 2, 2018
Last Update Posted Date February 10, 2021
Actual Study Start Date  ICMJE January 3, 2018
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
  • Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 - Day 28 ]
    Incidence of DLTs
  • Adverse events [ Time Frame: Day 1 - Day 28 ]
    Incidence of AEs
  • Laboratory results [ Time Frame: Day 1 - Day 28 ]
    Incidence of laboratory abnormalities
  • Vital signs [ Time Frame: Day 1 - Day 28 ]
    Incidence of vital sign abnormalities
  • Electrocardiogram [ Time Frame: Day 1 - Day 28 ]
    Incidence of ECG abnormalities
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2018)
  • 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
  • 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
  • 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
  • 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
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE D-0316 First Time in Patients Ascending Dose Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Advanced Non Small Cell Lung Cancer
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: Daily oral dose of D-0316
Intervention: Drug: D-0316
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 28, 2018)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date May 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03452150
Other Study ID Numbers  ICMJE XY-101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party InventisBio Inc.
Study Sponsor  ICMJE InventisBio Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account InventisBio Inc.
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP