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A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer

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ClinicalTrials.gov Identifier: NCT03471663
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : June 25, 2018
Sponsor:
Information provided by (Responsible Party):
InventisBio Inc.

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE March 20, 2018
Last Update Posted Date June 25, 2018
Actual Study Start Date  ICMJE March 18, 2018
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
Incidence of AEs meeting protocol defined dose-limiting toxicities (DLTs) criteria [ Time Frame: Approximately 2 years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03471663 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
  • Maximum observed serum concentration (Cmax) [ Time Frame: Cycle 1 (28 days) ]
  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] [ Time Frame: Cycle 1 (28 days) ]
  • Time of maximum observed concentration (Tmax) [ Time Frame: Cycle 1 (28 days) ]
  • Objective response rate (ORR) [ Time Frame: up to 12 months ]
  • Progression free survival (PFS) [ Time Frame: up to 12 months ]
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 A First-in-Human Study of D-0502 Alone and in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
Official Title  ICMJE A Phase I, Open-Label Study of D-0502 Single Agent and D-0502 in Combination With Palbociclib in Women With Advanced or Metastatic ER-Positive and HER2-Negative Breast Cancer
Brief Summary This is a phase I, open-label study of D-0502 single agent and D-0502 in combination with standard dose of palbociclib to assess the safety and tolerability, identify an MTD, and/or RP2D, evaluate the PK properties and evaluate preliminary anti-tumor activities in women with advanced or metastatic ER-positive, HER2-negative breast cancer.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: D-0502
    oral tablets
  • Drug: palbociclib
    standard dose of palbociclib
Study Arms  ICMJE
  • Experimental: D-0502
    D-0502
    Intervention: Drug: D-0502
  • Experimental: D-0502 in combination with palbociclib
    D-0502 in combination with palbociclib
    Interventions:
    • Drug: D-0502
    • Drug: palbociclib
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2018)
57
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Histologically-proven, ER-positive, HER2-negative locally advanced, inoperable, and/or metastatic breast cancer.
  2. Female patients with menopausal status:

    i. Postmenopausal status defined as meeting at least one of the following criteria:

    1. Have undergone a bilateral oophorectomy any time in life;
    2. Age ≥60 years, or
    3. Age <60 years but have cessation of regular menses ≥12 months with follicle stimulating hormone (FSH) value >40 milli-international units per milliliter (mIU/mL) and an estradiol value <40 picograms per milliliter (pg/mL) (140 picomoles per liter [pmol/L]).

    ii. Premenopausal or perimenopausal concurrently given a luteinizing hormone-releasing hormone (LHRH) agonist starting at least 4 weeks before the start of trial therapy and is planned to continue LHRH agonist during the study.

  3. Patients meeting all the following criteria:

    1. Has had at least 6 months of endocrine therapy for metastatic ER+ breast cancer prior to disease progression;
    2. Receipt of ≤ 2 lines of prior chemotherapy for metastatic disease;
    3. Radiological or objective evidence of disease progression on or after the last systemic therapy prior to starting current study treatment.
    4. For phase Ia: Not eligible for standard therapy that would confer clinical benefit to the patient.

Exclusion Criteria:

  1. Patients with prior anticancer or investigational drug treatment within the following windows are excluded:

    1. Tamoxifen therapy less than 6 weeks before first dose of study treatment.
    2. For phase Ib: fulvestrant or other selective estrogen receptor degraders (SERD) such as RAD1901, AZD9496, LSZ102, GDC0927 and H3B-6545 therapy less than 6 months before first dose of study treatment.
    3. Any other anti-cancer endocrine therapy less than 30 days before first dose of study treatment.
    4. Any other investigational drug therapy less than 28 days or 4 half-lives (whichever is longer) or non-resolved toxicity such hematology issue prior to first dose of study treatment.
  2. Patients with untreated or symptomatic or progressive central nervous system (CNS) metastases.
  3. Patients with endometrial disorders, including evidence of endometrial hyperplasia, dysfunctional uterine bleeding or cysts.

    • Other protocol defined inclusion/exclusion criteria could apply
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shi Zhe, PhD 86-21-5003661 zhe.shi@inventisbio.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03471663
Other Study ID Numbers  ICMJE IBIO-301
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
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 June 2018

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