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NCT Number: NCT02219711

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

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.

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Key information

Conditions

Advanced Cancer Adenocarcinoma Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Renal Cell Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Head and Neck Neoplasms Kidney Diseases Kidney Neoplasms Lung Diseases Lung Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Prostatic Diseases Prostatic Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Chungbuk National University Hospital, Cheongju-si, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MGCD516

Drug

MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water.

Other names: Sitravatinib

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Mirati Therapeutics Inc.

Industry

Registry information

Official study title

A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies

Important dates

Study start
2014
Primary completion
2022
Study completion
2022
First posted
Aug 19, 2014
Registry last updated
Mar 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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