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MicroOrganoSphere Drug Screen Pilot Trial in Colorectal Cancer (CRC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05189171
Recruitment Status : Recruiting
First Posted : January 12, 2022
Last Update Posted : December 2, 2022
Sponsor:
Information provided by (Responsible Party):
Xilis, Inc.

Brief Summary:

The primary objective of this study is to determine the feasibility of generating sufficient MicroOrganpSphere (MOS) from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14 days.

The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived.


Condition or disease Intervention/treatment
Colorectal Neoplasms Other: No intervention for this trial.

Detailed Description:

The purpose of this study is to assess the feasibility of creating patient derived models of cancer (i.e., MOS) from patients with colorectal cancer liver metastasis. The investigators of this study focus on a precision medicine strategy for patients with CRC liver metastasis.

Participating subjects will undergo biopsy of patient's liver lesion and the diagnosis of CRC liver metastasis will be verified by pathology. Patients will be treated with standard of care therapy determined by the treating physician. As part of standard of care therapy, patients will undergo lab work including CEA (carcinoembryonic antigen) and CT of the chest, abdomen and pelvis for staging and measurement of tumor size every two months.

Up to 250 patients will be enrolled to the study. Enrolled subjects are defined as subjects who give informed consent. Screen failures are defined as subjects who give informed consent and do not meet eligibility criteria. Accrued subjects are defined as subjects who give informed consent and meet eligibility criteria. Evaluable subjects are defined as those who accrue, receive the study biopsy and have cytologically or histologically confirmed adenocarcinoma of the colon or rectum that is metastatic to the liver. If the biopsy tissue is not confirmed to be adenocarcinoma of the colon or rectum, the subject will be considered non-evaluable and will be replaced.

MOS will be generated from the study biopsy and a drug screen will be performed to determine sensitivity to standard of care therapy. This method has been proven to have a 75% success rate of generating MOS and testing sensitivity to standard of care therapy from tumor biopsy samples.

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Study Type : Observational
Estimated Enrollment : 180 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MicroOrganosphereTM (MOS) Drug Screen to Lead Care (MODEL) Precision Oncology Pilot Trial in Colorectal Cancer (CRC)
Actual Study Start Date : October 25, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
CRC Standard of Care
Colorectal patients with confirmed liver metastasis that has have submitted tumor biopsy sample and receive standard of care therapy.
Other: No intervention for this trial.
The patient will receive standard of care dictated by the treating physician.




Primary Outcome Measures :
  1. Feasibility of generating sufficient MOS from a biopsy of a patient's colorectal cancer [ Time Frame: <14 Days from biopsy ]
    The primary objective of this study is to determine the feasibility of generating sufficient MOS from a biopsy of a patient's colorectal cancer liver metastasis to determine sensitivity to standard of care drug used in the treatment of colorectal cancer (oxaliplatin, irinotecan, 5-FU/Xeloda, Bevacizumab, Panitumumab or Cetuximab, Lonsurf, Regorafenib and Pembrolizumab or Nivolumab) in < 14 days.


Secondary Outcome Measures :
  1. Assess the association between standard of care drug sensitivity in MOS to clinical outcome. [ Time Frame: 2 - 3 Months post biopsy ]
    The secondary objective of this study is to assess the association between standard of care drug sensitivity in MOS to clinical outcome of patient treated with standard of care therapy from which the MOS was derived from.


Biospecimen Retention:   Samples With DNA

A standard of care biopsy of the liver metastasis and a blood draw will be used for the purpose of this trial. Where sample size permits, a portion of the sample will be retained for further evaluation.

A copy of all records and specimens will be retained by Xilis until the data/specimens are exhausted or until the subject withdraws consent. All study documentation will be kept on file for a minimum of six years, or until after the study is completed, whichever is longer. De-identified data and specimens may be kept indefinitely.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will be open to members of all demographic groups who meet the eligibility criteria. A provider known to the patient will introduce the study, and, if the patient is interested, a member of the study team can approach for enrollment. Subjects will not be enrolled without prior approval of their physician (if not a member of the study team). There will be no compensation provided to study participants.
Criteria

Inclusion Criteria:

Subjects may participate in this study if all of the following criteria apply:

  1. Provide written informed consent.
  2. Male or female ages 18 or older.
  3. Evidence of cancer of the colon or rectum that is metastatic to the liver. NOTE: patients may enroll prior to receiving clinical biopsy results. If they are not confirmed to have adenocarcinoma of the colon or rectum that is metastatic to the liver, they will not be evaluable.
  4. Treating physician planning to treat CRC liver metastasis with a standard of care therapy.
  5. Previous adjuvant or neoadjuvant therapies allowed.
  6. Biopsy may be obtained prior to starting the 2nd cycle of a new standard of care therapy.
  7. Measurable disease as measured by RECIST 1.1 criteria.
  8. Life expectancy of ≥ 12 weeks.
  9. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2. 10 Adequate coagulation function as evidenced by:

    1. Absolute neutrophil count ≥ 1.0 x 109/L
    2. Platelets ≥ 50 x 109/L
    3. Hemoglobin >= 8 g/dL (transfusions are permitted to achieve baseline hemoglobin level)
    4. ALT/AST (alanine aminotransferase (ALT) / aspartate aminotransferase (AST)) < 2.5 x upper limit of normal (ULN); or < 5 x ULN in the presence of liver metastases
    5. Total bilirubin < 1.5 x ULN (if total bilirubin >= 1.5 x ULN then the subject may participate if the direct bilirubin is ≤ 1.5 x ULN)
    6. Creatinine clearance > 30 mL/min measured or calculated by Cockcroft-Gault equation or the estimated glomerular filtration rate (GFR) > 30 mL/min/1.73 m2 using the MDRD
    7. INR<1.5

Exclusion Criteria:

Subjects may not participate if any of the following criteria apply:

  1. Chronic or current active infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment.
  2. Clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from day 1 of start of therapy, New York Heart Association Class II, III or IV congestive heart failure, and arrhythmia requiring therapy.
  3. Presence of significant concurrent, uncontrolled medical condition including but not limited to renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, active infection, non-healing wound, or psychiatric disease that excludes them from receiving chemotherapy.
  4. Pregnant or actively breastfeeding women (Pregnant or breastfeeding women are not candidates for chemotherapy).

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): NCT05189171


Contacts
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Contact: Amelia S Zessin +1 (984) 377-6738 clin-ops@xilis.net

