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Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer

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ClinicalTrials.gov Identifier: NCT02219711
Recruitment Status : Recruiting
First Posted : August 19, 2014
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:

MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.

During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations.

Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.


Condition or disease Intervention/treatment Phase
Advanced Cancer Drug: MGCD516 Phase 1

Detailed Description:

During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed.

During the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis:

Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA, KIT or CBL.

Head and neck squamous cell carcinoma with genetic alterations in MET.

Clear cell renal cell carcinoma refractory to angiogenesis inhibitors.

Metastatic prostate cancer with bone metastases.

Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 260 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies
Study Start Date : August 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MGCD516
MGCD516 oral capsule, administered in escalating doses in Phase 1, beginning with daily dosing and exploring other regimens as necessary, in 21 or 28 days cycles
Drug: MGCD516
MGCD516 capsules will be taken with water.




Primary Outcome Measures :
  1. Type of dose limiting adverse event [ Time Frame: Up to 3 weeks on treatment ]
  2. Area under the plasma concentration versus time curve (AUC) of MGCD516 [ Time Frame: Up to 72 hours ]
  3. Peak Plasma Concentration (Cmax) of MGCD516 [ Time Frame: Up to 72 hours ]

Secondary Outcome Measures :
  1. Kind of metabolites of MGCD516 in blood plasma [ Time Frame: Up to 9 weeks on treatment ]
  2. Concentration of selected marker proteins in blood plasma [ Time Frame: Up to 9 weeks on treatment ]
    Proteins include VEGF A, soluble VEGF-R2 and soluble MET

  3. Percent of patients having objective disease response to treatment [ Time Frame: Up to 1 year on treatment ]
    Response Evaluation Criteria in Solid Tumors (RECIST 1.1)



Information from the National Library of Medicine

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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:

  • Metastatic or unresectable solid tumor malignancy
  • Standard treatment is not available
  • Adequate bone marrow and organ function

Exclusion Criteria:

  • History of a significant cardiovascular illness
  • Prolonged corrected QT (QTc) interval
  • Left ventricular ejection fraction < 40%
  • Symptomatic or uncontrolled brain metastases
  • Other active cancer

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): NCT02219711


Contacts
Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 miratistudylocator@emergingmed.com

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Sponsors and Collaborators
Mirati Therapeutics Inc.

Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT02219711     History of Changes
Other Study ID Numbers: 516-001
First Posted: August 19, 2014    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018

Keywords provided by Mirati Therapeutics Inc.:
MGCD516
MET
AXL
RET
TRK
NTRK
DDR2
KDR
VEGFR
PDGFRA
KIT
Tyrosine kinase inhibitor
NSCLC
Non-small cell lung cancer
Head and neck cancer
Renal cell carcinoma
Prostate cancer
Phase 1
CBL

Additional relevant MeSH terms:
Neoplasms