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Integrated Molecular Profiling in Advanced Cancers Trial (IMPACT)

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ClinicalTrials.gov Identifier: NCT01505400
Recruitment Status : Active, not recruiting
First Posted : January 6, 2012
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Tracking Information
First Submitted Date January 4, 2012
First Posted Date January 6, 2012
Last Update Posted Date November 15, 2018
Study Start Date February 2012
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 5, 2012)
Molecular profiling data to be made available in patient's electronic medical records. [ Time Frame: 1 month ]
Genotyping assays including: AKT1, HRAS, AKT2, JAK2, AKT3, KIT, BRAF, KRAS, CDK, MEK1, CTNNB1, MET, EGFR, NOTCH1, ERBB2, NRAS, FGFR1, PDGFRA, FGFR2, PIK3CA, FGFR3, RET, FGFR4, SMO, STK11
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01505400 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 5, 2012)
  • Utilization rates of molecular profiling information [ Time Frame: 1 year ]
    Including utilization of information for standard regimens or clinical trials of molecularly targeted therapies.
  • Clinical trial accrual rates among patients with available molecular profiling data [ Time Frame: 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Integrated Molecular Profiling in Advanced Cancers Trial
Official Title Integrated Molecular Profiling in Advanced Cancers Trial
Brief Summary

Substantial progress has been made in the treatment of cancer through the use of targeted therapies, but what works for one patient might not work for another patient. Certain drugs are now being developed that target specific molecules in the body that are believed to be part of the disease.

Biomarkers are specific characteristics of the cancer that may help provide prognostic information (i.e. how well patients will be regardless of the treatments given) or help predict sensitivity or resistance to a specific treatment.

The study will collect archival tumor samples (previously collected biopsy or surgical tumor samples) to provide biomarker data about a patient's cancer, in order to help their physicians to identify which clinical trials of molecularly targeted therapies may be most appropriate for the patient in the future.

Detailed Description

The increasing appreciation and identification of specific somatic mutations and other genetic aberrations that drive cancers leave us on the threshold of a new era of "personalized cancer medicine", in which specific biomarkers will be used to direct targeted agents only to those patients deemed most likely to respond. The potential medical, scientific and economic benefits of such a personalized approach to cancer therapy are immense and self-evident. Yet despite some important advances, only a limited number of approved targeted agents have had their approvals predicated on specific biomarkers of sensitivity or resistance.

The premises behind personalized cancer medicine include: i) genetic aberrations exist in human malignancies; ii) a subset of these aberrations, often present across multiple cancer types, have functional relevance as "hallmarks" or "drivers" for oncogenesis and tumor progression; iii) such genetic aberrations are potentially "druggable" targets; and iv) there are tolerable medicinal compounds that can effectively modulate such targets. A key requirement of this new, personalized approach to anti-cancer therapy is that specific patients must be matched to a particular drug or combination of drugs. Molecular profiling of tumors to identify somatic mutations and/or other genetic aberrations are examples of enrichment strategies to assist in matching patients to drugs or treatments that have gained increasing interest in the oncology community.

The present protocol seeks to provide molecular profiling data to the treating physician for patients with advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas, as well as patients who are phase I trial candidates, in order to help identify which standard regimens or clinical trials of molecularly targeted therapies may be most appropriate for the individual patient.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Archival tumor tissue

1 tube of whole blood

Sampling Method Probability Sample
Study Population Advanced cancers (breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas) and phase 1 clinical trial candidates
Condition
  • Breast Cancer
  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Genitourinary Cancer
  • Pancreatobiliary Gastrointestinal Cancer
  • Upper Aerodigestive Tract Cancer
  • Gynecological Cancers
  • Melanoma Cancers
  • Rare Cancers
  • Unknown Primary Cancers
Intervention Not Provided
Study Groups/Cohorts Advanced cancer
Advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas; as well as patients who are phase I trial candidates
Publications * Stockley TL, Oza AM, Berman HK, Leighl NB, Knox JJ, Shepherd FA, Chen EX, Krzyzanowska MK, Dhani N, Joshua AM, Tsao MS, Serra S, Clarke B, Roehrl MH, Zhang T, Sukhai MA, Califaretti N, Trinkaus M, Shaw P, van der Kwast T, Wang L, Virtanen C, Kim RH, Razak AR, Hansen AR, Yu C, Pugh TJ, Kamel-Reid S, Siu LL, Bedard PL. Molecular profiling of advanced solid tumors and patient outcomes with genotype-matched clinical trials: the Princess Margaret IMPACT/COMPACT trial. Genome Med. 2016 Oct 25;8(1):109.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: August 19, 2016)
3026
Original Estimated Enrollment
 (submitted: January 5, 2012)
500
Estimated Study Completion Date February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients with histological confirmation of advanced breast, non-small cell lung, colorectal, genitourinary, pancreatobiliary gastrointestinal, upper aerodigestive tract, gynecological, melanoma, unknown primary, and rare carcinomas who are candidates for systemic therapy, as well as patients who are phase I trial candidates.
  • Patient must be ≥ 18 years old.
  • Patient's ECOG performance status equal to 0 or 1.
  • All patients must have signed and dated an informed consent form.
  • All patients must have sufficient archived tumor tissue for molecular profiling.

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT01505400
Other Study ID Numbers IMPACT-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University Health Network, Toronto
Study Sponsor University Health Network, Toronto
Collaborators Princess Margaret Hospital, Canada
Investigators
Principal Investigator: Philippe Bedard, MD Princess Margaret Hospital, Canada
PRS Account University Health Network, Toronto
Verification Date November 2018