Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study of TAS0612 in Participants With Advanced or Metastatic Solid Tumor Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586270
Recruitment Status : Recruiting
First Posted : October 14, 2020
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Taiho Oncology, Inc.

Brief Summary:
The purpose of this study is to see if TAS0612 is safe in participants with advanced or metastatic solid tumor cancer.

Condition or disease Intervention/treatment Phase
Advanced or Metastatic Solid Tumors Drug: TAS0612 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of TAS0612 in Patients With Locally Advanced or Metastatic Solid Tumors
Actual Study Start Date : October 15, 2020
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: TAS0612 Escalation
TAS0612 administered orally
Drug: TAS0612
oral tablets

Experimental: TAS0612 Expansion
TAS0612 administered orally
Drug: TAS0612
oral tablets




Primary Outcome Measures :
  1. Dose Limiting Toxicities (DLTs) [ Time Frame: Baseline through Cycle 1 (28 day cycle) ]
    Number of participants with DLTs during cycle 1

  2. Objective Response Rate [ Time Frame: Baseline through measured progressive disease (estimated up to 24 months) ]
    Percentage of participants with partial response (PR) or complete response (CR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.


Secondary Outcome Measures :
  1. Disease Control Rate (DCR) [ Time Frame: Baseline through progressive disease (estimated up to 24 months) ]
    DCR: Percentage of participants who exhibit stable disease (SD), PR or CR.

  2. Duration of Response (DOR) [ Time Frame: Estimated up to 22 months ]
    DOR: Date of PR or CR to date of objective progression or death due to any cause.

  3. Progression Free Survival (PFS) [ Time Frame: Estimated up to 24 months ]
    Baseline to objective progression or death due to any cause.

  4. Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]
    Cmax of TAS0612

  5. Pharmacokinetics (PK): plasma concentration of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]
    Plasma concentration of TAS0612

  6. PK: Area under the plasma concentration curve (AUC) [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]
    AUC of TAS0612

  7. PK: Time it takes to reach Cmax (Tmax) of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]
    Tmax of TAS0612

  8. PK: Time it takes for plasma concentration to fall by half its original value (t1/2) of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28 day cycle) ]
    t1/2 of TAS0612

  9. Safety and Tolerability [ Time Frame: Estimated up to 24 months ]
    All adverse events (AEs) per CTCAE v5.0

  10. Pharmacodynamic: biochemical effects of TAS0612 [ Time Frame: Cycle 1 Day 1 through Cycle 1 Day 15 (28-day cycle) ]
    Total proteins and phospho-proteins will be measured in blood samples collected at different time points. The levels/changes (dose- and concentration-dependent) of phospho-proteins will be assessed and reported for biochemical effects of TAS0612.

  11. Pharmacodynamic: molecular effects in tumor tissue of TAS0612 [ Time Frame: Baseline through Day 1 Cycle 2 (28-day cycle) ]
    Selected phospho-proteins will be analyzed in tumor tissue at baseline and on-treatment in dose escalation. The levels/changes of the phospho-proteins will be assessed and reported for target modulation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Dose Escalation: have evidence of a solid tumor that is locally advanced and/or metastatic (excluding primary brain tumor)
  • Dose Expansion: have evidence of a solid tumor as outlined below that is locally advanced and/or metastatic (excluding primary brain tumor)

    • Cohort A: Human epidermal growth factor negative (HER2 negative) Breast Cancer with an NF1 mutation
    • Cohort B: Hormone receptor positive (HR+)/HER2 negative breast cancer after progression on endocrine therapy and a CDK4/6 inhibitor
    • Cohort C: PTEN loss or mutations
    • Cohort D: KRAS G12C mutation
    • Cohort E: KRAS G12D mutation
  • Have adequate organ function
  • Amenable to biopsy
  • Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Exclusion Criteria:

  • Participating in medical research not compatible with this study
  • Have not discontinued or recovered from previous treatments for cancer
  • Have a significant cardiac condition
  • Have untreated brain metastases
  • Have a primary brain tumor
  • Have a serious concomitant disorder
  • Unable to swallow or digest pills
  • Poorly controlled diabetes
  • Concomitant medications or substances that are strong inhibitors/inducers of CYP3A.Study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586270


Contacts
Layout table for location contacts
Contact: Jill Kremer, MD 609-250-7336 clinicaltrialinfo@taihooncology.com

Locations
Layout table for location information
United States, Tennessee
Tennessee Oncology Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
France
Centre de Lutte Contre le Cancer Gustave Roussy Recruiting
Villejuif, Cedex, France, 94805
Sponsors and Collaborators
Taiho Oncology, Inc.
Layout table for additonal information
Responsible Party: Taiho Oncology, Inc.
ClinicalTrials.gov Identifier: NCT04586270    
Other Study ID Numbers: TAS0612-101
2020-002304-39 ( EudraCT Number )
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taiho Oncology, Inc.:
Solid Tumors
AKT inhibitor
RSK inhibitor
S6K inhibitor
kinase inhibitor
phase I
phase 1
NF1 mutation
endocrine therapy resistance
PTEN loss
PTEN mutation
KRAS G12C
KRAS G12D
breast cancer
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms