ClinicalTrials.gov

History of Changes for Study: NCT02693535
Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR)
Latest version (submitted May 31, 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 February 23, 2016 None (earliest Version on record)
2 February 25, 2016 Arms and Interventions and Study Status
3 March 10, 2016 Recruitment Status, Study Status, Arms and Interventions, Contacts/Locations and Study Design
4 March 17, 2016 Contacts/Locations, Sponsor/Collaborators, Study Status and Study Identification
5 April 13, 2016 Arms and Interventions, Study Status and Sponsor/Collaborators
6 May 18, 2016 Study Status and Contacts/Locations
7 June 20, 2016 Arms and Interventions, Study Status, Contacts/Locations, Study Design and Sponsor/Collaborators
8 November 16, 2016 Study Status and Contacts/Locations
9 December 14, 2016 Contacts/Locations and Study Status
10 December 16, 2016 Contacts/Locations and Study Status
11 January 5, 2017 Contacts/Locations and Study Status
12 January 26, 2017 Contacts/Locations and Study Status
13 February 28, 2017 Arms and Interventions, Study Status and Eligibility
14 April 7, 2017 Study Status and Contacts/Locations
15 April 28, 2017 Arms and Interventions and Study Status
16 June 26, 2017 Contacts/Locations and Study Status
17 July 19, 2017 Study Description and Study Status
18 August 10, 2017 Eligibility and Study Status
19 August 14, 2017 Study Design and Study Status
20 August 28, 2017 Arms and Interventions and Study Status
21 September 13, 2017 Study Status and Contacts/Locations
22 September 15, 2017 Contacts/Locations and Study Status
23 December 6, 2017 Contacts/Locations and Study Status
24 January 2, 2018 Contacts/Locations and Study Status
25 March 29, 2018 Contacts/Locations and Study Status
26 May 25, 2018 Arms and Interventions, Study Status and Study Design
27 July 9, 2018 Contacts/Locations and Study Status
28 September 10, 2018 Contacts/Locations and Study Status
29 January 24, 2019 Contacts/Locations, Study Status and Study Design
30 February 6, 2019 Study Status and Study Design
31 February 22, 2019 Arms and Interventions and Study Status
32 July 2, 2019 Contacts/Locations, Study Status and Study Design
33 September 11, 2019 Arms and Interventions, Contacts/Locations, Study Status, Eligibility and Sponsor/Collaborators
34 December 12, 2019 Study Status and Study Design
35 February 26, 2020 Contacts/Locations and Study Status
36 February 28, 2020 Study Description and Study Status
37 August 4, 2020 Study Status and Study Description
38 August 18, 2020 Contacts/Locations, Study Description and Study Status
39 October 13, 2020 Contacts/Locations and Study Status
40 October 22, 2020 Study Status and Contacts/Locations
41 December 17, 2020 Study Design and Study Status
42 February 10, 2021 Contacts/Locations and Study Status
43 March 9, 2021 Study Status
44 April 13, 2021 Arms and Interventions, Study Status, Eligibility, Study Design and Sponsor/Collaborators
45 April 21, 2021 Contacts/Locations and Study Status
46 April 26, 2021 Study Design and Study Status
47 May 5, 2021 Study Status and Arms and Interventions
48 May 21, 2021 Study Design and Study Status
49 June 4, 2021 Contacts/Locations and Study Status
50 August 24, 2021 Contacts/Locations and Study Status
51 October 18, 2021 Study Status and Contacts/Locations
52 November 22, 2021 Contacts/Locations and Study Status
53 January 3, 2022 Study Status and Contacts/Locations
54 March 15, 2022 Study Status and Contacts/Locations
55 April 11, 2022 Contacts/Locations and Study Status
56 May 6, 2022 Contacts/Locations and Study Status
57 May 31, 2022 Contacts/Locations and Study Status
Comparison Format:

Scroll up to access the controls

Study NCT02693535
Submitted Date:  February 23, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: Pro00014171
Brief Title: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer (TAPUR)
Official Title: Targeted Agent and Profiling Utilization Registry (TAPUR) Study
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2016
Overall Status: Not yet recruiting
Study Start: March 2016
Primary Completion: March 2019 [Anticipated]
Study Completion:
First Submitted: February 11, 2016
First Submitted that
Met QC Criteria:
February 23, 2016
First Posted: February 26, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 23, 2016
Last Update Posted: February 26, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: American Society of Clinical Oncology
Responsible Party: Sponsor
Collaborators: Eli Lilly and Company
Genentech, Inc.
Pfizer
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: The purpose of the study is to learn from the real world practice of prescribing targeted therapies to patients with advanced cancer whose tumor harbors a genomic variant known to be a drug target or to predict sensitivity to a drug.
Detailed Description: The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the safety and efficacy of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. TAPUR will study Food and Drug Administration (FDA)-approved targeted therapies that are contributed by collaborating pharmaceutical companies, catalogue the choice of molecular profiling test by clinical oncologists and develop hypotheses for additional clinical trials.
Open or close this module Conditions
Conditions: Lymphoma, Non-Hodgkin
Multiple Myeloma
Advanced Solid Tumors
Keywords: cancer
off-label
precision medicine
targeted therapy
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 11
Masking: None (Open Label)
Allocation: Non-Randomized
Enrollment: 680 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Group 1 (VEGFR)
Participants receive axitinib - dosage, frequency and duration per label VEGFR mutation, amplification or overexpression)
Drug: Axitinib
Other Names:
  • Inlyta
Group 2 (Bcr-abl, SRC, LYN, LCK)
Participants receive bosutinib- dosage, frequency and duration per label Bcr-abl, SRC, LYN, LCK mutations
Drug: Bosutinib
Other Names:
  • Bosulif
Group 3 (ALK, ROS1, MET)
Participants receive crizotinib - dosage, frequency and duration per label ALK, ROS1, MET mutations
Drug: Crizotinib
Other Names:
  • Xalkori
Group 4 (CDKN2A/p16, CDK4, CDK6)
Participants receive palbociclib - dosage, frequency and duration per label CDKN2A/p16 loss, CDK4, CDK6 amplifications
Drug: Palbociclib
Other Names:
  • Ibrance
Group 5 (CSF1R, PDGFR, VEGFR)
Participants receive sunitinib - dosage, frequency and duration per label CSF1R, PDGFR, VEGFR mutations
Drug: Sunitinib
Other Names:
  • Sutent
Group 6 (mTOR, TSC)
Participants receive temsirolimus - dosage, frequency and duration per label mTOR, TSC mutations
Drug: Temsirolimus
Other Names:
  • Torisel
Group 7 (EGFR)
Participants receive erlotinib - dosage, frequency and duration per label EGFR mutations
Drug: Erlotinib
Other Names:
  • Tarceva
Group 8 (ERBB2)
Participants receive trastuzumab and pertuzumab - dosage, frequency and duration per label (ERBB2 amplifications)
Drug: Trastuzumab and Pertuzumab
Other Names:
  • Herceptin and Perjeta
Group 9 (BRAFV600E)
Participants receive vemurafenib and cobimetinib - dosage, frequency and duration per label BRAFV600E mutations
Drug: Vemurafenib and Cobimetinib
Other Names:
  • Zelboraf and Cotellic
Group 10 (PTCH1)
Participants receive vismodegib - dosage, frequency and duration per label PTCH1 deletion or inactivating mutations
Drug: Vismodegib
Other Names:
  • Erivedge
Group 11 (KRAS, NRAS and BRAF)
Participants receive cetuximab - dosage, frequency and duration per label KRAS, NRAS and BRAF wildtype
Drug: Cetuximab
Other Names:
  • Erbitux
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Objective Response Rate defined as % of participants in a cohort with complete or partial response or with stable disease according to standard response criteria
[ Time Frame: Assessed at 16 weeks of treatment ]

Each cohort includes participants with the same tumor type, genomic variant and study drug. For solid tumors, the Response Evaluation Criteria for Solid Tumors (RECIST) criteria will be used, for non-Hodgkin Lymphoma, the Lugano Criteria will be used, and for multiple myeloma, the International Uniform Response Criteria for Multiple Myeloma will be used.
Secondary Outcome Measures:
1. Overall survival (OS)
[ Time Frame: Duration of survival from registration on study until death from any cause, assessed throughout end of study, up to 3 years ]

