A Phase 1/2 interventional study of Standard of Care chemotherapy Following an Algorithm and Standard of Care chemotherapy following CTCAE criteria in Solid Tumor Cancer, sponsored by Barbara Ann Karmanos Cancer Institute. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Barbara Ann Karmanos Cancer Institute · Phase 1/2, Interventional, and Treatment
The goal of this clinical trial is to:
Barbara Ann Karmanos Cancer Institute is the lead sponsor of 161 studies on the registry; 19 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 6 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participant must be diagnosed with or cytologically confirmed solid organ cancer and be treatment naive.
Exclusion Criteria:
Participants with active and uncontrolled bacterial, viral, or fungal infection requiring IV antibiotics.
Participants who have ever received cytotoxic chemotherapy.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
In phase 2, Patients with a positive Duffy-null blood test plus standard of care chemotherapy with dose adjustment according to an algorithm created in phase 1 of this study.
Drug: Standard of Care chemotherapy Following an Algorithm
In phase 2, patients with a negative Duffy-null blood test plus standard of care chemotherapy. Delays/modifications based on standard CTCAE (Common Terminology Criteria for Adverse Events) grading.
Drug: Standard of Care chemotherapy following CTCAE criteria
Standard of care chemotherapy for solid tumor malignancies with dose adjustment according to the algorithm produced in phase 1 for Duffy-null positive patients
Standard of care chemotherapy for solid tumor malignancies with dose modifications and delays according to the standard of care using CTCAE criteria.
The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI <85%
The proportion of patients with chemotherapy RDI (relative dose intensity) \<85% will be estimated separately for the Duffy-null and non-Duffy-null groups. The primary measure of interest is the absolute between-group difference in proportions. A one-sided 90% confidence interval (equivalently, a two-sided 80% confidence interval) will be constructed for this difference. Results will be interpreted relative to the prespecified clinically meaningful threshold of 15% to inform the go/no-go decision for Phase 2. Formal hypothesis testing will be conducted using a one-sided significance level of 10% based on Fisher's exact test.
Time frame: 5 months after the start of chemotherapy
The proportion of Duffy-null and non-Duffy-null participants who receive chemotherapy RDI (relative dose intensity) <85% after implementation of a new purposed algorithm from Phase 1.
The absolute difference in the proportion of patients with chemotherapy RDI \<85% between the Duffy-null group treated under the purposed dosing algorithm and the non-Duffy-null group treated under standard of care will be estimated. A non-inferiority analysis will be performed using a prespecified margin of 7.5%. A two-sided 80% confidence interval (equivalently, a one-sided 90% confidence interval) will be constructed, and non-inferiority will be concluded if the upper bound of the confidence interval is less than 7.5%.
Time frame: 5 months after the start of chemotherapy
Incidence rates of fever, infection, hospitalization, and treatment-related mortality in the first five months of chemotherapy treatment
Data will be collected at baseline and up until 4 months after the start of chemotherapy, as well as an additional one month in order to assess treatment-related neutropenia and risks associated with therapy. Incidence of neutropenic fever, infection, hospitalization, and treatment-related mortality within the first five months of chemotherapy will be summarized descriptively within each group. Incidence proportions and corresponding two-sided 95% confidence intervals will be reported. Longitudinal patterns of neutrophil counts will be compared between the Duffy-null and non-Duffy-null groups using appropriate longitudinal methods such as mixed-effects models. In addition, exploratory time-to-first-event analyses for neutropenic fever, infection, hospitalization, and treatment-related mortality may be conducted using Cox proportional hazards models adjusted for relevant confounders (e.g., age, cancer type), and will be considered supportive of the descriptive incidence summaries.
Time frame: 5 months after the start of chemotherapy
Proportion of chemotherapy dose delays or dose reductions attributed to neutropenia, as reported in the physician survey
The physician survey will be completed after each chemotherapy cycle where a dose delay or dose reduction occurs. This survey includes comments about dose changes and explaining the rationale for modifying treatment regimens. Physician survey data will be analyzed to address the exploratory objective of characterizing reasons for chemotherapy dose delays or dose reductions. Analyses will be conducted at the chemotherapy cycle level among cycles in which a dose delay or reduction occurred. The primary exploratory endpoint will be the proportion of treatment modifications attributed to neutropenia versus other reported reasons. These proportions will be summarized separately for Duffy-null and non-Duffy-null patients during Phase 1, with corresponding two-sided 95% confidence intervals. No formal hypothesis testing is planned for physician survey endpoints, and results will be interpreted as hypothesis-generating.
Time frame: 5 months after the start of chemotherapy
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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