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A Open-Label, Multiple Ascending Dose Study of DS-3078a, an Oral TORC1/2 Kinase Inhibitor, in Subjects With Advanced Solid Tumors or Lymphomas | Clinical Trials | Clareo Health

COMPLETEDPHASE1

A Open-Label, Multiple Ascending Dose Study of DS-3078a, an Oral TORC1/2 Kinase Inhibitor, in Subjects With Advanced Solid Tumors or Lymphomas

A Phase 1, Open-Label, Multiple Ascending Dose Study of DS-3078a, an Oral TORC1/2 Kinase Inhibitor, in Subjects With Advanced Solid Tumors or Lymphomas

NCT01588678•Daiichi Sankyo

View on ClinicalTrials.gov

Summary

DS-3078a will be evaluated as a single agent in subjects with advanced solid tumor malignancies or lymphomas refractory to standard treatment or for which no standard treatment is available.

Detailed Description

This is a Phase 1, open-label study of DS-3078a to assess safety and tolerability, identify the maximum tolerated dose (MTD) and tentative recommended phase 2 dose (RP2D), and assess pharmacokinetic and pharmacodynamic properties in subjects with advanced solid tumor malignancies or lymphomas. The study will include 2 parts: Dose Escalation and Dose Expansion.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A pathologically or cytologically documented advanced solid tumor or lymphoma that has relapsed from or is refractory to standard treatment or for which no standard treatment is available.
•Men or women \>=18 years old.
•Eastern Cooperative Oncology Group (ECOG) performance status =\<1
•Have adequate bone marrow function, defined as:
•* Platelet count \>=100 x 10\^9/L for solid tumors and \>=75 x 10\^9/L for lymphomas,
•* Hemoglobin level \>=9.0 g/dL, and ANC \>=1.5 x 10\^9/L for solid tumors and \>=1.0 x 10\^9/L for lymphomas.
•Have adequate renal function, defined as:
•Creatinine clearance \>=60 mL/min, or creatinine =\<1.5 x ULN.
•Have adequate hepatic function, defined as:
•* AST/ALT levels =\<3 x ULN (=\<5 x ULN if liver metastases are present) and
+6 more criteria

Exclusion Criteria

•History of primary central nervous system malignancies
•Gastrointestinal diseases that could affect the absorption of DS-3078a in the opinion of the Investigator
•Subjects with a fasting glucose \>126 mg/dL (\>7 mmol/L)
•History of diabetes mellitus (type 1 or 2) or glycosylated hemoglobin \>7.0% at screening
•Positive test for hepatitis B surface antigen or hepatitis C antibody
•Recipient of live vaccine within 1 month of or during study drug treatment
•Use of chronic systemic corticosteroids (use of nasal or inhaled steroids is permitted)
•Subjects requiring daily supplemental oxygen
•Recipient of an allogenic stem cell or bone marrow transplant
•Presence of a concomitant medical condition that would increase the risk of toxicity, in the opinion of the Investigator or Sponsor
+12 more criteria

Locations (1)

South Texas Accelerated Research Therapeutics

San Antonio, Texas, United States

Key Dates

Start Date

April 1, 2012

Primary Completion Date

June 1, 2014

Completion Date

June 1, 2014

Last Updated

February 12, 2019

Enrollment

ACTUAL participants

Conditions

Advanced Solid TumorLymphoma

Interventions

DS-3078a

DRUG

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

NCT05139017

DLBCLDiffuse Large B-Cell Lymphoma

View study

RECRUITINGPHASE2

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

NCT05529069

Mantle Cell LymphomaNon Hodgkin Lymphoma+1 more

View study

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 12, 2019Data 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

A Open-Label, Multiple Ascending Dose Study of DS-3078a, an Oral TORC1/2 Kinase Inhibitor, in Subjects With Advanced Solid Tumors or Lymphomas

Inclusion Criteria

Exclusion Criteria

A Study of Zilovertamab Vedotin (MK-2140) in Combination With Standard of Care in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (rrDLBCL) (MK-2140-003)

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

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

Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma

A Study of PYX-201 in Advanced Solid Tumors