Clinical Trials Actively Recruiting

Having a large clinical trial portfolio means giving patients treatment options often not available anywhere else, and years before they become the standard of care. To learn more about Karmanos Cancer Institute clinical trials or to see if a trial is right for you, please call 1-800-KARMANOS (1-800-527-6266) or request an appointment below.

Results 1 - 10 of 30

  • Objective:
    Primary Objective(s):
    • To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy.
    Secondary Objective(s):
    • To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of predefined subsequent cardiac events in patients with metastatic breast cancer receiving trastuzumab?based HER-2 targeted therapy.
    • To evaluate if prophylactic carvedilol compared with no intervention results in a longer time to first interruption of trastuzumab?based HER-2 targeted therapy due to either cardiac dysfunction or events.
    • To assess whether prophylactic beta blocker therapy with carvedilol compared with no intervention reduces the risk of subsequent cardiac dysfunction OR events in this population.
    • To establish and prospectively collect a predefined panel of baseline core cardiovascular measures and develop a predictive model of cardiac dysfunction (see Section 11.2).
    • To evaluate the rate of cardiac dysfunction in an observational arm consisting of individuals otherwise eligible for the study except for use of beta blockers, angiotensin receptor blocker (ARB), or angiotensin converting enzyme (ACE) inhibitors for other medical reasons.
    Cancer Categories:
    • Breast
    Principal Investigator:
    • Assad, Hadeel
    Karmanos Trial ID:
    • S1501
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:
    Primary Objective:
    • To determine if 3year recurrence-free survival (RFS) is greater than 92% among clinical stages II or IIIa patients with HER2positive breast cancer who achieve pCR (ypT0/is ypN0) after preoperative therapy with 12 weeks of a taxane, trastuzumab (or FDA approved biosimilar) and pertuzumab (THP x 12). Post-operatively, patients will receive standard of care adjuvant locoregional therapy, plus completion of 12 months of HER2targeted therapy (and standard adjuvant endocrine therapy as appropriate).
    Secondary Objectives:

    Secondary Clinical Objectives
    • To determine 3year IDFS (invasive disease-free survival), DDFS (distant disease-free survival), DRFS (distant relapse-free survival), RFI (recurrence-free interval), OS (overall survival) and Breast Cancer-specific Survival in patients who achieve pCR (and by pre-treatment clinical stage).
    • To determine 3year EFS (event-free survival) in all patients from time of study registration.
    • To evaluate safety and tolerability for all patients during the preoperative phase and for patients who attain pCR and deescalate therapy (Arm A) until the completion of post-surgery protocol assigned therapy (i.e. until the end of HP therapy).
    Secondary Correlative Objectives
    • To evaluate the association of ER status in the untreated primary tumor with pathologic response and with long term survival outcomes (including RFS, EFS, IDFS, DDFS, DRFS, RFI, OS, and Breast Cancer-specific Survival).
    • To evaluate the associations of detection of CTCs in the blood at baseline with pCR.
    • To evaluate the association of detection of CTCs in the blood at baseline, after 3 weeks of THP, after 12 weeks of THP (before surgery), after surgery before any additional therapy, and after completion of HER2targeted therapy with RFS in patients who achieve pCR or not.
    Cancer Categories:
    • Breast
    Principal Investigator:
    • Elayoubi, Jailan
    Karmanos Trial ID:
    • EA1181
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objective:

    • Evaluate the performance of FDG-PET/CT response criteria (modified PERCIST complete, partial and stable metabolic disease versus progressive metabolic disease) as a binary predictor of PFS in patients with BD MBC treated with systemic therapy.

    Secondary Objectives:

    • Evaluate the ability of FDG-PET/CT modified PERCIST criteria (complete vs partial vs stable vs metabolic progression) to independently predict PFS in patients with BD MBC.
    • Evaluate the ability of FDG-PET/CT modified PERCIST criteria (complete, partial, and stable versus progressive metabolic disease) to predict time to SRE and OS in patients with BD MBC.
    • Evaluate the ability of FDG-PET/CT metrics (percent change in SULpeak, SUVmax as continuous variables in index or up to 5 lesions) to predict PFS, time to SRE and OS in patients with BD MBC.
    • Assess the utility of FDG-PET/CT to identify disease progression by identification of new lesions not identified by standard CT and bone scan.
    Cancer Categories:
    • Breast
    Principal Investigator:
    • Assad, Hadeel
    Karmanos Trial ID:
    • EA1183
    Age Group:
    • Adult
    Phase:
    • NA
  • Objective:

    Primary Objective:

    • To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an "advanced" breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). For purposes of this study, "advanced" cancers are those meeting any of the following criteria at any time during a period of 4.5 years from randomization:
      • there are distant metastases,
      • there are positive lymph nodes*,
      • the cancer is invasive and is greater than or equal to 20 mm in size, or
      • the cancer is invasive and is greater than 10 mm and less than 20 mm in size and is either: 1) ER- and PR- and HER2-, or is 2) HER2+.

    *lymph nodes with micrometastases (none greater than 2 mm) and/or isolated tumor cells are not considered lymph node positive for definition of advanced cancer. All cancers that meet these criteria that present within 4.5 years of randomization will be counted in the primary endpoint.

    Secondary Objectives:

    • To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms.
    Cancer Categories:
    • Breast
    Principal Investigator:
    • Choromanska, Agnieszka
    Karmanos Trial ID:
    • EA1151
    Age Group:
    • Adult
    Phase:
    • Phase II
  • Objective:

    Primary Objectives:

    • Determine the maximum tolerated dose (MTD) of CB-03-10 in subjects with advanced solid tumors
    • Determine the dose-limiting toxicity (DLT) of CB-03-10 in subjects with advanced solid tumors

    Secondary Objectives:

    • Determine a recommended Phase 2 dose (RP2D) of CB-03-10
    • Determine the safety profile of CB-03-10 in subjects with advanced solid tumors
    • Evaluate the activity (response rate, PFS, and OS) of CB-03-10 in subjects with specific solid tumors (e.g., relapsed/refractory pancreatic adenocarcinoma, androgen independent prostate adenocarcinoma, relapsed/refractory triple-negative breast adenocarcinoma)
    • Characterize the pharmacokinetics (PK) of CB-03-10 and its metabolite CB-03-05 as well as cortexolone in plasma and urine.
    Cancer Categories:
    • Brain and Nervous System,Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Other,Sarcoma,Skin
    Principal Investigator:
    • Winer, Ira
    Karmanos Trial ID:
    • 2022-036
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objectives:

    Phase 1

    • Assess safety and tolerability of NUV-868 as monotherapy and determine the recommended phase 2 dose (RP2D) for monotherapy treatment

    Phase 1b

    • Assess safety and tolerability of NUV-868 as combination therapy and determine the recommended phase 2 combination dose (RP2cD) for each combination treatment
    • Evaluate the potential drug interaction between NUV-868 and olaparib
    • Evaluate the potential drug interaction between NUV-868 and enzalutamide

    Phase 2

    • Evaluate efficacy of NUV-868 as monotherapy

    Phase 2b

    • Evaluate efficacy of NUV-868 as combination therapy

    Secondary Objectives:

    Phase 1

    • Explore preliminary efficacy of NUV-868 as monotherapy
    • Characterize the PK profile of NUV-868
    • Characterize the effect of food on the PK profile of NUV-868

    Phase 1b

    • Explore preliminary efficacy of NUV-868 as combination treatment

    Phase 2

    • Further evaluate efficacy of NUV-868 as monotherapy

    Phase 2b

    • Further evaluate efficacy of NUV-868 as combination therapy

    Phase 2 and Phase 2b

    • Evaluate drug exposure response relationship

    Phase 1, 1b, 2 and Phase 2b

    • Further evaluate safety
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic
    Principal Investigator:
    • Shields, Anthony
    Karmanos Trial ID:
    • 2022-026
    Age Group:
    • Adult
    Phase:
    • Phase I/II
  • Objective:

    Primary objective:

    • To determine if the iDFS with T-DM1 and tucatinib is superior to the iDFS in the control arm (T-DM1 + placebo) when administered to high risk patients with HER2-positive breast cancer and residual disease after neoadjuvant HER2-directed therapy.

    Secondary objectives:

    • To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with TDM1 alone (T-DM1 plus placebo) improves the following:
      • overall survival (OS)
      • breast cancer free survival (BCFS)
      • distant recurrence-free survival (DRFS)
      • disease-free survival (DFS)
      • brain metastases-free survival (BMFS).
    • To evaluate whether treatment with tucatinib plus T-DM1 compared to treatment with TDM1 alone (T-DM1 plus placebo) reduces the incidence of brain metastases.
    Cancer Categories:
    • Breast
    Principal Investigator:
    • Elayoubi, Jailan
    Karmanos Trial ID:
    • A011801
    Age Group:
    • Adult
    Phase:
    • Phase III
  • Objective:

    Primary Objective:

    • to establish the maximum tolerated dose (MTD) and evaluate the safety and tolerability of HC-5404-FU when orally administered in a dose-escalating fashion in subjects with advanced solid tumors.

    Secondary Objectives:

    • to determine the plasma concentrations and pharmacokinetic (PK) parameters of HC-5404 following single and multiple doses of HC-5404 administered to subjects with advanced solid tumors
    • to preliminarily assess the potential antitumor activity of HC-5404-FU in terms of response rates and survival outcomes.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Genitourinary (GU),Lung
    Principal Investigator:
    • Uprety, Dipesh
    Karmanos Trial ID:
    • 2022-004
    Age Group:
    • Adult
    Phase:
    • Phase I
  • Objective:

    Primary Objective:

    • The primary objective of this pilot study is to evaluate tracer uptake and metabolic trapping characteristics based on [18F]FETrp PET/CT in patients with intra- and extracranial cancers; specifically, to evaluate whether the tumors show increased tracer uptake as measured by both tumor maximal and mean standardized uptake value (SUVmax and SUVmean, respectively), as compared to non-tumor tissues. In the special case of breast tumor imaging, the primary objective will be the correlation between the tumors’ SUV values and the apparent volume of distribution (VD’) which will be calculated using kinetic modeling analysis.

    Secondary Objectives:

    • Using dynamic PET imaging to establish the optimal time frame when tracer uptake peaks.
    • Using compartmental modeling (in tumors with the left ventricle of the heart in the field-of-view) to measure tracer transport and trapping variables.
    • To obtain first in human safety, biodistribution, and radiation dosimetry data for [18F]FETrp PET/CT.
    Cancer Categories:
    • Brain and Nervous System,Breast,Genitourinary (GU)
    Principal Investigator:
    • Juhasz, Csaba
    Karmanos Trial ID:
    • 2022-010
    Age Group:
    • Adult
    Phase:
    • NA
  • Objective:

    Primary Objectives:

    • To evaluate the safety and tolerability of SGN1 in patients with advanced solid tumor.

    Secondary Objectives:

    • To make a preliminary determination of the Maximum Tolerated Dose (MTD) and optimal biological dose (OBD).
    • To evaluate blood and urine levels of SGN1.
    • To evaluate bacterial shedding of SGN1.
    • To evaluate the anti-tumor effect of SGN1 in the treatment of patients with advanced solid tumor.
    • To evaluate additional safety measures.
    Cancer Categories:
    • Breast,Gastrointestinal (GI),Gynecologic,Head and Neck,Lung,Skin
    Principal Investigator:
    • Uprety, Dipesh
    Karmanos Trial ID:
    • 2021-073
    Age Group:
    • Adult
    Phase:
    • Phase I