ClinicalTrials.gov
History of Changes for Study: NCT02568267
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK1/2/3, ROS1, or ALK Gene Rearrangements (STARTRK-2)
Latest version (submitted March 27, 2024) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 October 2, 2015 None (earliest Version on record)
2 October 14, 2015 Recruitment Status, Study Status and Contacts/Locations
3 October 20, 2015 Study Status, Outcome Measures and Conditions
4 October 27, 2015 Conditions, Study Status and Study Identification
5 October 29, 2015 Contacts/Locations, Conditions and Study Status
6 January 19, 2016 Contacts/Locations, Study Status and Eligibility
7 January 25, 2016 Contacts/Locations and Study Status
8 February 8, 2016 Contacts/Locations and Study Status
9 February 16, 2016 Contacts/Locations and Study Status
10 February 22, 2016 Contacts/Locations, Conditions and Study Status
11 March 4, 2016 Study Status and Contacts/Locations
12 March 10, 2016 Contacts/Locations and Study Status
13 March 18, 2016 Contacts/Locations and Study Status
14 March 29, 2016 Contacts/Locations and Study Status
15 April 7, 2016 Contacts/Locations and Study Status
16 May 16, 2016 Study Status and Contacts/Locations
17 June 2, 2016 Contacts/Locations and Study Status
18 June 8, 2016 Contacts/Locations and Study Status
19 June 13, 2016 Contacts/Locations and Study Status
20 June 16, 2016 Contacts/Locations and Study Status
21 June 30, 2016 Contacts/Locations and Study Status
22 July 5, 2016 Contacts/Locations and Study Status
23 July 13, 2016 Contacts/Locations and Study Status
24 July 17, 2016 Study Status and Contacts/Locations
25 August 1, 2016 Study Status and Contacts/Locations
26 August 2, 2016 Contacts/Locations and Study Status
27 August 4, 2016 Contacts/Locations and Study Status
28 August 10, 2016 Contacts/Locations and Study Status
29 August 25, 2016 Contacts/Locations and Study Status
30 August 26, 2016 Contacts/Locations and Study Status
31 August 31, 2016 Contacts/Locations and Study Status
32 September 13, 2016 Contacts/Locations and Study Status
33 September 16, 2016 Contacts/Locations and Study Status
34 September 20, 2016 Contacts/Locations, Eligibility, Outcome Measures, Study Description, Study Status and Study Identification
35 September 23, 2016 Contacts/Locations and Study Status
36 September 26, 2016 Contacts/Locations and Study Status
37 September 28, 2016 Contacts/Locations and Study Status
38 October 5, 2016 Contacts/Locations and Study Status
39 October 10, 2016 Contacts/Locations and Study Status
40 October 12, 2016 Contacts/Locations and Study Status
41 October 24, 2016 Contacts/Locations and Study Status
42 November 2, 2016 Contacts/Locations and Study Status
43 November 8, 2016 Contacts/Locations and Study Status
44 November 9, 2016 Contacts/Locations and Study Status
45 November 18, 2016 Contacts/Locations and Study Status
46 November 28, 2016 Contacts/Locations and Study Status
47 December 7, 2016 Study Status and Contacts/Locations
48 December 15, 2016 Contacts/Locations and Study Status
49 December 19, 2016 Contacts/Locations, Study Status and Study Identification
50 December 22, 2016 Contacts/Locations and Study Status
51 January 3, 2017 Study Status and Contacts/Locations
52 January 20, 2017 Contacts/Locations and Study Status
53 January 27, 2017 Contacts/Locations and Study Status
54 February 1, 2017 Study Status and Contacts/Locations
55 February 24, 2017 Contacts/Locations and Study Status
56 March 16, 2017 Study Status and Contacts/Locations
57 March 21, 2017 Contacts/Locations and Study Status
58 March 27, 2017 Contacts/Locations and Study Status
59 March 30, 2017 Contacts/Locations and Study Status
60 April 5, 2017 Study Status and Contacts/Locations
61 April 20, 2017 Contacts/Locations and Study Status
62 May 8, 2017 Study Status and Contacts/Locations
63 May 17, 2017 Contacts/Locations and Study Status
64 May 22, 2017 Study Status
65 June 26, 2017 Contacts/Locations and Study Status
66 June 29, 2017 Contacts/Locations and Study Status
67 July 5, 2017 Study Status and Contacts/Locations
68 July 24, 2017 Contacts/Locations and Study Status
69 August 1, 2017 Contacts/Locations and Study Status
70 August 14, 2017 Contacts/Locations and Study Status
71 August 21, 2017 Contacts/Locations and Study Status
72 August 30, 2017 Contacts/Locations and Study Status
73 September 6, 2017 Study Status and Contacts/Locations
74 September 14, 2017 Contacts/Locations and Study Status
75 October 2, 2017 Study Status and Contacts/Locations
76 October 10, 2017 Contacts/Locations and Study Status
77 November 6, 2017 Study Status and Contacts/Locations
78 December 4, 2017 Contacts/Locations and Study Status
79 February 8, 2018 Study Status and Contacts/Locations
80 June 13, 2018 Study Status, Contacts/Locations and Study Identification
81 July 16, 2018 Study Status
82 July 19, 2018 Contacts/Locations and Study Status
83 August 17, 2018 Contacts/Locations and Study Status
84 October 31, 2018 Study Status and Contacts/Locations
85 December 12, 2018 Contacts/Locations and Study Status
86 January 14, 2019 Contacts/Locations and Study Status
87 February 18, 2019 Contacts/Locations and Study Status
88 March 21, 2019 Study Status
89 May 2, 2019 Study Status and Contacts/Locations
90 June 4, 2019 Study Status and Contacts/Locations
91 July 9, 2019 Contacts/Locations and Study Status
92 August 9, 2019 Contacts/Locations and Study Status
93 August 29, 2019 Eligibility, Arms and Interventions and Study Status
94 October 7, 2019 Contacts/Locations and Study Status
95 November 19, 2019 Study Status and Contacts/Locations
96 January 8, 2020 Contacts/Locations and Study Status
97 February 4, 2020 Study Status and Contacts/Locations
98 March 23, 2020 Study Status and Contacts/Locations
99 April 30, 2020 Contacts/Locations and Study Status
100 June 1, 2020 Study Status and Contacts/Locations
101 June 26, 2020 Contacts/Locations and Study Status
102 August 4, 2020 Study Status and Contacts/Locations
103 September 17, 2020 Study Status and Contacts/Locations
104 October 20, 2020 Study Status, Contacts/Locations, Eligibility, Outcome Measures and Study Design
105 November 12, 2020 Contacts/Locations and Study Status
106 January 19, 2021 Contacts/Locations and Study Status
107 March 18, 2021 Contacts/Locations, Study Status, Eligibility and Study Design
108 June 4, 2021 Oversight, Study Status, Contacts/Locations, Eligibility and Conditions
109 July 16, 2021 Contacts/Locations and Study Status
110 August 26, 2021 Contacts/Locations and Study Status
111 October 26, 2021 Study Status and Contacts/Locations
112 January 10, 2022 Contacts/Locations and Study Status
113 February 8, 2022 Study Status and Contacts/Locations
114 March 4, 2022 Contacts/Locations and Study Status
115 April 1, 2022 Study Status and Contacts/Locations
116 May 1, 2022 Study Status and Contacts/Locations
117 May 31, 2022 Contacts/Locations and Study Status
118 June 27, 2022 Study Status and Contacts/Locations
119 July 26, 2022 Study Status
120 August 24, 2022 Study Status
121 September 22, 2022 Study Status
122 October 17, 2022 Study Status
123 November 14, 2022 Recruitment Status, Study Status and Contacts/Locations
124 February 6, 2023 Contacts/Locations, Study Design and Study Status
125 April 20, 2023 Contacts/Locations and Study Status
126 July 13, 2023 Study Status
127 October 5, 2023 Study Status and Contacts/Locations
128 January 2, 2024 Contacts/Locations and Study Status
129 March 27, 2024 Study Status
Comparison Format:
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Study NCT02568267
Submitted Date:  October 2, 2015 (v1)
Open or close this module Study Identification
Unique Protocol ID: RXDX-101-02
Brief Title: Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK1/2/3, ROS1, or ALK Gene Rearrangements (STARTRK-2)
Official Title: An Open-Label, Multicenter, Global Phase 2 Basket Study of Entrectinib for the Treatment of Patients With Locally Advanced or Metastatic Solid Tumors That Harbor NTRK1/2/3, ROS1, or ALK Gene Rearrangements
Secondary IDs:
Open or close this module Study Status
Record Verification: October 2015
Overall Status: Not yet recruiting
Study Start: October 2015
Primary Completion: June 2017 [Anticipated]
Study Completion: September 2017 [Anticipated]
First Submitted: October 2, 2015
First Submitted that
Met QC Criteria:		 October 2, 2015
First Posted: October 5, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:		 October 2, 2015
Last Update Posted: October 5, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Hoffmann-La Roche
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: Yes
Open or close this module Study Description
Brief Summary: This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene rearrangement. Patients will be assigned to different baskets according to tumor type and gene rearrangement. NSCLC and mCRC will be the main patient populations of interest
Detailed Description:
Open or close this module Conditions
Conditions: Solid Tumors
Keywords: RXDX-101
Entrectinib
Phase 2
Open-label
NTRK1/2/3
ROS1
ALK gene rearrangements
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Parallel Assignment
Number of Arms: 9
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 300 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: NTRK1/2/3-rearranged NSCLC
Oral entrectinib (RXDX-101)
 Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Names:
  • RXDX-101
Experimental: ROS1-rearranged NSCLC
Oral entrectinib (RXDX-101)
 Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Names:
  • RXDX-101
Experimental: ALK- or ROS1-rearranged NSCLC

