Advanced Colorectal CarcinomaPhase 1NCT04535401
Testing the Addition of an Anticancer Drug, BAY 1895344, to the Usual Chemotherapy With FOLFIRI in Advanced or Metastatic Cancers of the Stomach and Intestines
A Phase 1 study testing Biopsy Procedure, Biospecimen Collection and Diagnostic Imaging Testing in people with Advanced Colorectal Carcinoma and Advanced Digestive System Carcinoma, run by National Cancer Institute (NCI) at 10 sites in United States.
Trial summary
This phase I trial investigates the best dose, possible benefits and/or side effects of BAY 1895344 in combination with FOLFIRI in treating patients with stomach or intestinal cancer that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Colorectal Carcinoma, Advanced Digestive System Carcinoma, Advanced Gastric Carcinoma
- What is being tested?
- Biopsy Procedure, Biospecimen Collection and Diagnostic Imaging Testing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 10 sitesUnited States
- Study dates
- 13 Aug 2021to 1 Jul 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For Dose Escalation: Patients must have histologically or cytologically confirmed advanced or metastatic gastrointestinal (GI) cancers with Response Evaluation Criteria in Solid Tumors 1.1 (RECIST1.1) measurable disease who have progressed on at least one prior treatment for metastatic disease and for whom FOLFIRI is considered a reasonable treatment option. Patients with mismatch repair deficiency should have progressed on immunotherapy
- For Dose Expansion: Patients must have either:
- Colorectal cancer who have previously progressed on irinotecan and tolerated an irinotecan dose equal to or greater than the recommended phase 2 dose (RP2D). If they have mismatch repair deficiency they should have progressed on immunotherapy OR
- Gastroesophageal cancer who have progressed on at least one first-line therapy for metastatic disease. If they have mismatch repair deficiency they should have progressed on immunotherapy
- For Dose Expansion: Patients be willing to undergo biopsies for research purposes only. The accessible tumor can be the primary or metastatic tumor site. Both research biopsies should be taken from the same tumor site
- Patients must have progressive disease on at least first-line therapy for metastatic disease. Previous treatment with irinotecan is allowed
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- Age >= 18 years. Because no dosing or adverse event data are currently available on the use of BAY 1895344 in combination with FOLFIRI in patients <18 years of age, children are excluded from this study
- Eastern Cooperative Oncology Group (ECOG) performance status =< 1
- Leukocytes >= 3,000/mcL
- Absolute neutrophil count >= 1,500/mcL
- Platelets >= 100,000/mcL
- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 3 x institutional ULN
- Glomerular filtration rate (GFR) >= 60 mL/min/1.73 m^2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
- International normalization ratio (INR) =< 1.5 × ULN unless participant is receiving anticoagulant therapy, in which case prothrombin time (PT) or activated partial thromboplastin time (aPTT) should be within expected therapeutic range of anticoagulants. If patient has a new diagnosis of venous thromboembolism (VTE), then patient should be appropriately anticoagulated with low molecular weight heparin (LMWH) or direct acting oral anticoagulants (DOACs) and be clinically stable for at least 1 week post treatment onset
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy, that does not interact with study therapy, with undetectable viral load within 6 months are eligible for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy that does not interact with study therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load and HCV therapy does not interact with study therapy
- Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression
- Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
- The effects of BAY 1895344 on the developing human fetus are unknown. For this reason and because DNA-damage response inhibitors agents as well as other therapeutic agents used in this trial, 5-FU and irinotecan, are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation and for 6 months after completion of BAY 1895344 administration
- Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of study treatment administration
- Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity (IDMC) who have a legally-authorized representative (LAR) and/or family member available will also be eligible
Who cannot join
- Patients with a history of prior treatment with an ATR inhibitor
- Patients with a history of other malignancy that could affect compliance with the protocol or interpretation of the results
- Patients who have had chemotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study
- Patients who have not recovered from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities > grade 1) with the exception of alopecia
- Patients who are receiving any other investigational agents
- History of hypersensitivity or allergic reactions attributed to compounds of similar chemical or biologic composition to BAY 1895344, 5-FU, leucovorin, or irinotecan. Patient eligibility can be discussed with the primary investigator (PI) if prior reactions do not seem to warrant excluding the patient
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- Patients receiving any medications that are substrates of CYP3A4 with a narrow therapeutic window or strong inhibitors/inducers of CYP3A4 are ineligible, if they cannot be transferred to alternative medication. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product
- Patients with uncontrolled intercurrent illness
- Patients with psychiatric illness/social situations that would limit compliance with study requirements
- Gastrointestinal pathology or history that adversely impact the ability to take or absorb oral medication
- Pregnant women are excluded from this study because BAY 1895344 as a DNA-damage response inhibitor may have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with BAY 1895344 breastfeeding should be discontinued if the mother is treated with BAY 1895344 and for 4 months after end of treatment. These potential risks may also apply to other agents used in this study
- Patients who were unable to tolerate prior irinotecan treatment are excluded from this study
- Patients with a corrected QT (QTc) interval >= 470 msec are excluded from this study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
National Cancer Institute Developmental Therapeutics Clinic
Bethesda, Maryland, 20892
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, 63376
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, 63141
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Washington University School of Medicine
St Louis, Missouri, 63110
Siteman Cancer Center-South County
St Louis, Missouri, 63129
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, 63136
About this study
Official title: Phase I/Ib Trial of ATR Inhibitor BAY 1895344 in Combination With FOLFIRI in GI Malignancies With a Focus on Metastatic Colorectal and Gastric/Gastroesophageal Cancers
This phase I trial investigates the best dose, possible benefits and/or side effects of BAY 1895344 in combination with FOLFIRI in treating patients with stomach or intestinal cancer that that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started (primary site) to other places in the body (metastatic). BAY 1895344 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as irinotecan, fluorouracil, and leucovorin, (called FOLFIRI in short) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving BAY 1895344 in combination with FOLFIRI may help shrink advanced or metastatic stomach and/or intestinal cancer.
Read the detailed description
PRIMARY OBJECTIVE:
- Determine the safety and maximum tolerated dose (MTD) of elimusertib (BAY 1895344) with leucovorin calcium, fluorouracil, and irinotecan hydrochloride (FOLFIRI).
SECONDARY OBJECTIVES:
- To observe and record anti-tumor activity by overall response rate (ORR), progression-free survival (PFS), and overall survival (OS).
II. Determine the response and clinical benefit rate (complete response + partial response + stable disease) of BAY 1895344 with FOLFIRI in colorectal and gastric/gastroesophageal cancers.
III. Evaluate tumor and peripheral blood mononuclear cell (PBMC) deoxyribonucleic acid (DNA) damage signaling in the context of the chemotherapy backbone alone and when combined with BAY 1895344.
IV. Evaluate the pharmacokinetics (PK) profile of fluorouracil (5-FU) and irinotecan.
- Evaluate the PK profile of BAY 1895344. VI. Evaluate the relationship between ATM status by immunohistochemistry (IHC) and clinical efficacy of the BAY 1895344/FOLFIRI combination.
EXPLORATORY OBJECTIVES:
- Evaluate the exposure-response relationship between drug exposures and toxicity and response, and UGT1A1 genotype.
II. Evaluate the relationship between tumor mutations and clinical efficacy of the BAY 1895344/FOLFIRI combination.
OUTLINE: This is a dose-escalation study of elimusertib, irinotecan, and fluorouracil with fixed-dose leucovorin followed by a dose-expansion study.
Patients receive elimusertib orally (PO) once daily (QD) on days 2, 3, 16, and 17 and irinotecan hydrochloride intravenously (IV) over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study.
After completion of study treatment, patients are followed up for 30 days and then every 3 months for up to 1 year or until their disease gets worse or they begin a new treatment for their cancer.
- Conditions
- Advanced Colorectal Carcinoma, Advanced Digestive System Carcinoma, Advanced Gastric Carcinoma, Advanced Gastroesophageal Junction Adenocarcinoma, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Being tested
- Biopsy Procedure, Biospecimen Collection, Diagnostic Imaging Testing, Elimusertib, Fluorouracil
- Medical subject headings
- Colorectal Neoplasms, Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biopsy ProcedureProcedure or surgery
Also called Biopsy, BIOPSY_TYPE, Bx
Undergo tumor biopsy
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection
Undergo blood sample collection
Diagnostic Imaging TestingProcedure or surgery
Also called Diagnostic Imaging, Medical Imaging
Undergo imaging
ElimusertibDrug
Also called ATR Inhibitor BAY1895344, ATR Kinase Inhibitor BAY1895344, BAY 1895344, BAY-1895344
Given PO
FluorouracilDrug
Also called 5 Fluorouracil, 5 Fluorouracilum, 5 FU, 5-Fluoro-2,4(1H, 3H)-pyrimidinedione
Given IV
Also called Campto, Camptosar, Camptothecin 11, Camptothecin-11
Given IV
Also called Adinepar, Calcifolin, Calcium (6S)-Folinate, Calcium Folinate
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Treatment (elimusertib, FOLFIRI) | Experimental | Patients receive elimusertib PO QD on days 2, 3, 16, and 17 and irinotecan hydrochloride IV over 90 minutes, fluorouracil IV over 46 hours, and leucovorin calcium IV on days 1 and 15. Cycles repeat every 28 day in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy during screening and on study and blood sample collection and imaging throughout the study. Receives: Procedure: Biopsy Procedure; Procedure: Biospecimen Collection; Procedure: Diagnostic Imaging Testing; Drug: Elimusertib; Drug: Fluorouracil; Drug: Irinotecan Hydrochloride; Drug: Leucovorin Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Tolerated Dose (MTD) of Elimusertib (BAY 1895344) in Combination With Irinotecan, Fluorouracil, and Leucovorin (FOLFIRI)
A BOIN - Bayesian Optimal intervals trial design will be used to determine the MTD.
Measured: Up to 28 days
Patients Who Experienced DLTs
Percentage of Patients Who Experienced Dose Limiting Toxicities (DLTs) , per CTCAE v5.0
Measured: Up to 28 days
Secondary outcomes (27)
Cmax of Irinotecan (Lead in)
Concentration Maximum (Cmax) of irinotecan and 5FU in Lead-in phase.
Measured: Up to 1 year post treatment
AUC of Irinotecan (Lead in)
Area Under the Curve (AUC) of irinotecan and 5FU in Lead-in phase.
Measured: Up to 1 year post treatment
AUC of 5FU (Lead-in)
Area Under the Curve (AUC) of irinotecan and 5FU in Lead-in phase.
Measured: Up to 1 year post treatment
Cmax of Irinotecan (Combination)
Concentration Maximum (Cmax) of irinotecan in Combination (BAY + 5FU and Irinotecan) phase.
Measured: Up to 1 year post treatment
AUC of Irinotecan (Combination)
Area Under the Curve (AUC) of irinotecan in Combination (BAY + 5FU and Irinotecan) phase.
Measured: Up to 1 year post treatment
AUC of 5FU (Combination)
Area Under the Curve (AUC) of 5FU in Combination (BAY + 5FU and Irinotecan) phase
Measured: Up to 1 year post treatment
Cmax of BAY 1895344
Concentration maximum (Cmax) of BAY 1895344.
Measured: Up to 1 year post treatment
AUC-6 of BAY 1895344
Area Under the Curve of BAY 1895344.
Measured: Up to 1 year post treatment
AUC of BAY 1895344
AUC of BAY 1895344
Measured: Up to 1 year post treatment
Overall Response Rate (ORR)
Percent probability of Complete Response (CR) or Partial Response (PR) per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Up to 1 year post treatment
Clinical Benefit Rate (CBR)
Percent probability of Complete Response (CR), Partial Response (PR) or Stable Disease (SD) per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters.
Measured: Up to 1 year post treatment
Best Response
Number of patients with Complete Response (CR), Partial Response (PR), Stable Disease (SD) or Progressive Disease (PD) per RECIST v1.1, CR: Disappearance of all target lesions. Any pathological lymph nodes (target or non-target) with reduction in short axis to <10 mm; PR: ≥30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters or SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. PD: At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: Up to 1 year post treatment
Progression-free Survival (PFS) - by Dose Level
Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: Up to 24 months post treatment
12-month Progression-free Survival (PFS) - by Dose Level
Proportion of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: At 12 months
24-month Progression-free Survival (PFS) - by Dose Level
Proportion of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: At 24 months
Progression-free Survival (PFS) - Total Population
Median PFS will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions. Measured from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: Up to 24 months post treatment
12-month Progression-free Survival (PFS) - Total Population
Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: At 12 months
24-month Progression-free Survival (PFS) - Total Population
Percentage of patients with Progression-free survival (PFS) will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of progression or death, whichever occurs first. Per RECIST v1.1 Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
Measured: At 24 months
Overall Survival (OS) - by Dose Level
Median number of months patients are alive from start of treatment until death while on study will be estimated within disease cohorts (KM estimator), with 95% CI.
Measured: Up to 24 months post treatment
12- Month Overall Survival (OS) - By Dose Level
Proportion of patients alive estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of death.
Measured: At 12 months
24-month Overall Survival (OS)
Proportion of patients alive estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment to time of death while on study.
Measured: At 24 months
Overall Survival (OS) - Total Population
Median number of months patients alive from start of treatment until death while on study will be estimated within disease cohorts by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions.
Measured: Up to 2 years post treatment
12-month Overall Survival (OS) - Total Population
Proportion of patients alive estimated by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment.
Measured: At 12 months
24-month Overall Survival (OS) - Total Population
Proportion of patients alive estimated by the product-limit (Kaplan-Meier) estimator, along with 95% confidence regions, from start of treatment.
Measured: At 24 months
ATM Status
Will be assessed by immunohistochemistry (IHC) and PFS. The association between ATM and responses will be described, with a table outlining patients who achieved progressive disease, stable disease, partial or complete responses and whether they exhibited ATM expression by IHC or not.
Measured: Up to 1 year post treatment
Peripheral Blood Mononuclear Cell gammaH2AX and p-ATM Signaling
Signaling during the pharmacokinetics (PK) lead-in and in combination with BAY 1895344 will be compared with a non-parametric paired test (e.g. Wilcoxon rank test), at a significance level at p < 0.05. For tumors, this will be performed only for patients in the dose expansion cohorts.
Measured: Up to 1 year post treatment
Tumor Multiplex Immunofluorescence Assay Signaling
Signaling during the PK lead-in and in combination with BAY 1895344 will be compared with a non-parametric paired test (e.g. Wilcoxon rank test), at a significance level at p < 0.05. For tumors, this will be performed only for patients in the dose expansion cohorts.
Measured: Up to 1 year post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2020
- Study start13 Aug 2021
- Primary completion19 Feb 2025
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Liza C Villaruz, Principal investigator, University of Pittsburgh Cancer Institute LAO
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04535401
- Sponsor's protocol ID
- NCI-2020-06482
- Other IDs
- NCI-2020-06482, 21-060, 10406, 10406, UM1CA186690
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2020
- Last updated
- 21 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.
Publications
Krishnamurthy A, Wang H, Rhee JC, Davar D, Moy RH, Ratner L, Christner SM, Holleran JL, Deppas J, Sclafani C, Schmitz JC, Gore S, Chu E, Bakkenist CJ, Beumer JH, Villaruz LC. Phase I trial of ATR inhibitor elimusertib with FOLFIRI in advanced or metastatic gastrointestinal malignancies (ETCTN 10406). Cancer Chemother Pharmacol. 2025 Jan 22;95(1):27. doi: 10.1007/s00280-024-04745-6.
PubMed 39841295