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Trial record 78 of 78 for:    vismodegib

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR)

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ClinicalTrials.gov Identifier: NCT03297606
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : September 6, 2019
Sponsor:
Collaborators:
AstraZeneca
Bristol-Myers Squibb
Hoffmann-La Roche
Pfizer
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Brief Summary:
Cancer drugs which target the effects of abnormal gene changes are called 'targeted therapies'. This study, called PM.1 or CAPTUR, will include some targeted therapies that are currently available. The purpose of this study is to find out what are the effects on a patient and their cancer when they are given a targeted therapy drug that is specific to an abnormal gene change in their cancer.

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Multiple Myeloma Advanced Solid Tumors Drug: Olaparib Drug: Dasatinib Drug: Nivolumab plus Ipilimumab Drug: Axitinib Drug: Bosutinib Drug: Crizotinib Drug: Palbociclib Drug: Sunitinib Drug: Temsirolimus Drug: Erlotinib Drug: Trastuzumab plus Pertuzumab Drug: Vemurafenib plus Cobimetinib Drug: Vismodegib Phase 2

Detailed Description:
Recent advances in laboratory technology have enabled the identification of changes in the genetic makeup of tumors that might be responsible for their malignant behavior such as uncontrolled growth and spread. Some of these changes can be 'druggable', i.e. there may be cancer medicines that can specifically act on the tumour's genetic abnormality. Several cancer centers and programs have initiated this type of molecular profiling across Canada, with the goal to identify 'druggable' changes in tumors to find matching therapy for patients. These include initiatives in British Columbia, Ontario and Quebec. The CAnadian Profiling and Targeted agent Utilization tRial (CAPTUR) will test the activity of a list of commercially available targeted agents in patients who have undergone tumor profiling and have 'druggable' changes identified in their cancers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 720 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR): A Phase II Basket Trial
Actual Study Start Date : October 6, 2017
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
VEGFR1, VEGFR2, VEGFR3
Drug: Axitinib
5mg orally twice daily

Experimental: Group 2
BCR-ABL, SRC
Drug: Bosutinib
500mg orally once daily

Experimental: Group 3
ALK, ROS1, MET
Drug: Crizotinib
250mg orally twice daily

Experimental: Group 4
KIT, PDGFRA, PDGFRB, ABL1
Drug: Dasatinib
100mg administered orally once daily

Experimental: Group 5
EGFR
Drug: Erlotinib
150mg orally, once daily

Experimental: Group 6
high mutation burden, POLE, POLD1
Drug: Nivolumab plus Ipilimumab
  • Combination Phase - 1mg/kg nivolumab administered as an intravenous infusion over 60 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 3mg/kg administered intravenously over 90 minutes, followed by the single-agent phase.
  • Single-Agent Phase - 3mg/kg nivolumab administered as an IV infusion over 60 minutes every 2 weeks.

Experimental: Group 7
BRCA1, BRCA2, mutations in HRD
Drug: Olaparib
300mg taken twice daily

Experimental: Group 8
CDKN2A, CDK4, CDK6, CCND1
Drug: Palbociclib
125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days

Experimental: Group 9
CSF1R, PDGFRA, PDGFRB,VEGFR1, VEGFR2, VEGFR3, KIT, FLT3, RET, FGFR1, FGFR2, FGFR3, VHL
Drug: Sunitinib
50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off

Experimental: Group 10
AKT1, AKT2, AKT3, FBXW7, FLCN, mTOR, NF1, NF2, NTRK3, PIK3CA, PIK3R1, PTEN, RHEB, STKII, TSC1, TSC2
Drug: Temsirolimus
25mg infused over a 30-60 minute period once a week

Experimental: Group 11
ERBB2
Drug: Trastuzumab plus Pertuzumab

Trastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion.

Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes.


Experimental: Group 12
BRAFV600
Drug: Vemurafenib plus Cobimetinib

Vemurafenib = 960 mg orally every 12 hours.

Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest


Experimental: Group 13
PTCH1, SMO
Drug: Vismodegib
150mg taken orally, once daily




Primary Outcome Measures :
  1. Objective response rate defined as the number of patients with complete response or partial response [ Time Frame: 4 years ]
    over the total number of patients in a given cohort.


Secondary Outcome Measures :
  1. Number and severity of adverse events grade >3, or of lesser grade resulting in discontinuation, delay or reduction in dose of study drug [ Time Frame: 4 years ]
    measured by CTCAE

  2. Progression-free survival by disease-appropriate objective criteria [ Time Frame: 4 years ]


Information from the National Library of Medicine

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

Inclusion Criteria: (screening step - non-drug specific)

  • Adult (≥ 18 yrs) patient with a histologically-proven incurable metastatic solid tumour (excluding primary brain tumours), multiple myeloma or B cell non‐Hodgkin lymphoma (excluding CLL, SLL and HCL), for whom there is no standard treatment known to prolong life, or who has refused such treatment.
  • ECOG performance status 0-2.
  • Patients must have normal organ function as follows:

    • Absolute neutrophil count: ≥ 1.5 x 10^9/L for solid tumours; ≥ 1.0 x 10^9/L for neurologic malignancies
    • Platelets ≥ 75 x 10^9/L (or ≥ 50 x 10^9/L if bone marrow involvement by myeloma or lymphoma).
    • Total bilirubin ≤ 1.5 x UNL.
    • AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limit of normal value unless liver metastases are present in which case they must be < 5 x ULN;
    • Serum creatinine ≤ 1.5 x UNL or calculated or measured creatinine clearance ≥ 50mg/min/1.73µ^2
  • Patients must have measurable disease
  • Results must be available from tumour genomic or protein expression testing (if used to identify genetic variants), from one of the initiatives / groups listed in protocol Appendix VII. The test may have been performed on the primary tumour or a metastatic deposit (including bone marrow), or blood, in a diagnostic or research laboratory and must reveal a potentially actionable variant.
  • Patient consent (Main Study Consent for the screening step) must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to the screening step to document their willingness to participate
  • Patients must be accessible for treatment and follow-up. Patients registered on this trial must be treated and followed at the participating centre or a CCTG IND site. This implies there must be reasonable geographical limits (for example: 1 ½ hour's driving distance) placed on patients being considered for this trial.
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method.

Exclusion Criteria: (screening step - non-drug specific)

  • Patients with prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen.
  • Patients with ongoing toxicity ≥ CTCAE grade 2, other than peripheral neuropathy, related to prior anti-tumour treatment. Patients with ongoing peripheral neuropathy of ≥ CTCAE grade 3 will be excluded.
  • Patients concurrently receiving any other anti-cancer therapy (cytotoxic, biologic, radiation, or hormonal other than for replacement) except for medications that are prescribed for supportive care but may potentially have an anti-cancer effect (e.g. megestrol acetate, bisphosphonates) or ongoing castration-intent therapy for prostate cancer. These medications must have been started ≥ one month prior to enrollment on this study. Patients may be on warfarin, low molecular weight heparin or direct factor Xa inhibitors, unless such therapies are prohibited by drug-specific ineligibility criteria.
  • Patients with known active progressive brain metastases. Patients with previously treated brain metastases are eligible, provided that the patient has not experienced a seizure or had a clinically significant change in neurological status within one month prior to screening. All patients with previously treated brain metastases must be stable (clinically and radiologically) for at least one month after completion of treatment and either off steroid treatment or only taking physiological doses of steroids prior to the screening step.
  • Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias, or symptomatic congestive heart failure.
  • Patients with known left ventricular ejection fraction (LVEF) < 40%.
  • Patients with stroke (including TIA) or acute myocardial infarction within three months prior to the screening step.
  • Patients with acute gastrointestinal bleeding within one month prior to the screening step.
  • Patients with any other clinically significant medical condition which, in the opinion of the treating physician, makes it undesirable for the patient to participate in the study or which could jeopardize compliance with study requirements including, but not limited to: ongoing or active infection, significant uncontrolled hypertension, or severe psychiatric illness/social situations.
  • Lactating and nursing women
  • Patients who do not meet drug-specific eligibility requirements for the drug selected by the treating physician.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297606


Contacts
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Contact: Janet Dancey 613-533-6430 jdancey@ctg.queensu.ca

Locations
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Canada, British Columbia
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Daniel John Renouf    604 877-6000 ext 672357      
Canada, Ontario
Kingston Health Sciences Centre Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Kiran Virik    613 649-6666 ext 4502      
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Stephen Welch    519 685-8640      
Ottawa Hospital Research Institute Recruiting
Ottawa, Ontario, Canada, K1H 8L6
Contact: John Hilton    613 737-7700 ext 75086      
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Lillian Siu    416 946-2911      
Canada, Quebec
The Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T 1E2
Contact: Cristiano Ferrario    514 398-8307      
Canada, Saskatchewan
Allan Blair Cancer Centre Recruiting
Regina, Saskatchewan, Canada, S4T 7T1
Contact: Kimberly Hagel    306 766-2691      
Sponsors and Collaborators
Canadian Cancer Trials Group
AstraZeneca
Bristol-Myers Squibb
Hoffmann-La Roche
Pfizer
Investigators
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Study Chair: Lillian Siu Univ. Health Network-OCI/Princess Margaret Hospital, Toronto, ON Canada
Study Chair: Daniel J Renouf BCCA - Vancouver Cancer Centre, Vancouver BC, Canada

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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT03297606     History of Changes
Other Study ID Numbers: PM1
ESR‐17‐12831 ( Other Identifier: AstraZeneca )
CA209‐9DL ( Other Identifier: Bristol-Myers Squibb )
ML39800 ( Other Identifier: Hoffmann-La Roche )
WI233446 ( Other Identifier: Pfizer )
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Myeloma
Lymphoma, Non-Hodgkin
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lymphoma
Lymphatic Diseases
Nivolumab
Trastuzumab
Ipilimumab
Pertuzumab
Sunitinib
Dasatinib
Olaparib
Palbociclib
Vemurafenib
Axitinib
Crizotinib
Antineoplastic Agents, Immunological
Antineoplastic Agents