Locations
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United States, Arizona
Mayo Clinic Not yet recruiting
Scottsdale, Arizona, United States, 85259
Principal Investigator: Christina S Wu, MD         
United States, District of Columbia
MedStar Washington Hospital Recruiting
Washington, District of Columbia, United States, 20010
Principal Investigator: Anteneh Tesfaye, MD         
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
Principal Investigator: Jeremy Jones, MD         
United States, Louisiana
Louisiana State University Health Sciences Center - New Orleans Recruiting
New Orleans, Louisiana, United States, 70112
Principal Investigator: John Stewart, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Principal Investigator: Joleen Hubbard, MD         
United States, Nevada
Renown Regional Medical Center Recruiting
Reno, Nevada, United States, 89502
Principal Investigator: Lee Schwartzberg, MD         
United States, Tennessee
The University of Tennessee Medical Center Recruiting
Knoxville, Tennessee, United States, 37920
Principal Investigator: James Mosley, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Michael S Lee, MD         
United States, Utah
Intermountain Medical Center Not yet recruiting
Saint George, Utah, United States, 84790
Principal Investigator: Terence Rhodes, MD, PhD         
Sponsors and Collaborators
Xilis, Inc.
Publications:
Barretina J, Caponigro G, Stransky N, Venkatesan K, Margolin AA, Kim S, Wilson CJ, Lehar J, Kryukov GV, Sonkin D, Reddy A, Liu M, Murray L, Berger MF, Monahan JE, Morais P, Meltzer J, Korejwa A, Jane-Valbuena J, Mapa FA, Thibault J, Bric-Furlong E, Raman P, Shipway A, Engels IH, Cheng J, Yu GK, Yu J, Aspesi P Jr, de Silva M, Jagtap K, Jones MD, Wang L, Hatton C, Palescandolo E, Gupta S, Mahan S, Sougnez C, Onofrio RC, Liefeld T, MacConaill L, Winckler W, Reich M, Li N, Mesirov JP, Gabriel SB, Getz G, Ardlie K, Chan V, Myer VE, Weber BL, Porter J, Warmuth M, Finan P, Harris JL, Meyerson M, Golub TR, Morrissey MP, Sellers WR, Schlegel R, Garraway LA. The Cancer Cell Line Encyclopedia enables predictive modelling of anticancer drug sensitivity. Nature. 2012 Mar 28;483(7391):603-7. doi: 10.1038/nature11003. Erratum In: Nature. 2012 Dec 13;492(7428):290. Nature. 2019 Jan;565(7738):E5-E6.
Gao H, Korn JM, Ferretti S, Monahan JE, Wang Y, Singh M, Zhang C, Schnell C, Yang G, Zhang Y, Balbin OA, Barbe S, Cai H, Casey F, Chatterjee S, Chiang DY, Chuai S, Cogan SM, Collins SD, Dammassa E, Ebel N, Embry M, Green J, Kauffmann A, Kowal C, Leary RJ, Lehar J, Liang Y, Loo A, Lorenzana E, Robert McDonald E 3rd, McLaughlin ME, Merkin J, Meyer R, Naylor TL, Patawaran M, Reddy A, Roelli C, Ruddy DA, Salangsang F, Santacroce F, Singh AP, Tang Y, Tinetto W, Tobler S, Velazquez R, Venkatesan K, Von Arx F, Wang HQ, Wang Z, Wiesmann M, Wyss D, Xu F, Bitter H, Atadja P, Lees E, Hofmann F, Li E, Keen N, Cozens R, Jensen MR, Pryer NK, Williams JA, Sellers WR. High-throughput screening using patient-derived tumor xenografts to predict clinical trial drug response. Nat Med. 2015 Nov;21(11):1318-25. doi: 10.1038/nm.3954. Epub 2015 Oct 19.
Tiriac H, Belleau P, Engle DD, Plenker D, Deschênes A, Somerville TDD, Froeling FEM, Burkhart RA, Denroche RE, Jang GH, Miyabayashi K, Young CM, Patel H, Ma M, LaComb JF, Palmaira RLD, Javed AA, Huynh JC, Johnson M, Arora K, Robine N, Shah M, Sanghvi R, Goetz AB, Lowder CY, Martello L, Driehuis E, LeComte N, Askan G, Iacobuzio-Donahue CA, Clevers H, Wood LD, Hruban RH, Thompson E, Aguirre AJ, Wolpin BM, Sasson A, Kim J, Wu M, Bucobo JC, Allen P, Sejpal DV, Nealon W, Sullivan JD, Winter JM, Gimotty PA, Grem JL, DiMaio DJ, Buscaglia JM, Grandgenett PM, Brody JR, Hollingsworth MA, O'Kane GM, Notta F, Kim E, Crawford JM, Devoe C, Ocean A, Wolfgang CL, Yu KH, Li E, Vakoc CR, Hubert B, Fischer SE, Wilson JM, Moffitt R, Knox J, Krasnitz A, Gallinger S, Tuveson DA. Organoid Profiling Identifies Common Responders to Chemotherapy in Pancreatic Cancer. Cancer Discov. 2018 Sep;8(9):1112-1129. doi: 10.1158/2159-8290.CD-18-0349. Epub 2018 May 31.

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Responsible Party: Xilis, Inc.
ClinicalTrials.gov Identifier: NCT05189171    
Other Study ID Numbers: 146057.60
First Posted: January 12, 2022    Key Record Dates
Last Update Posted: December 2, 2022
Last Verified: November 2022
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
Keywords provided by Xilis, Inc.:
Liver Metastasis
Colorectal Cancer
Colon Cancer
CRC liver metastasis
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases