Trametinib and Navitoclax in Treating Patients With Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02079740
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Metastatic Malignant Solid Neoplasm
  • Refractory Malignant Solid Neoplasm
  • Unresectable Malignant Solid Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Computed Tomography — PROCEDURE
    Undergo conventional CT or PET/CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Navitoclax — BIOLOGICAL
    Given PO
  • Positron Emission Tomography — PROCEDURE
    Undergo PET/CT
  • Trametinib — DRUG
    Given PO

Study Details

This phase Ib/II trial studies the side effects and best dose of trametinib and navitoclax and how well they work in treating patients with solid tumors that have spread to other places in the body (advanced or metastatic). Trametinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Navitoclax inhibits members of the BCL2 family of proteins that are believed to play key roles in promoting the survival of cancer cells. It may stop the growth of cancer cells by blocking Bcl-2, Bcl-XL, and Bcl-w, proteins needed for cancer cell survival. Giving trametinib and navitoclax may help stop the growth of tumor cells.

Key Dates

Start date
Mar 26, 2014
Status verified
Mar 2026
Primary completion
Dec 1, 2022
Completion
Mar 9, 2027

Study Design

Enrollment
96 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (trametinib, navitoclax)
    Patients receive trametinib PO QD and navitoclax PO QD on days 1-28 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. If unacceptable toxicity is observed, patients may receive trametinib PO QD on days 1-14.

Primary Outcome Measure

(Phase 1b) Maximal Tolerated Dose of Trametinib and Navitoclax [ Time Frame: Within the first 42 days of treatment ]

Locations (2)

FacilityCityStateZIPSite coordinators
Dana-Farber Cancer InstituteBostonMassachusetts02215-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-

Find similar trials in Boston, MA

By research site
Dana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital Cancer Center· Boston, MA

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