with CNS-only progression previously treated with crizotinib

Oral entrectinib (RXDX-101)

 Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Names:
  • RXDX-101
Experimental: NTRK/1/2/3-rearranged mCRC
Oral entrectinib (RXDX-101)
 Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Names:
  • RXDX-101
Experimental: ROS1-rearranged mCRC
Oral entrectinib (RXDX-101)
 Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Names:
  • RXDX-101
Experimental: ALK-rearranged mCRC
Oral entrectinib (RXDX-101)
 Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Names:
  • RXDX-101
Experimental: NTRK1/2/3-rearranged other solid tumor
Oral entrectinib (RXDX-101)
 Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Names:
  • RXDX-101
Experimental: ROS1-rearranged other solid tumor
Oral entrectinib (RXDX-101)
 Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Names:
  • RXDX-101
Experimental: ALK-rearranged other solid tumor
Oral entrectinib (RXDX-101)
 Drug: Entrectinib
TrkA/B/C, ROS1, and ALK inhibitor
Other Names:
  • RXDX-101
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective Response Rate
[ Time Frame: Approximately 24 months ]

Assessed by blinded independent central review (BICR) using RECIST v1.1
Secondary Outcome Measures:
1. Duration of Response
[ Time Frame: Approximately 24 months ]

Assessed by blinded independent central review (BICR) using RECIST v1.1
2. Time to Response
[ Time Frame: Approximately 24 months ]

Assessed by blinded independent central review (BICR) using RECIST v1.1
3. Clinical Benefit Rate
[ Time Frame: Approximately 24 months ]

Assessed by blinded independent central review (BICR) using RECIST v1.1
4. Intracranial Tumor Response
[ Time Frame: Approximately 24 months ]

Assessed by blinded independent central review (BICR) using RANO-BM
5. CNS Progression-free Survival
[ Time Frame: Approximately 24 months ]

Assessed by blinded independent central review (BICR) using RANO-BM
6. Progression-free Survival
[ Time Frame: Approximately 36 months ]

Assessed by Kaplan-Meier method
7. Overall Survival
[ Time Frame: Approximately 36 months ]

Assessed by Kaplan-Meier method
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor that harbors an NTRK1/2/3, ROS1, or ALK gene rearrangement

    - Note: Patients diagnosed with anaplastic large cell lymphoma (ALCL) harboring a gene rearrangement of interest may be eligible provided they meet all other inclusion/exclusion criteria

  • Measurable disease
  • Patients with CNS involvement, including leptomeningeal carcinomatosis, which is either asymptomatic or previously-treated and controlled, are allowed
  • Prior anticancer therapy is allowed (excluding approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements)

    - Note: prior treatment with crizotinib is permitted in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression

  • At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed after prior chemotherapy or small molecule targeted therapy
  • At least 4 weeks must have elapsed since completion of antibody-directed therapy
  • Prior radiotherapy is allowed if more than 14 days have elapsed since the end of treatment
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Adequate organ function as defined per protocol
  • Ability to swallow entrectinib intact
  • Other protocol specified criteria

Exclusion Criteria:

  • Current participation in another therapeutic clinical trial
  • Prior treatment with approved or investigational Trk, ROS1, or ALK inhibitors in patients who have tumors that harbor those respective gene rearrangements

    - Note: prior treatment with crizotinib is permitted in ALK- or ROS1-rearranged NSCLC patients presenting with CNS-only progression

  • History of other previous cancer that would interfere with the determination of safety or efficacy
  • Incomplete recovery from any surgery
  • History of non-pharmacologically induced prolonged QTc interval
  • History of additional risk factors for torsade de pointes
  • Peripheral neuropathy Grade ≥ 2
  • Known active infections
  • Active gastrointestinal disease or other malabsorption syndromes
  • Known interstitial lung disease, interstitial fibrosis, or history of tyrosine kinase inhibitor-induced pneumonitis
  • Other protocol specified criteria
Open or close this module Contacts/Locations
Central Contact Person: Lisa Schechet
Telephone: 858-332-0785
Email: lschechet@ignyta.com
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links:
Available IPD/Information:
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