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A Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma

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ClinicalTrials.gov Identifier: NCT02975700
Recruitment Status : Active, not recruiting
First Posted : November 29, 2016
Last Update Posted : December 20, 2017
Sponsor:
Collaborator:
Daiichi Sankyo, Inc.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. )

Brief Summary:
The purpose of this Phase I/II study is to evaluate safety, pharmacokinetics, and preliminary efficacy of the investigational drug PLX3397 in subjects with unresectable or metastatic KIT-mutated melanoma.

Condition or disease Intervention/treatment Phase
Melanoma Drug: PLX3397 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I/II Open Label, Multicenter Study of PLX3397 in Patients With Unresectable or Metastatic KIT-mutated Melanoma
Study Start Date : January 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: PLX3397

Part 1: Open label, multicenter study includes a dose evaluation portion in which the safety profile of PLX3397 as a single oral agent will be evaluated

Part 2: An expansion cohort in which the efficacy and safety of PLX3397 administered at the recommended Phase 2 dose will be evaluated in patients with unresectable stage III or stage IV KIT-mutated melanoma.

Drug: PLX3397
Other Name: Pexidartinib




Primary Outcome Measures :
  1. Number of participants with dose-limiting toxicities [Part 1] [ Time Frame: 1 year ]
    This measure is used to determine the recommended Part 2 Dose (R2PD)

  2. Area under the concentration-time curve (AUC) of PLX3397 [Part 1] [ Time Frame: 1 year ]
  3. Maximum observed concentration (Cmax) of PLX3397 [Part 1] [ Time Frame: 1 year ]
  4. Time to peak concentration (Tmax) of PLX3397 [Part 1] [ Time Frame: 1 year ]
  5. Number of participants achieving objective response [Part 2] [ Time Frame: 1 year ]
    Objective response is the sum of complete response (CR) and partial response (PR) by RECIST 1.1 criteria

  6. Number of participants with serious and non-serious adverse events (AEs) by the end of Part 1 [ Time Frame: by the end of Part 1 (1 year) ]

    An AE can be any unfavorable and unintended sign (e.g., including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not it is considered to be study drug related. This includes any newly occurring event or previous condition that has increased in severity or frequency since the administration of study drug.

    SAEs are events that pose a threat to a patient's life or functioning. Clear progression of the underlying cancer and hospitalizations due to the progression of cancer should not be reported as an adverse event, or a serious adverse event.



Secondary Outcome Measures :
  1. Duration of response [Part 2] [ Time Frame: 1 year ]
  2. Progression-free survival [Part 2] [ Time Frame: 1 year ]
  3. Overall survival [Part 2] [ Time Frame: 1 year ]
  4. Number of participants with serious and non-serious adverse events (AEs) by the end of Part 2 [ Time Frame: 2 years ]


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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:

  • Age ≥ 18 years
  • Unresectable stage III or stage IV melanoma which is histologically confirmed at the treating institution with KIT mutation(s) not known to be resistant to PLX3397
  • Presence of measurable lesions by Response Evaluation Criteria in Solid Tumors
  • Eastern Cooperative Oncology Group (ECOG) performance Status (PS) 0-2
  • Life expectancy ≥ 3 months
  • Adequate organ and bone marrow function
  • Women of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use an effective form of contraception from the time of the negative pregnancy test up to 3 months after the last dose of study drug. Women of non-child-bearing potential must have been postmenopausal for ≥ 1 year or surgically sterile.
  • Fertile men must agree to use an effective method of birth control during the study and for up to 3 months after the last dose of study drug.
  • Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements

Exclusion Criteria:

  • Prior treatment with a KIT inhibitor for melanoma
  • Presence of NRAS or BRAF mutation
  • Exposure to any investigational drug within 28 days or unresolved adverse effects from previous therapy
  • Symptomatic brain metastases.
  • Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Sponsor
  • Concomitant treatment with other anti-neoplastic agents (hormonal therapy acceptable)
  • Uncontrolled intercurrent or infectious illness
  • Major surgical procedure or significant traumatic injury within 14 days of initiating study drug or anticipation of the need for major surgery during the study
  • Previous radiotherapy to 25% or more of the bone marrow and/or radiation therapy within 28 days prior to study entry
  • Inability to swallow capsules, or refractory nausea and vomiting, malabsorption, an external biliary shunt, or significant bowel resection that would preclude adequate absorption
  • Congestive heart failure (CHF) New York (NY) Heart Association class III or IV; unstable coronary artery disease [myocardial infarction (MI) more than 6 months prior to study entry is permitted] or serious cardiac arrhythmia
  • Baseline QT interval corrected using Fredericia equation (QTcF) ≥ 450 msec (for males) or ≥ 470 msec (for females) at Screening
  • Active or chronic infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV)
  • Known chronic liver disease
  • Women who are breast-feeding or pregnant

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): NCT02975700


Locations
China, Beijing
Beijing Cancer Hospital
Beijing, Beijing, China, 100142
China, Guangdong
Sun Yat-sen Hospital
Guangzhou, Guangdong, China
Korea, Republic of
Samsung Medical Center
Gangnam-gu, Seoul, Korea, Republic of, 06351
Severance Hospital, Yonsei University Health System
Seodaemun-gu, Seoul, Korea, Republic of, 03722
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Daiichi Sankyo Co., Ltd.
Daiichi Sankyo, Inc.
Investigators
Study Director: Global Clinical Leader Daiichi Sankyo, Inc.

Responsible Party: Daiichi Sankyo Co., Ltd.
ClinicalTrials.gov Identifier: NCT02975700     History of Changes
Other Study ID Numbers: PLX108-13
First Posted: November 29, 2016    Key Record Dates
Last Update Posted: December 20, 2017
Last Verified: December 2017

Keywords provided by Daiichi Sankyo, Inc. ( Daiichi Sankyo Co., Ltd. ):
PLX3397
Kit-mutant Melanoma
Unresectable or Metastatic KIT-mutated Melanoma
Developmental Phase I/II

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas