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 (Fusions) (STARTRK-2)

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Study Record Versions

Version	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:

Merged
Side-by-Side

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 (Fusions) (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:

Study Status


Record Verification:	June 2016
Overall Status:	Recruiting
Study Start:	October 2015
Primary Completion:	October 2017 [Anticipated]
Study Completion:	October 2018 [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:	July 5, 2016
Last Update Posted:	July 7, 2016 [Estimate]

Sponsor/Collaborators


Sponsor:	Hoffmann-La Roche
Responsible Party:	Sponsor
Collaborators:

Oversight


U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:	Yes

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:

Conditions

Conditions:

Breast Cancer
Cholangiocarcinoma
Colorectal Cancer
Head and Neck Neoplasms
Lymphoma, Large-Cell, Anaplastic
Melanoma
Neuroendocrine Tumors
Non-Small Cell Lung Cancer
Ovarian Cancer
Pancreatic Cancer
Papillary Thyroid Cancer
Primary Brain Tumors
Renal Cell Carcinoma
Sarcomas
Salivary Gland Cancers
Adult Solid Tumor

Keywords:

Entrectinib
RXDX-101
TrkA
TrkB
TrkC
NTRK1
NTRK2
NTRK3
ROS1
ALK
Trk Fusions
NTRK Gene Rearrangements
ROS1 Fusions
ROS1 Gene Rearrangements
ALK Fusions
ALK Gene Rearrangements
Basket study
Non-small cell lung cancer
Colorectal cancer
Salivary gland cancers
Primary brain tumors
Melanoma
Sarcomas
Papillary thyroid cancer
Renal cell cancer
Pancreatic cancer
Breast cancer
Cholangiocarcinoma
Head & Neck cancers
Ovarian cancer
Neuroendocrine tumors
Anaplastic Large Cell Lymphoma

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]

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

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

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 For patients enrolled via local molecular testing, an archival or fresh tumor tissue (unless medically contraindicated) is required to be submitted for independent central molecular testing at Ignyta's CLIA laboratory post-enrollment Measurable or evaluable 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

