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A Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors

This study is currently recruiting participants.
Verified July 2017 by Boston Biomedical, Inc
Sponsor:
ClinicalTrials.gov Identifier:
NCT02232620
First Posted: September 5, 2014
Last Update Posted: July 11, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Boston Biomedical, Inc
  Purpose

This is an open label, multi-center, phase II study of BBI503 administered to adult patients with advanced gastrointestinal stromal tumor who have exhausted all currently approved standard anti-cancer treatment options. BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily. Cycles will be repeated until patients are no longer clinically benefiting from therapy due to disease progression, adverse events, or another discontinuation criterion.

Safety, tolerability and efficacy of BBI503 will be assessed for the duration of study treatment.


Condition Intervention Phase
Gastrointestinal Stromal Tumors Drug: BBI503 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Study of BBI503 in Adult Patients With Advanced Gastrointestinal Stromal Tumors

Resource links provided by NLM:


Further study details as provided by Boston Biomedical, Inc:

Primary Outcome Measures:
  • Disease Control Rate (DCR) [ Time Frame: 8 weeks ]
    Defined as the proportion of patients with a documented complete response, partial response, and stable disease (CR + PR + SD) based on RECIST 1.1.


Secondary Outcome Measures:
  • Objective Response Rate (ORR) [ Time Frame: 8 weeks ]
    Defined as the proportion of patients with a documented complete response and partial response (CR + PR) based on RECIST 1.1.

  • Progression Free Survival (PFS) [ Time Frame: 24 months ]
    Defined as the time from enrollment to the first objective documentation of disease progression or death due to any cause.

  • Overall Survival (OS) [ Time Frame: 24 months ]
    Defined as the time from enrollment to death due to any cause.

  • Number of Patients with Adverse Events [ Time Frame: 24 months ]
    All patients who have received at least one dose of BBI503 will be included in the safety analysis. The incidence of adverse events will be summarized by type of adverse event and severity.

  • Pharmacodynamics (biomarkers) of BBI503 when tumor biopsy is possible [ Time Frame: baseline, 4 weeks ]

Estimated Enrollment: 30
Actual Study Start Date: March 13, 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BBI503 Drug: BBI503
BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily.
Other Names:
  • Amcasertib
  • BBI-503
  • BB503

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
  • Histologically or cytologically confirmed gastrointestinal stromal tumor that is metastatic, unresectable, or recurrent; and for which no currently approved, standard anti-cancer treatment option is available.
  • ≥ 18 years of age
  • Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Male or female patients of child-producing potential must agree to use contraception or avoidance of pregnancy measures during the study and for 30 days after the last BBI503 dose
  • Females of childbearing potential must have a negative serum pregnancy test
  • Alanine transaminase (ALT) ≤ 2.5 x the upper limit of normal (ULN), or ≤ 3.5 x ULN in the presence of primary or metastatic hepatic lesions
  • Hemoglobin (Hgb) ≥ 10 g/dl
  • Total bilirubin ≤ 1.5 x ULN
  • Creatinine ≤ 1.5 x ULN or creatinine clearance > 50 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal.
  • Absolute neutrophil count ≥ 1.5 x 10^9/L
  • Platelets ≥ 100 x 10^9/L
  • PT ≤ 16 seconds and PTT ≤ 1.5 x ULN
  • Life expectancy ≥ 3 months
  • A patient with gastrointestinal stromal tumor (GIST) must also meet the following criteria:

    • Must have either positive immunostaining for the CD117-antigen, or contain a GIST associated KIT or PDGFR-α mutation.
    • Must have disease which is metastatic or locally advanced and unresectable
    • Must have received prior treatment with imatinib and sunitinib, and must have had disease progression during treatment with these agents, have had documented intolerance to these agents, or not be candidates for treatment with these agents.
    • Must have also failed or not be eligible for treatment with regorafenib.

Exclusion Criteria:

  • Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within 7 days of first dose of BBI503. Patients may begin BBI503 on a date determined by the investigator and medical monitor for the sponsor provided there is a minimum of 7 days since last receiving anti-cancer treatment, and that all prior treatment-related AEs have resolved or have been deemed irreversible.
  • Major surgery within 4 weeks prior to first dose (requiring general anesthesia and/or inpatient hospitalization for recovery).
  • Any known symptomatic or untreated brain metastases requiring increase of steroid dose within 2 weeks prior to starting on study. Patients with treated brain metastases must be stable for 4 weeks after completion of that treatment. Post-treatment image documentation of stability is required within 4 months of starting on study. Patients must have no clinical symptoms from brain metastases and must be either off steroids or on a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients with known leptomeningeal metastases are excluded, even if treated.
  • Pregnant or breastfeeding
  • Significant gastrointestinal disorder(s), in the opinion of the Principal Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small intestine resection)
  • Unable or unwilling to swallow BBI503 capsules daily
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, clinically significant non-healing or healing wounds, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled infection or psychiatric illness/social situations that would limit compliance with study requirements (e.g. no reliable transportation).
  • Patients with a history of malignancies other than the tumor of interest except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for > 3 years.
  • Abnormal ECGs which are clinically significant such as QT prolongation - QTc > 480 msec, clinically significant cardiac enlargement or hypertrophy, new bundle branch block, or signs of active ischemia. Patients with evidence of prior infarction who are New York Heart Association (NYHA) functional class II, III, or IV are excluded, as are patients with marked arrhythmia such as Wolff Parkinson White pattern or complete atrioventricular (AV) dissociation.
  Contacts and Locations
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): NCT02232620


Contacts
Contact: Boston Biomedical 617-674-6800

Locations
Canada, Ontario
Princess Margaret Cancer Centre Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Sukhi Brah, CRC    416-946-4501 ext 3981    sukhi.brah@uhn.ca   
Sponsors and Collaborators
Boston Biomedical, Inc
  More Information

Responsible Party: Boston Biomedical, Inc
ClinicalTrials.gov Identifier: NCT02232620     History of Changes
Other Study ID Numbers: BBI503-205c
First Submitted: September 3, 2014
First Posted: September 5, 2014
Last Update Posted: July 11, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases