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Safety and Tolerability of DS-7423 in Subjects With Advanced Solid Malignant Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Tolerability of DS-7423 in Subjects With Advanced Solid Malignant Tumors

A Phase 1, Open-Label, Multiple-Escalating-Dose Study of DS-7423, an Orally Administered Dual PI3K/mTOR Inhibitor, in Subjects With Advanced Solid Tumors

NCT01364844•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

This will be a Phase 1, open-label study of DS-7423 to assess its safety and tolerability, identify a RP2D, (recommended Phase 2 Dose) and assess its Pharmacokinetics (PK) (what your body does to process the drugs and how your body gets them out of your system.) and pharmacodynamics (PDy) (Pharmacodynamics is a study of what a drug does to your body) properties in subjects with advanced solid malignant tumors. This study will include 2 parts: part 1-Dose Escalation and part 2-Dose Expansion. Study Hypothesis: DS-7423 will be safe and tolerable, and will exhibit acceptable PK and PDy properties in subjects with advanced solid malignant tumors for whom standard therapy has failed or for whom no standard therapy exists.

Detailed Description

Part 1 : Dose-escalation of DS-7423 to determine maximum tolerated dose (MTD) in subjects with advanced solid tumors Part 2 : Dose Expansion: The purpose of Part 2 of this clinical research study is to confirm the safety and tolerability of the MTD of DS-7423 identified in Part 1, and measure the effects of DS-7423 on your cancer. Part 2 will be conducted in subjects with advanced colorectal or endometrial cancer.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A pathologically documented advanced solid malignant tumor refractory to standard treatment or for which no standard treatment is available
•Eastern Cooperative Oncology Group (ECOG) performance status =\< 1
•Have adequate bone marrow function, defined as:
•Platelet count \>= 100 X 10\^9/L Hemoglobin (Hb) level \>= 9.0 g/dL ANC \>= 1.5 X 10\^9/L - Have adequate renal function, defined as: Creatinine clearance \>= 60 mL/min, as calculated using the modified Cockroft Gault equation, (\[{140 - age in yrs} x {actual weight in kg}\] divided by \[{72 x serum creatinine in mg/dL} multiply by 0.85 if female\]), or creatinine =\< 1.5 X ULN
•\- Have adequate hepatic function, defined as: AST/ALT levels =\< 3 X ULN (if liver metastases are present, =\< 5 X ULN) Bilirubin =\< 1.5 X ULN
•\- Have adequate blood clotting function, defined as: Prothrombin time and activated partial thromboplastin time =\< 1.5 X ULN
•Subjects should be able to provide written informed consent, comply with protocol visits and procedures, be able to take oral medication, and not have any active infection or chronic comorbidity that would interfere with therapy
•Subjects (male and female) of childbearing potential must agree to use double-barrier contraceptive measures or avoid intercourse during the study and for 90 days after the last dose of study drug
•Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects) and must sign and date an Institutional Review Board (IRB) approved informed consent form (ICF) (including Health Insurance Portability and Accountability Act (HIPAA) authorization, if applicable) before performance of any study-specific procedures or tests
•Subjects must be willing to provide available preexisting diagnostic or resected tumor samples, such as formalin-fixed paraffin-embedded sections. Providing fresh tumor biopsy is optional for subjects in dose escalation cohorts. Pre- and posttreatment biopsies are optional for all the subjects in Dose Escalation cohorts but required for those in Dose Expansion cohorts
+2 more criteria

Exclusion Criteria

•History of second malignancy and primary central nervous system malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ disease, or other solid tumors curatively treated, with no evidence of disease for \>= 3 years
•Gastrointestinal diseases that could affect the absorption of DS-7423
•Subjects with a fasting glucose \> 126 mg/dL (\> 7 mmol/L)
•History of diabetes mellitus (Type I or II) or hemoglobin A1c (HbA1c) \> 7.0%
•Tested positive for hepatitis B or C serological markers (HBsAg or antiHCV)
•Recipient of live vaccine within 1 month of or during study drug treatment
•Concomitant use of chronic systemic corticosteroids
•Subjects requiring daily supplemental oxygen
•Recipient of a stem cell or bone marrow transplant
•Has a concomitant medical condition that would increase the risk of toxicity, in the opinion of the investigator or sponsor
+11 more criteria

Locations (3)

Karmanos Cancer Institute

Detroit, Michigan, United States

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Key Dates

Start Date

July 1, 2011

Primary Completion Date

November 1, 2013

Completion Date

November 1, 2013

Last Updated

February 25, 2014

Enrollment

ACTUAL participants

Conditions

Solid TumorColorectal CancerEndometrial Cancer

Interventions

DS-7423

DRUG

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

NCT06898450

Advanced Solid Tumors CancerMSI-H Cancer

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RECRUITINGPHASE1

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

NCT04704661

Advanced Breast CarcinomaAdvanced Colon Carcinoma+38 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 25, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Safety and Tolerability of DS-7423 in Subjects With Advanced Solid Malignant Tumors

Inclusion Criteria

Exclusion Criteria

A Study to Assess the Safety, Tolerability, and Efficacy of NDI-219216 in Patients With Advanced Solid Tumors.

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

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Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

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