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Study of DCC-3014 in Patients With Advanced Tumors

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: NCT03069469
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Deciphera Pharmaceuticals LLC

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Advanced Malignant Neoplasm Tenosynovial Giant Cell Tumor, Diffuse Drug: DCC-3014 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 16, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental Treatment

Escalation 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.

Drug: DCC-3014
CSF1R inhibitor




Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: Day 1 - Day 28 of Cycle 1 for each dose level tested ]
    Identify the dose limiting toxicities for each dose level tested and determine the maximum tolerated dose and recommended phase 2 dose

  2. Incidence of Adverse Events [ Time Frame: Cycle 1 through study completion (~ 24 months) ]
    Identify the observed adverse events, serious adverse events associated with DCC-3014

  3. Time to maximum observed concentration of DCC-3014 [ Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 through study completion (~24 months) at the following time points: pre-dose and 1, 2, 4, 6, 8 hours post-dose ]
    Measure the time to maximum plasma concentration of DCC-3014 in patients

  4. Maximum observed concentration of DCC-3014 [ Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 through study completion (~24 months) at the following time points: pre-dose and 1, 2, 4, 6, 8 hours post-dose ]
    Measure the maximum observed concentration of DCC-3014 in patients

  5. Trough observed concentration of DCC-3014 [ Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 through study completion (~24 months) at the following time points: pre-dose and 1, 2, 4, 6, 8 hours post-dose ]
    Measure the observed trough concentration of DCC-3014 in patients

  6. Area under the concentration-time curve of DCC-3014 [ Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 through study completion (~24 months) at the following time points: pre-dose and 1, 2, 4, 6, 8 hours post-dose ]
    Measure the AUC of DCC-3014

  7. Half life of DCC-3014 [ Time Frame: Cycle 1 Day 1 and Day 8, and Cycle 2 Day 1 through study completion (~24 months) at the following time points: pre-dose and 1, 2, 4, 6, 8 hours post-dose ]
    Measure the half life of DCC-3014 in patients

  8. Objective response rate (ORR= complete response [CR]+partial response [PR]) (Diffuse type Tenosynovial Giant Cell Tumor [DTGCT] patients Expansion phase only) [ Time Frame: Baseline through 24 months ]
    Assessed by central read using RECIST Version 1.1

  9. Duration of response rate (DOR) (DTGCT patients Expansion phase only) Measure time from PR or CR to disease progression or death) [ Time Frame: Baseline through 24 months ]
    Measure time from PR or CR to disease progression or death


Secondary Outcome Measures :
  1. Response rate [ Time Frame: Baseline through 24 months ]
    Assessed by central read using tumor volume score (DTGCT patients Expansion Phase only)

  2. Range of Motion (ROM) [ Time Frame: Baseline through 24 months ]
    Measure mean change from baseline in relative ROM (DTGCT patients Expansion Phase only)

  3. Patient reported outcomes [ Time Frame: Approximately 12 months ]
    Analysis of PRO based upon the Patient-reported outcomes measurement information system (PROMIS) physical function questionnaire (DTGCT patients Expansion Phase only)



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.


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

Inclusion Criteria:

  1. Patients ≥18 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, therapy for DTGCT, 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.

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): NCT03069469


Contacts
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Contact: Study Director 785-830-2100 clinicaltrials@deciphera.com

Locations
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United States, California
Stanford Cancer Institute Recruiting
Palo Alto, California, United States, 94304
Contact: Kristin Ganjoo, MD         
United States, Colorado
University of Colorado - Denver Recruiting
Denver, Colorado, United States, 80204
Contact: Stephen Leong, MD         
United States, Florida
Mayo Clinic Not yet recruiting
Jacksonville, Florida, United States, 32224
Contact: Steven Attia         
United States, New York
MSKCC Not yet recruiting
New York, New York, United States, 10065
Contact: William Tap, MD         
United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Jacqueline Vuky, MD         
United States, Tennessee
Sarah Cannon Research Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Todd Bauer, MD         
Principal Investigator: Todd Bauer, MD         
Canada
Princess Margaret Cancer Center Recruiting
Toronto, Canada
Contact: Albiruni Razak         
Sponsors and Collaborators
Deciphera Pharmaceuticals LLC
Investigators
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Study Director: Rodrigo Ruiz Soto, MD Deciphera Pharmaceuticals LLC

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Responsible Party: Deciphera Pharmaceuticals LLC
ClinicalTrials.gov Identifier: NCT03069469    
Other Study ID Numbers: DCC-3014-01-001
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deciphera Pharmaceuticals LLC:
CSF1R
Breast cancer
Prostate cancer
NSCLC
DTGCT
PVNS
Additional relevant MeSH terms:
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Giant Cell Tumors
Giant Cell Tumor of Tendon Sheath
Synovitis, Pigmented Villonodular
Neoplasms
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Synovitis
Joint Diseases
Musculoskeletal Diseases
Tendinopathy
Muscular Diseases