Contacts/Locations


Central Contact Person:	Ignyta Inc. Telephone: 1-844-782-7875 Email: STARTRKtrials@ignyta.com
Study Officials:	Edna Chow Maneval, PhD Study Director Hoffmann-La Roche
Locations:	United States, Alabama
	Northwest Alabama Cancer Center [Recruiting] Muscle Shoals, Alabama, United States, 35661 Contact:Contact: Hemant Patel, MD
	United States, Arizona
	Cancer Treatment Centers of America [Recruiting] Goodyear, Arizona, United States, 85338 Contact:Contact: Glen Weiss, MD
	United States, California
	City of Hope Cancer Center [Recruiting] Duarte, California, United States, 91010 Contact:Contact: Marwan Fakih, MD
	Scripps Clinic Medical Group [Recruiting] La Jolla, California, United States, 92037 Contact:Contact: Darren Sigal, MD
	University of California San Diego Moores Cancer Center [Recruiting] La Jolla, California, United States, 92093 Contact:Contact: Lyudmila Bazhenova, MD
	University of California, Irvine College of Medicine [Recruiting] Orange, California, United States, 92868 Contact:Contact: Tara Seery, MD
	Southern California Kaiser Permanente [Recruiting] Panorama City, California, United States, 91402 Contact:Contact: Jonathan Polikoff, MD
	UCSF Mount Zion Medical Center [Recruiting] San Francisco, California, United States, 94143 Contact:Contact: Collin Blakely, MD
	Sarcoma Oncology Research Center LLC [Recruiting] Santa Monica, California, United States, 90403 Contact:Contact: Kamalesh Sankhala, MD
	St. Joseph Heritage Healthcare [Recruiting] Santa Rosa, California, United States, 95403 Contact:Contact: Ian Anderson, MD
	United States, Colorado
	University of Colorado Cancer Center [Recruiting] Aurora, Colorado, United States, 80045 Contact:Contact: Robert Doebele, MD
	United States, District of Columbia
	Georgetown University - Lombardi Comprehensive Cancer Center [Recruiting] Washington, District of Columbia, United States, 20007 Contact:Contact: Stephen Liu, MD
	United States, Florida
	H. Lee Moffitt Cancer Center and Research Institute, Inc. [Recruiting] Tampa, Florida, United States, 33612 Contact:Contact: Eric Haura, MD
	Cleveland Clinic Florida - Maroone Cancer Center [Recruiting] Weston, Florida, United States, 33331 Contact:Contact: Thomas Samuel, MD
	United States, Georgia
	University Cancer & Blood Center, LLC [Recruiting] Athens, Georgia, United States, 30607 Contact:Contact: Petros Nikolinakos, MD
	Winship Cancer Institute [Recruiting] Atlanta, Georgia, United States, 30322 Contact:Contact: Conor Steuer, MD
	Cancer Treatment Centers of America [Recruiting] Newnan, Georgia, United States, 30265 Contact:Contact: Ioana Bonta, MD
	United States, Hawaii
	University of Hawaii Cancer Center [Recruiting] Honolulu, Hawaii, United States, 96813 Contact:Contact: Jared Acoba, MD
	United States, Illinois
	Oncology Specialists, S.C. [Recruiting] Park Ridge, Illinois, United States, 60068 Contact:Contact: Arthur Hooberman, MD
	Cancer Treatment Centers of America [Recruiting] Zion, Illinois, United States, 60099 Contact:Contact: Eugene Ahn, MD
	United States, Indiana
	Floyd Memorial Cancer Center [Recruiting] New Albany, Indiana, United States, 47150 Contact:Contact: Naveed Chowhan, MD
	United States, Massachusetts
	Massachusetts General Hospital / Beth Israel Deaconess Med Ctr [Recruiting] Boston, Massachusetts, United States, 02114 Contact:Contact: Anna Farago, MD
	United States, Michigan
	University of Michigan Comprehensive Cancer Center [Recruiting] Ann Arbor, Michigan, United States, 48109 Contact:Contact: John Krauss, MD
	Karmanos Cancer Center [Recruiting] Detriot, Michigan, United States, 48201 Contact:Contact: Shirish Gadgeel, MD
	Henry Ford Health System [Recruiting] Detroit, Michigan, United States, 48202 Contact:Contact: Ding Wang, MD
	United States, Minnesota
	University of Minnesota [Recruiting] Minneapolis, Minnesota, United States, 55455 Contact:Contact: Manish Patel, MD
	United States, Missouri
	Washington University School of Medicine [Recruiting] St. Louis, Missouri, United States, 63110 Contact:Contact: Saiama Waqar, MD
	United States, New Hampshire
	Dartmouth-Hitchcock Medical Center [Recruiting] Lebanon, New Hampshire, United States, 03756 Contact:Contact: Mary Chamberlin, MD
	United States, New York
	North Shore Hematology Oncology Associates, PC [Recruiting] East Setauket, New York, United States, 11733 Contact:Contact: David Chu, MD
	Northern Westchester Hospital Association [Recruiting] Mount Kisco, New York, United States, 10549 Contact:Contact: Jonathan Goldberg, MD
	Memorial Sloan Kettering Cancer Center [Recruiting] New York, New York, United States, 10022 Contact:Contact: Alexander Drilon, MD
	United States, Ohio
	Cleveland Clinic [Recruiting] Cleveland, Ohio, United States, 44195 Contact:Contact: Dale Shepard, MD
	OSU - James Comprehensive Cancer Center [Recruiting] Columbus, Ohio, United States, 43210 Contact:Contact: Gregory Otterson, MD
	United States, Oklahoma
	Cancer Treatment Centers of America [Recruiting] Tulsa, Oklahoma, United States, 74133 Contact:Contact: Theodore Pollock, MD
	United States, Oregon
	Oregon Health & Science University [Recruiting] Portland, Oregon, United States, 97239 Contact:Contact: Matthew Taylor, MD
	United States, Pennsylvania
	Cancer Treatment Centers of America [Recruiting] Philadelphia, Pennsylvania, United States, 19124 Contact:Contact: Pamela Crilley, MD
	United States, Texas
	Mary Crowley Cancer Research Center [Recruiting] Dallas, Texas, United States, 75230 Contact:Contact: John Nemunaitis, MD
	United States, Utah
	Huntsman Cancer Institute [Recruiting] Salt Lake City, Utah, United States, 84112 Contact:Contact: Ignacio Garrido-Laguna, MD
	United States, Virginia
	Virginia Cancer Specialists, PC [Recruiting] Fairfax, Virginia, United States, 22031 Contact:Contact: Alexander Spira, MD
	United States, Washington
	University of Washington - Seattle Cancer Care Alliance [Recruiting] Seattle, Washington, United States, 98109 Contact:Contact: Elena Chiorean, MD
	United States, Wisconsin
	Wheaton Franciscan Cancer Care-All Saints [Recruiting] Franklin, Wisconsin, United States, 53132 Contact:Contact: Jonathan Treisman, MD
	Australia, New South Wales
	Newcastle Private Hospital [Recruiting] New Lambton Heights, New South Wales, Australia, 2035 Contact:Contact: Dr. Maria Aslam
	Australia, Victoria
	Border Medical Oncology [Recruiting] Wodonga, Victoria, Australia, 3690 Contact:Contact: Dr. Craig Underhill
	Belgium
	Antwerp University Hospital [Recruiting] Edegem, Belgium, 2650 Contact:Contact: Dr. Christian Rolfo
	Korea, Republic of
	Severance Hospital [Recruiting] Seoul, Korea, Republic of, 120-752 Contact:Contact: Dr. Byoung Chul Cho
	Singapore
	National University Hospital [Recruiting] Kent Ridge, Singapore, 119074 Contact:Contact: Dr. Cheng Ean Chee
	United Kingdom
	The Christie NHS Foundation Trust [Recruiting] Manchester, United Kingdom, M20 4BX Contact:Contact: Dr. Emma Dean
	United Kingdom, Cambridgeshire
	Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital [Recruiting] Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ Contact:Contact: Dr. Simon Pacey

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