MLN9708 and Vorinostat in Patients With Advanced p53 Mutant Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02042989
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Cancers

Eligibility Criteria

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

Interventions

  • MLN9708 — DRUG
    Dose Escalation Phase - Starting Dose of MLN9708: 3 mg by mouth on day 1, 8 and 15. Dose Expansion Phase Starting Dose of MLN9708: Maximum tolerated dose from Dose Escalation Phase.
  • Vorinostat — DRUG
    Dose Escalation Phase - Starting Dose of Vorinostat: 100 mg by mouth twice a day, total of 200 mg/day Days 1 to 21. Dose Expansion Phase Starting Dose of Vorinostat: Maximum tolerated dose from Dose Escalation Phase.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of the combination of MLN9708 and vorinostat that can be given to patients with advanced solid tumors. The safety of these drugs will also be studied.

Key Dates

Start date
Jun 27, 2014
Status verified
Jul 2022
Primary completion
Jan 22, 2020
Completion
Jan 22, 2020

Study Design

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

Arms

  • Experimental: MLN9708 and Vorinostat
    Dose Escalation Phase: Starting Dose of MLN9708 3 mg by mouth on day 1, 8 and 15. Starting Dose of Vorinostat: 100 mg by mouth twice a day, total of 200 mg/day Days 1 to 21. Dose Expansion Phase Starting Doses of MLN9708 and Vorinostat: Maximum tolerated dose from Dose Escalation Phase.

Primary Outcome Measure

Maximum Tolerated Doses (MTD) of MLN9708 and Vorinostat [ Time Frame: After 2, 28 day cycles ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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