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As a leader in cancer research, Karmanos is able to offer patients access to innovative treatments and clinical trials that are often times not available anywhere else.
To offer hope and longer life to patients with all types of cancer, Karmanos offers the latest types of therapy through our clinical trials program. Through clinical trials, we are creating new knowledge about how therapies fight cancer and provide national leadership in testing these new therapies.
We understand that cancer is a complex disease that demands complex care. We provide each patient with a dynamic, carefully constructed treatment plan focused on their specific cancer and their unique needs.
We listen to you to design a plan that provides you with respect, compassionate care and is responsive to your emotional and practical concerns.
Phase I Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase II Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.
Phase III Includes trials conducted after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug.
Phase IV Studies of FDA-approved drugs to delineate additional information including thedrug's safety, benefits, or optimal use.
Phase Not Applicable Trials without phases (for example, studies of devices or behavioral interventions).
Results 1 - 9 of 9
Part A Dose Escalation
Part A1: KIN-2787 Monotherapy
• The primary objectives of Part A1 are to determine the safety and tolerability of oraladministration of KIN-2787 including DLTs in participants with BRAF mutation-positiveadvanced or metastatic solid tumors or melanoma harboring an NRAS mutation, and toidentify the MTD and/or the appropriate dose for further clinical investigation in Part BDose Expansion.• Secondary objectives include characterization of PK properties and effect of food on PKof KIN-2787.• Exploratory objectives include additional characterization of KIN-2787 PK, effect ofKIN-2787 on survival and other time-to-event endpoints, estimation of PD effects ofKIN-2787 in blood samples and tumor biopsies, assessment of both genotype andgenotypic changes under treatment to outcome.
Part A2: KIN-2787 Plus Binimetinib Combination
• The primary objectives of Part A2 are to determine the safety and tolerability of oraladministration of KIN-2787 + binimetinib including DLTs in participants with oncogenicBRAF mutation-positive advanced or metastatic solid tumors and melanoma harboringan NRAS mutation, and to identify the MTD and/or the appropriate dose for furtherclinical investigation.• The secondary objective is characterization of PK properties of KIN-2787 and binimetinibin combination.• Exploratory objectives include additional characterization of KIN-2787 PK, effect ofKIN-2787 on survival, and other time-to-event endpoints, estimation of PD effects ofKIN-2787 in blood samples and tumor biopsies, assessment of both genotype andgenotypic changes under treatment to outcome.
Part B: Dose Expansion
• The primary objective of the Part B Dose Expansion portion of the study is to assesspreliminary evidence of the anti-cancer activity of KIN-2787 in participants with advancedor metastatic solid cancers that harbor any oncogenic BRAF genomic alteration.• The secondary objective is to further evaluate the safety, tolerability, and the PKcharacteristics of KIN-2787 at the RP2D.• Exploratory objectives include additional characterization of KIN-2787 PK, effect ofKIN-2787 on survival and other time-to-event endpoints, estimation of PD effects ofKIN-2787 in blood samples and tumor biopsies, assessment of both genotype andgenotypic changes under treatment to outcome, evaluation of the PK of a new KIN-2787tablet formulation, impact on patient reported outcome (PRO) measures.
Part 1 Dose Escalation of SLC-3010 Monotherapy and in Combination
Primary Objectives:
Secondary Objectives:
Part 2: Dose Expansion of SLC-3010 Monotherapy and in Combination
Phase 1b part:
Phase 2 part:
Phase 1b part only:
Phase 1b and Phase 2 parts:
This pilot study will evaluate the use of [F-18] FLT and PET to measure tumor proliferation and the activity of thymidine kinase. This study may also assess the changes that occur after therapy. Finally we may compare the retention of [F-18] FLT in comparison to that of routine clinical measurements, such as CT, MRI or other imaging studies. One goal of this study is to better understand the abnormalities of thymidine metabolism in tumors in vivo. We may also compare imaging proliferation data using [F- 18] FLT to measurements of gene expression of proliferative and biochemical pathways made on tumor specimens obtained at biopsy.