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Hormone Receptor Positive Disease Across Solid Tumor Types: A Phase I Study of Single-Agent Hormone Blockade and Combination Approaches With Targeted Agents to Provide Synergy and Overcome Resistance

NCT01197170 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 277

Last updated 2021-01-22

No results posted yet for this study

Summary

The goal of this clinical research study to find the highest tolerated dose of anastrozole alone or in combination with either everolimus (Afinitor), sorafenib (Nexavar), erlotinib (Tarceva), fulvestrant (Faslodex), or bevacizumab (Avastin) that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied.

Conditions

Interventions

DRUG

Anastrozole

1 mg by mouth daily of a 28 day cycle.

DRUG

Bevacizumab

Starting dose 10 mg by vein on day 1 of a 21 day cycle.

DRUG

Everolimus

Starting dose 5 mg by mouth daily for a 28 day cycle.

DRUG

Sorafenib

Starting dose 200 mg by mouth twice a day of a 28 day cycle.

DRUG

Erlotinib

Starting dose 75 mg by mouth daily for a 28 day cycle.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Filip Janku, MD, PHD · M.D. Anderson Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-07
Primary Completion
2021-01-13
Completion
2021-01-13
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01197170 on ClinicalTrials.gov