Clinical Trials /

Study of DCC-3014 in Patients With Advanced Tumors and Tenosynovial Giant Cell Tumor

NCT03069469

Description:

This is a multicenter, open-label Phase 1/2 study of DCC-3014 in patients with malignant solid tumors and tenosynovial giant cell tumor (TGCT). There will be 2 distinct parts in this study: Dose Escalation (Phase 1) and Expansion (Phase 2). Phase 1 will enroll both malignant solid tumor and TGCT patients. Phase 2 will comprise two cohorts (Cohort A and Cohort B) and will only enroll TGCT patients.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Study of DCC-3014 in Patients With Advanced Tumors
  • Official Title: Multi-center, Phase 1, Open-Label Study of DCC-3014 to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Patients With Advanced Tumors

Clinical Trial IDs

  • ORG STUDY ID: DCC-3014-01-001
  • NCT ID: NCT03069469

Conditions

  • Advanced Malignant Neoplasm
  • Tenosynovial Giant Cell Tumor, Diffuse

Interventions

DrugSynonymsArms
DCC-3014Experimental Treatment

Purpose

This is a multicenter, open-label Phase 1 study of DCC-3014 in patients with advanced solid tumors including but not limited to prostate, breast, gastric, ovarian, and non-small cell lung cancer as well as tumor types with high macrophage content or high expression of CSF-1 such as diffuse-type tenosynovial giant cell tumor. There will be an Escalation Phase and an Expansion Phase in this study

Trial Arms

NameTypeDescriptionInterventions
Experimental TreatmentOtherEscalation Phase: Increasing doses of DCC-3014 beginning at 10 mg QD for 28 day cycles until disease progression or unacceptable toxicity. Expansion Phase: Dosing of different patient cohorts at the dose level determined from the escalation phase of the study.
  • DCC-3014

Eligibility Criteria

        Inclusion Criteria:

          1. Patients ≥18 years of age

               -  Diffuse-type Tenosynovial Giant Cell Tumor (DTGCT) patients: ≥16 years of age

          2. Patients must have advanced solid tumors or symptomatic DTGCT for which surgical
             resection is not an option

          3. Able to provide a tumor tissue sample

          4. Must have 1 measurable lesion according to RECIST Version 1.1

          5. Must have ECOG performance status of 0-1

          6. Adequate organ and bone marrow function

          7. If a female of childbearing potential, must have a negative pregnancy test prior to
             enrollment.

          8. Must provide signed consent to participate in the study and is willing to comply with
             study-specific procedures.

        Exclusion Criteria:

          1. Received anticancer therapy, including investigational therapy, within 2 weeks or 28
             days for therapies with half-life longer than 3 days prior to the administration of
             study drug.

          2. Unresolved toxicity (>Grade 1 or baseline) from previous anticancer therapy, excluding
             alopecia.

          3. Known active CNS metastases.

          4. History or presence of clinically relevant cardiovascular abnormalities.

          5. Systemic arterial or venous thrombotic or embolic events.

          6. QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in
             females or history of long QT syndrome.

          7. Left ventricular ejection fraction (LVEF) <50%.

          8. Concurrent treatment with proton-pump inhibitor.

          9. Major surgery within 2 weeks of the first dose of study drug.

         10. Malabsorption syndrome or other illness that could affect oral absorption.

         11. Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active
             mycobacterium tuberculosis infection.

         12. If female, the patient is pregnant or lactating.

         13. Known allergy or hypersensitivity to any component of the study drug.

         14. Any other clinically significant comorbidities.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:16 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose
Time Frame:Day 1 - Day 28 of Cycle 1 for each dose level tested
Safety Issue:
Description:Identify the dose limiting toxicities for each dose level tested and determine the maximum tolerated dose and recommended phase 2 dose

Secondary Outcome Measures

Measure:Levels of CSF1R-dependent myeloid cells
Time Frame:Day 1 Cycle 1 through study completion (~24 months)
Safety Issue:
Description:Measure the amount of CSF1R-dependent myeloid cells in patients
Measure:Levels of CSF-1 in plasma
Time Frame:Day 1 Cycle 1 through study completion (~24 months)
Safety Issue:
Description:Measure the levels of CSF-1 in plasma
Measure:Abundance of tumor-associated macrophages
Time Frame:Day 1 Cycle 1 through study completion (~24 months)
Safety Issue:
Description:Measure of the number of tumor-associated macrophages found in the tumor tissue
Measure:Localization of tumor-associated macrophages
Time Frame:Day 1 Cycle 1 through study completion (~24 months)
Safety Issue:
Description:Measure of the distribution of tumor-associated macrophages within the tumor tissue relevant to tumor cells
Measure:Objective response rate (ORR)
Time Frame:Approximately 24 months
Safety Issue:
Description:Evaluate objective response rate as determined by confirmed complete response (CR) + partial response (PR)

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Deciphera Pharmaceuticals LLC

Trial Keywords

  • CSF1R
  • Breast cancer
  • Prostate cancer
  • NSCLC
  • DTGCT
  • PVNS

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