ClinicalTrials.gov

History of Changes for Study: NCT03093116
A Study of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
Latest version (submitted September 27, 2022) on ClinicalTrials.gov
  • A study version is represented by a row in the table.
  • Select two study versions to compare. One each from columns A and B.
  • Choose either the "Merged" or "Side-by-Side" comparison format to specify how the two study versions are to be displayed. The Side-by-Side format only applies to the Protocol section of the study.
  • Click "Compare" to do the comparison and show the differences.
  • Select a version's Submitted Date link to see a rendering of the study for that version.
  • The yellow A/B choices in the table indicate the study versions currently compared below. A yellow table row indicates the study version currently being viewed.
  • Hover over the "Recruitment Status" to see how the study's recruitment status changed.
  • Study edits or deletions are displayed in red.
  • Study additions are displayed in green.
Study Record Versions
Version A B Submitted Date Changes
1 March 21, 2017 None (earliest Version on record)
2 March 27, 2017 Outcome Measures and Study Status
3 April 14, 2017 Study Status and Contacts/Locations
4 May 10, 2017 Study Status and Contacts/Locations
5 August 9, 2017 Study Status and Contacts/Locations
6 July 11, 2018 Contacts/Locations and Study Status
7 March 4, 2019 Contacts/Locations, Study Status and Oversight
8 April 9, 2019 Arms and Interventions, Outcome Measures, Study Status, Contacts/Locations, Study Description, Study Identification, Eligibility, Study Design and Conditions
9 April 10, 2019 Arms and Interventions, Study Design and Study Status
10 May 28, 2019 Study Status and Outcome Measures
11 June 24, 2019 Contacts/Locations, Outcome Measures, Study Status, Eligibility, Arms and Interventions, Study Description and Conditions
12 July 11, 2019 Contacts/Locations and Study Status
13 August 6, 2019 Study Status and Contacts/Locations
14 August 29, 2019 Contacts/Locations and Study Status
15 September 6, 2019 Contacts/Locations and Study Status
16 September 13, 2019 Study Status and Contacts/Locations
17 September 24, 2019 Contacts/Locations and Study Status
18 September 27, 2019 Contacts/Locations and Study Status
19 October 14, 2019 Contacts/Locations and Study Status
20 October 18, 2019 Contacts/Locations and Study Status
21 November 8, 2019 Contacts/Locations and Study Status
22 November 27, 2019 Contacts/Locations and Study Status
23 December 2, 2019 Contacts/Locations and Study Status
24 December 6, 2019 Contacts/Locations and Study Status
25 December 19, 2019 Contacts/Locations and Study Status
26 January 2, 2020 Contacts/Locations and Study Status
27 January 22, 2020 Study Status and Contacts/Locations
28 January 23, 2020 Contacts/Locations and Study Status
29 February 4, 2020 Contacts/Locations and Study Status
30 February 13, 2020 Contacts/Locations and Study Status
31 February 20, 2020 Contacts/Locations and Study Status
32 March 2, 2020 Study Status and Contacts/Locations
33 March 11, 2020 Contacts/Locations and Study Status
34 March 18, 2020 Contacts/Locations and Study Status
35 March 25, 2020 Contacts/Locations and Study Status
36 March 31, 2020 Contacts/Locations and Study Status
37 April 1, 2020 Study Status and Contacts/Locations
38 April 6, 2020 Contacts/Locations and Study Status
39 April 14, 2020 Contacts/Locations and Study Status
40 April 16, 2020 Contacts/Locations and Study Status
41 April 20, 2020 Contacts/Locations and Study Status
42 April 22, 2020 Contacts/Locations and Study Status
43 April 24, 2020 Contacts/Locations and Study Status
44 June 9, 2020 Contacts/Locations, Study Description, Study Status, Eligibility and Arms and Interventions
45 June 16, 2020 Contacts/Locations and Study Status
46 June 26, 2020 Contacts/Locations and Study Status
47 July 7, 2020 Study Status and Contacts/Locations
48 July 9, 2020 Contacts/Locations and Study Status
49 July 27, 2020 Contacts/Locations and Study Status
50 August 12, 2020 Study Status and Contacts/Locations
51 August 14, 2020 Contacts/Locations and Study Status
52 August 28, 2020 Contacts/Locations and Study Status
53 September 16, 2020 Study Status and Contacts/Locations
54 September 17, 2020 Contacts/Locations and Study Status
55 September 23, 2020 Contacts/Locations and Study Status
56 October 5, 2020 Contacts/Locations and Study Status
57 December 16, 2020 Study Status, Eligibility, Arms and Interventions and Study Description
58 December 17, 2020 Contacts/Locations and Study Status
59 January 13, 2021 Study Status and Contacts/Locations
60 January 27, 2021 Contacts/Locations and Study Status
61 January 29, 2021 Contacts/Locations and Study Status
62 November 3, 2021 Contacts/Locations, Study Status and Study Design
63 November 15, 2021 Contacts/Locations and Study Status
64 November 29, 2021 Contacts/Locations and Study Status
65 February 10, 2022 Contacts/Locations and Study Status
66 February 22, 2022 Contacts/Locations and Study Status
67 March 11, 2022 Contacts/Locations, Sponsor/Collaborators and Study Status
68 March 23, 2022 Study Status and Contacts/Locations
69 March 23, 2022 Contacts/Locations and Study Status
70 April 29, 2022 Contacts/Locations and Study Status
71 May 25, 2022 Study Status and Contacts/Locations
72 June 1, 2022 Study Status and Contacts/Locations
73 June 16, 2022 Contacts/Locations and Study Status
74 July 8, 2022 Contacts/Locations and Study Status
75 August 3, 2022 Study Status and Contacts/Locations
76 August 11, 2022 Contacts/Locations and Study Status
77 September 2, 2022 Study Status and Contacts/Locations
78 September 13, 2022 Contacts/Locations and Study Status
79 September 15, 2022 Contacts/Locations and Study Status
80 September 27, 2022 Contacts/Locations and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT03093116
Submitted Date:  March 21, 2017 (v1)

Open or close this module Study Identification
Unique Protocol ID: TPX-0005-01
Brief Title: A Study of TPX-0005 in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements (TRIDENT-1)
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)
Secondary IDs:
Open or close this module Study Status
Record Verification: March 2017
Overall Status: Recruiting
Study Start: February 27, 2017
Primary Completion: January 2021 [Anticipated]
Study Completion: December 2021 [Anticipated]
First Submitted: March 6, 2017
First Submitted that
Met QC Criteria:
March 21, 2017
First Posted: March 28, 2017 [Actual]
Last Update Submitted that
Met QC Criteria:
March 21, 2017
Last Update Posted: March 28, 2017 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Turning Point Therapeutics, Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: Yes
U.S. FDA-regulated Device: No
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary:

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.

Detailed Description:
Open or close this module Conditions
Conditions: Locally Advanced Solid Tumors
Metastatic Solid Tumors
Non Hodgkin Lymphoma
Keywords: ALK Gene Rearrangement
ROS1 Gene Rearrangement
NTRK 1/2/3 Gene Rearrangement
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1/Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 450 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: TPX-0005
Oral TPX-0005
Drug: Oral TPX-0005
Oral TPX-0005 capsules.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Define the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D)
[ Time Frame: Within 28 days of the first TPX-0005 dose for each patient. ]

To determine the MTD and RP2D.
2. 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:
1. 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.
2. To determine the time to response (TTR)
[ Time Frame: Approximately three years. ]

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

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

• To determine the CBR of TPX-0005.
5. To determine the progression free survival (PFS).
[ Time Frame: Approximately three years. ]

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

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

• To determine the intracranial objective response rate.
8. To determine the CNS progression-free survival.
[ Time Frame: Approximately three years. ]

• To determine the CNS progression-free survival.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
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.
Open or close this module Contacts/Locations
Central Contact Person: TP Therapeutics, Inc.
Telephone: +1 (858) 276-0005
Email: clinical@tptherapeutics.com
Study Officials: John KC Lim, Pharm.D.
Study Director
Turning Point Therapeutics, Inc.
Locations: United States, California
UC Irvine Health, Chao Family Comprehensive Cancer Center
[Recruiting]
Orange, California, United States, 92868
Contact:Contact: Susanna Searcy 877-827-8839 ucstudy@uci.edu
United States, New York
Memorial Sloan Kettering Cancer Center
[Recruiting]
New York, New York, United States, 10065
Contact:Contact: Deepa Ramaswami 646-888-4425 ramaswad@mskcc.org
Contact:Contact: Judy Nguyen (646) 888-4425 Nguyenj2@mskcc.org
Open or close this module IPDSharing
Plan to Share IPD: No
There are no plans to share individual participant data with other researchers.
Open or close this module References
Links:
Available IPD/Information:

Scroll up to access the controls Scroll to the Study top

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services