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

  • STATUS
    Recruiting
  • End date
    Jun 18, 2024
  • participants needed
    120
  • sponsor
    Deciphera Pharmaceuticals LLC
Updated on 18 June 2021
measurable disease
solid tumor
solid neoplasm

Summary

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.

Details
Condition Pigmented villonodular synovitis, Advanced Cancer, Advanced Malignant Neoplasm, Tenosynovial Giant Cell Tumor, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Giant Cell Tumor of Tendon Sheath, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, cancer advanced, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse, Tenosynovial Giant Cell Tumor, Diffuse
Treatment DCC-3014
Clinical Study IdentifierNCT03069469
SponsorDeciphera Pharmaceuticals LLC
Last Modified on18 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Dose Escalation Phase
Patients 18 years of age
Patients must have
advanced malignant solid tumors; or
symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
Malignant solid tumor patients only: Able to provide a tumor tissue sample
Must have 1 measurable lesion according to RECIST Version 1.1
Malignant solid tumor patients only: Must have ECOG performance status of 0-1
Adequate organ and bone marrow function
If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements
Must provide signed consent to participate in the study and is willing to comply with study-specific procedures
Expansion Phase (Cohorts A and B)
Patients 18 years of age
Patients must have symptomatic TGCT for which surgical resection is not an option (tumor biopsy to confirm diagnosis required if no histology/pathology available at screening)
Expansion Cohort B: patients must have prior systemic treatment with anti-CSF1 or anti-CSF1R therapy, with the exception of imatinib or nilotinib
Adequate organ and bone marrow function
Must have at least 1 measurable lesion according to RECIST Version 1.1
If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements
Must provide signed consent to participate in the study and is willing to comply with study-specific procedures

Exclusion Criteria

Dose Escalation Phase
Received anticancer therapy or therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with half-life (t1/2) longer than 3 days prior to the administration of study drug
Unresolved toxicity (Grade >1 or baseline) from previous anticancer therapy or TGCT therapy, excluding alopecia
Known active CNS metastases
History or presence of clinically relevant cardiovascular abnormalities
Systemic arterial or venous thrombotic or embolic events
QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome
Left ventricular ejection fraction (LVEF) <50%
Concurrent treatment with proton-pump inhibitor(s)
Major surgery within 2 weeks of the first dose of study drug
Malabsorption syndrome or other illness that could affect oral absorption
Known human immunodeficiency virus, active hepatitis B, active hepatitis C, or active mycobacterium tuberculosis infection
If female, the patient is pregnant or lactating
Known allergy or hypersensitivity to any component of the study drug
Any other clinically significant comorbidities
Expansion Phase (Cohorts A and B)
Expansion Cohort A: received systemic therapy targeting CSF1 or CSF1R; previous therapy with imatinib and nilotinib is allowed
Expansion Cohort B: discontinued systemic therapy targeting anti-CSF1 or anti-CSF1R due to drug-induced liver injury
Treatment with therapy for TGCT, including investigational therapy, within 2 weeks or 28 days for therapies with a t1/2 longer than 3 days prior to the administration of the study drug
Known metastatic TGCT or other active cancer that requires concurrent treatment
QT interval corrected by Fridericia's formula (QTcF) >450 ms in males or >470 ms in females or history of long QT syndrome
Left ventricular ejection fraction (LVEF) <55%
Concurrent treatment with proton-pump inhibitor(s)
Major surgery within 2 weeks of the first dose of study drug
Any clinically significant comorbidities
Malabsorption syndrome or other illness that could affect oral absorption
Known human immunodeficiency virus (HIV), active or chronic hepatitis B, active or chronic hepatitis C, or active mycobacterium tuberculosis infection
If female, the patient is pregnant or lactating
Known allergy or hypersensitivity to any component of the study drug
Contraindication for MRI
Active liver or biliary disease, including evidence of fatty liver, nonalcoholic steatohepatitis (NASH), or cirrhosis
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