Study of Ixazomib and Erlotinib in Solid Tumors

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02942095
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Ixazomib — DRUG
    Dose Escalation Phase Starting Dose: Ixazomib 3.0 mg on Days 1, 8, and 15 of a 28-day cycle. Dose Expansion Phase: Maximum tolerated dose from Dose Escalation Phase
  • Erlotinib — DRUG
    Dose Escalation and Dose Expansion Phase: Erlotinib 150 mg by mouth on Days 1 - 28 of a 29 day cycle.

Study Details

The goal of this clinical research study is to find the highest tolerable dose of the combination of ixazomib and erlotinib that can be given to patients with advanced solid tumors. The safety of these drugs will also be studied. This is an investigational study. Erlotinib is FDA approved and commercially available to treat non-small cell lung cancer, but its use in advanced solid cancer is considered investigational. Ixazomib is FDA approved. The study doctor can explain how the study drugs are designed to work. Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.

Key Dates

First listed
Oct 21, 2016
Start date
Mar 6, 2017
Status verified
Apr 2023
Primary completion
Dec 7, 2022
Completion
Dec 7, 2022

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Group - Ixazomib + Erlotinib
    Dose Escalation Phase: Participants take Ixazomib capsules by mouth on Days 1, 8, and 15 of each 28 day cycle starting with Dose Level 1. Participants take Erlotinib tablets by mouth on Days 1 - 28 of each 28 day cycle.
  • Experimental: Dose Expansion Group - Non Small Cell Lung Cancer
    Dose Expansion Phase : Participants take Ixazomib capsules by mouth on Days 1, 8, and 15 of each 28 day cycle at the maximum tolerated dose from Dose Escalation Phase. Participants take Erlotinib tablets by mouth on Days 1 - 28 of each 28 day cycle.
  • Experimental: Dose Expansion Group - Pancreatic Ductal Adenocarcinoma
    Dose Expansion Phase : Participants take Ixazomib capsules by mouth on Days 1, 8, and 15 of each 28 day cycle at the maximum tolerated dose from Dose Escalation Phase. Participants take Erlotinib tablets by mouth on Days 1 - 28 of each 28 day cycle.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of Ixazomib and Erlotinib in Advanced Cancer Participants [ Time Frame: 28 days ]

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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