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Protocol No. ADVL1823

Principal Investigator DeSantes, Kenneth

Phase II

Age Group Both

Scope National

Sponsor Type National

Title Larotrectinib (LOXO-101, NSC# 788607, IND# 141824) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Objective The overall goals of this study are to: Find out what effects, good and/or bad, larotrectinib has on your type of cancer, to learn more about the side effects of larotrectinib and to learn more about how larotrectinib works against cancer cells

Treatment Larotrectinib twice daily orally for up to two years

Description Phase II trial of Larotrectinib (LOXO-101) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias

Key Eligibility
  • Must be 30 years of age or younger
  • Diagnosis: each cohort has specific requirements please contact study coordinators for details
  • Disease status: Corhort A&B require measureable disease as defined by the protocol and Cohort C must have greater than or equal to 5% blasts in the bone marrow
  • Larnsky or Karnofsky performance status greater than or equal to 50
  • Adequate bone marrow, renal, liver and central nervous system function as defined by the protocol
  • Prior therapy: Cohort A & B: No prior anti-cancer therapy, including radiotherapy, other than surgical resection is permitted, Cohort C: relapsed leukemia must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the minimum duration from prior anti-cancer directed therapy prior to enrollment as defined by the protocol
  • Can not be pregnant or breastfeeding
  • Corticosteroids: For solid tumors, including CNS tumors, requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. Patients with leukemia may receive systemic corticosteroids for cytoreduction up to 24 hours prior to the start of protocol therapy. If used to modify immune adverse events related to prior therapy, greater than or equal to 14 days must have elapsed since last dose of corticosteroid
  • Can not be receiving another investigational drugs
  • Anti-cancer Agents: Patients who are currently receiving other anti-cancer agents are not eligible [except leukemia patients receiving corticosteroids or hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy]. Patients with leukemia should receive a single dose of intrathecal cytarabine, hydrocortisone, and/or methotrexate within 7 days prior to Day 1 of Cycle 1 at the time of the baseline lumbar puncture
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant
  • Patients currently receiving a strong CYP3A4 inducer or inhibitor
  • Patients with malabsorption syndrome or other conditions that significantly limit enteral absorption
  • Patients who are unable to swallow capsules or liquid and do not have gastric access via a nasogastric or gastrostomy tube
  • Patients who have an uncontrolled infection
  • Patients who have received prior solid organ transplantation
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study
  • Patients with High Grade Gliomas (HGG)

  • Applicable Disease Sites Anal; Any Site; Bladder; Brain/Central Nervous System; Breast; Cervix; Colon and Rectum; Endocrine cancers; Esophagus; Gastrointestinal cancers, other; Genitourinary cancers, other; Head and Neck; Hematologic cancers, other; Ill-Defined Sites; Kidney; Leukemia; Liver; Lung; Lymphoma; Melanoma/Skin cancer; Multiple Myeloma; Ovary; Pancreas; Prostate; Sarcoma; Stomach; Thyroid; Unknown Sites; Uterus

    Status Open

    Participating Institutions UW Hospital and Clinics