Study of Molecular Profile-Related Evidence to Determine Individualized Therapy for Advanced or Poor Prognosis Cancers

NCT02534675 | Completed DMC

• 1 other identifier: 141758
• Study Type: observational
• Target: 506
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to learn more about personalized cancer therapy including response to treatment and side effects. Information from the patient's medical record regarding the tests and treatments they have received, or will receive, for their cancer will be collected. Genomic testing on tissue from the primary tumor or metastases will be used to match therapy recommendations. Patients in which there is no appropriate matched therapy will receive systemic chemotherapy according to their treating physician's discretion. This information will be used to describe whether or not patients respond better when their physicians choose to treat them according to the genetic makeup of their tumor.

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who receive the molecularly targeted matched treatment after recommendations based on genomic analysis

  Number of patients who received study therapy after recommendations after genetic test versus patients who did not

  3 years

Secondary Outcomes (4)

• Proportion of patients who consent to enroll into the study

  3 years

• Time from informed consent to receipt of genomic analysis

  3 years

• Proportion of patients with actionable genomic alteration

  3 years

• Proportion of patients with insurance coverage for receiving molecularly targeted matched treatment based on genomic analysis

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with incurable malignancies with aggressive biology

You may qualify if:

• Patients with incurable malignancies with more than 50% 2-year cancer-associated mortality (as estimated by two physician and where appropriate according to 2014 National Cancer database)
• Diseases include, but are not limited to:
• Ampullary carcinoma Intrahepatic cholangiocarcinoma (IHCC) Appendiceal cancer Melanoma Colorectal cancer (CRC) Non-KIT GIST (gastrointestinal stromal tumor) Extrahepatic cholangiocarcinoma (EHCC) Non-small cell lung cancer (NSCLC) Esophageal adenocarcinoma Ovarian cancer Gallbladder cancer (GBCA) Pancreatic ductal adenocarcinoma (PDAC) Gastric adenocarcinoma Sarcoma (high-grade) Head and neck cancer Small bowel adenocarcinoma (including duodenal) Hepatocellular carcinoma (HCC) Triple-negative breast cancer (TNBC) Urothelial cancer
• Patients with incurable malignancies, irrespective of 2-year mortality, who, in the opinion of the investigator have no treatment option expected to yield significant clinical benefit."
• Patients must have at least one of the following for a diagnosis/disease status:
• Unresectable disease
• Metastatic disease
• Medically unfit for surgical resection but with an expected survival of \> 3 months, ECOG \< 2 and NYHA status ≤ II (refer to status definitions in tables below)
• Disease where no conventional therapy leads to a survival benefit \> 6 months in the respective cohort and line of therapy for which the patient is otherwise eligible
• Actionable alterations determined by FoundationOneTM
• Treatment naïve for his or her newly diagnosed malignancy for enrollment to Groups 1 or 2.
• Status post 1 or more unmatched systemic therapy regimens for enrollment to Group 3.
• Ability to understand and the willingness to sign a written informed consent.
• Patients must have measurable disease for malignancies: defined 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 CT scan, PET-CT, MRI, or calipers by clinical exam.
• Age ≥ 18 years.

You may not qualify if:

• Two oncologists disagree on prognosis or resectability.
• Severe or uncontrolled medical disorder that would, in the investigator's opinion, confound study analyses of treatment response (i.e., uncontrolled diabetes, chronic renal disease, chronic pulmonary disease or active, uncontrolled infection, psychiatric illness/social situations that would limit compliance with study requirements).
• Are pregnant or breast-feeding patients or any patient with childbearing potential not using adequate pregnancy prevention (site-specific criteria applying to Avera only).

Sponsors & Collaborators

• University of California, San Diego: lead
• Foundation Medicine: collaborator

Study Sites (2)

UCSD Moores Cancer Center

La Jolla, California, 92093, United States

Location

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

Location

Related Publications (2)

• Noh S, Sharma AK, Fanta PT, Kato S, Kurzrock R, Sicklick JK. Personalized N-of-1 Combination Therapies for Advanced Gastrointestinal Stromal Tumors. JCO Precis Oncol. 2025 Jul;9:e2500066. doi: 10.1200/PO-25-00066. Epub 2025 Jul 23.

  PMID: 40700673 DERIVED

• Sicklick JK, Kato S, Okamura R, Patel H, Nikanjam M, Fanta PT, Hahn ME, De P, Williams C, Guido J, Solomon BM, McKay RR, Krie A, Boles SG, Ross JS, Lee JJ, Leyland-Jones B, Lippman SM, Kurzrock R. Molecular profiling of advanced malignancies guides first-line N-of-1 treatments in the I-PREDICT treatment-naive study. Genome Med. 2021 Oct 4;13(1):155. doi: 10.1186/s13073-021-00969-w.

  PMID: 34607609 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Primary tumor tissue or metastases

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jason Sicklick, MD and Razelle Kurzrock, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Surgery

Study Record Dates

• First Submitted: August 25, 2015
• First Posted: August 28, 2015
• Study Start: February 1, 2015
• Primary Completion: December 17, 2020
• Study Completion: December 1, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

US (2)