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A Study of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

This study is currently recruiting participants.
See Contacts and Locations
Verified August 2017 by TP Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
TP Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT03093116
First received: March 6, 2017
Last updated: August 9, 2017
Last verified: August 2017
  Purpose

Phase 1 will assess safety and tolerability of TPX-0005 via a standard dose escalation scheme, and determine the recommended phase 2 dose.

Phase 2 will assess safety and efficacy of TPX-0005.


Condition Intervention Phase
Locally Advanced Solid Tumors Metastatic Solid Tumors Non Hodgkin Lymphoma Drug: Oral TPX-0005 Phase 1 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Multi-Center, First-in-Human Study of the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)

Resource links provided by NLM:


Further study details as provided by TP Therapeutics, Inc.:

Primary Outcome Measures:
  • Define the Maximum Tolerated Dose (MTD) [ Time Frame: Within 28 days of the first TPX-0005 dose for each patient. ]
    To determine the MTD.

  • Define the Recommended Phase 2 Dose (RP2D) [ Time Frame: Within 28 days of the first TPX-0005 dose for each patient. ]
    To determine the RP2D.

  • Overall Response Rate (ORR) [ Time Frame: Two to three months after starting treatment for each patient. ]
    To determine the ORR of TPX-0005 as assessed by Blinded Independent Central Review.


Secondary Outcome Measures:
  • To determine the effect of food on the AUC of TPX-0005. [ Time Frame: Two to three months after starting treatment for each patient. ]
    To determine the effect of food on the AUC of TPX-0005.

  • To determine the time to response (TTR) [ Time Frame: Approximately three years. ]
    • To determine the TTR of TPX-0005.

  • To determine the duration of response (DOR) [ Time Frame: Approximately three years. ]
    • To determine the DOR of TPX-0005.

  • To determine the clinical benefit rate (CBR) [ Time Frame: Approximately three years. ]
    • To determine the CBR of TPX-0005.

  • To determine the progression free survival (PFS). [ Time Frame: Approximately three years. ]
    • To determine the PFS.

  • To determine the overall survival (OS). [ Time Frame: Approximately three years. ]
    • To determine the OS.

  • To determine the intracranial objective response rate. [ Time Frame: Approximately three years. ]
    • To determine the intracranial objective response rate.

  • To determine the CNS progression-free survival. [ Time Frame: Approximately three years. ]
    • To determine the CNS progression-free survival.


Estimated Enrollment: 450
Actual Study Start Date: February 27, 2017
Estimated Study Completion Date: December 2021
Estimated Primary Completion Date: January 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TPX-0005
Oral TPX-0005
Drug: Oral TPX-0005
Oral TPX-0005 capsules.

  Eligibility

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

Key Inclusion Criteria:

  1. Histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor (including non-Hodgkin Lymphoma) (Stage IV, AJCC v.7) that harbors an ALK, ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement by protocol specified tests.
  2. ECOG PS 0-1.
  3. Age ≥18 (or age ≥ 20 of age as required by local regulation).
  4. At least 1 measurable target lesion according to RECIST version 1.1. CNS-only measurable disease as defined by RECIST version 1.1 is allowed.
  5. Prior cytotoxic chemotherapy is allowed.
  6. Prior immunotherapy is allowed.
  7. Resolution of all acute toxic effects (excluding alopecia) of any prior anti-cancer therapy to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 4.03 Grade less than or equal to 1.
  8. Patients with asymptomatic CNS involvement are allowed.
  9. Life expectancy ≥ 3 months.

Key Exclusion Criteria:

  1. Concurrent participation in another therapeutic clinical trial.
  2. Symptomatic CNS involvement.
  3. Any of the following cardiovascular history in the past 6 months: myocardial infarction, unstable angina, coronary/ peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, pulmonary embolism, deep vein thrombosis, symptomatic bradycardia, requirement for anti-arrhythmic medication.
  4. History of prolonged QTc interval.
  5. Known active infections (bacterial, fungal, viral including HIV positivity).
  6. Gastrointestinal disease (e.g., Crohn's disease, ulcerative colitis, or short gut syndrome) or other malabsorption syndromes that would impact drug absorption.
  7. Peripheral neuropathy ≥ Grade 2.
  8. Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis. Patients with a history of prior radiation pneumonitis are not excluded.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03093116

Contacts
Contact: TP Therapeutics, Inc. +1 (858) 276-0005 clinical@tptherapeutics.com

Locations
United States, California
UC Irvine Health, Chao Family Comprehensive Cancer Center Recruiting
Orange, California, United States, 92868
Contact: Susanna Searcy    877-827-8839    ucstudy@uci.edu   
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Paula Fisk    720-848-0676    paula.fisk@ucdenver.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Alice T Shaw, M.D., Ph.D.    617-724-4000    ashaw1@partners.org   
United States, New York
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Deepa Ramaswami    646-888-4425    ramaswad@mskcc.org   
Contact: Judy Nguyen    (646) 888-4425    Nguyenj2@mskcc.org   
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Dong-Wan Kim, M.D., Ph.D.    +82-2-2072-2995    kimdw@snu.ac.kr   
Yonsei Cancer Center, Severance Hospital Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Byoung Chul Cho, M.D., Ph.D.    +82-2-2228-8126    cbc1971@yuhs.ac   
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Jeeyun Lee, M.D., Ph.D.    +82-2-3410-3459    jyun.lee@samsung.com   
Sponsors and Collaborators
TP Therapeutics, Inc.
Investigators
Study Director: John KC Lim, Pharm.D. TP Therapeutics, Inc.
  More Information

Responsible Party: TP Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03093116     History of Changes
Other Study ID Numbers: TPX-0005-01
Study First Received: March 6, 2017
Last Updated: August 9, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There are no plans to share individual participant data with other researchers.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by TP Therapeutics, Inc.:
ALK Gene Rearrangement
ROS1 Gene Rearrangement
NTRK 1/2/3 Gene Rearrangement

Additional relevant MeSH terms:
Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on August 22, 2017