OS will be estimated using the 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:

  • 18 years of age or older
  • Histologically-proven locally advanced or metastatic solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma who is no longer benefitting from standard anti-cancer treatment or for whom, in the opinion of the treating physician, no such treatment is available or indicated
  • Performance status 0-2 (Per Eastern Cooperative Oncology Group (ECOG )criteria)
  • Patients must have acceptable organ function as defined below. However, as noted above, drug-specific inclusion/exclusion criteria specified in the protocol appendix for each agent will take precedence for this and all inclusion criteria:
    1. Absolute neutrophil count ≥ 1.5 x 106/µl
    2. Hemoglobin > 9.0 g/dl
    3. Platelets > 75,000/µl
    4. Total bilirubin < 2.0 mg/ dl
    5. Aspartate aminotransferase (AST) serum glutamic-oxaloacetic transaminase (SGOT) and alanine aminotransferase (ALT) serum glutamic-pyruvic transaminase (SGPT) < 2.5 x institutional upper limit of normal (ULN) (or < 5 x ULN in patients with known hepatic metastases)
    6. Serum creatinine ≤ 1.5 × ULN or calculated or measured creatinine clearance ≥ 50 mL/min/1.73 m2
  • Patients must have measurable or evaluable disease (per RECIST v1.1 for solid tumor, Lugano criteria for non Hodgkin lymphoma or International Myeloma Working Group criteria for multiple myeloma), defined, per RECIST 1.1, as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as ≥20 mm with conventional techniques or as ≥10 mm with spiral computed tomography (CT) scan, Magnetic Resonance Imaging (MRI), or a subcutaneous or superficial lesion that can be measured with calipers by clinical exam. For lymph nodes, the short axis must be ≥15 mm. Patients who have assessable disease by physical or radiographic examination but do not meet these definitions of measurable disease are eligible and will be considered to have evaluable disease. Patient's whose disease cannot be objectively measured by physical or radiographic examination (e.g., elevated serum tumor marker only) are NOT eligible
  • Results must be available from a genomic test or immunohistochemistry (IHC) test for protein expression performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified, College of American Pathologists (CAP) -accredited, New York State accredited (for labs offering services to residents of NY) laboratory that has registered the test with the National Institutes of Health (NIH) Genetic Test Registry or has established an integration with the TAPUR platform. The genomic or IHC test used to qualify a patient for participation in TAPUR may have been performed on any specimen of the patient's tumor obtained at any point during the patient's care at the discretion of the patient's treating physician. Genomic assays performed on cell-free DNA in plasma ("liquid biopsies") will also be acceptable if the genomic analysis is performed in a laboratory that meets the criteria described above.
  • Ability to understand and the willingness to sign a written informed consent document
  • Have a tumor genomic profile for which single agent treatment with one of the FDA approved targeted anti-cancer drugs included in this study has potential clinical benefit based on the criteria described in protocol
  • For orally administered drugs, the patient must be able to swallow and tolerate oral medication and must have no known malabsorption syndrome
  • Because of the risks of drug treatment to the developing fetus, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for four months following completion of study therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study or if she is the partner of a male participant in this study and becomes pregnant while he is participating in this study, she should inform her or her partner's treating physician immediately as well as her obstetrician. Female study patients who become pregnant must immediately discontinue treatment with any study therapy. Male patients should avoid impregnating a female partner. Male study patients, even if surgically sterilized, (i.e. post-vasectomy) must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 4 months after the last dose of study drug, or completely abstain from sexual intercourse

Exclusion Criteria:

  • Patients whose disease is not measurable or cannot be assessed by radiographic imaging or physical examination (e.g., elevated serum tumor marker only) are not eligible
Open or close this module Contacts/Locations
Central Contact Person: Pam Mangat, MS
Telephone: www.tapur.org
Email: pam.mangat@asco.org
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
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