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NCT01197170 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Solid Tumors and Advanced Cancer, sponsored by M.D. Anderson Cancer Center.

Completed
Registry status
Phase 1
Development phase
277
Enrollment target
1
Study location

NCT01197170: Completed Phase 1 study of Solid Tumors and Advanced Cancer, sponsored by M.D. Anderson Cancer Center.

NCT01197170 is a Phase 1 study of Solid Tumors and Advanced Cancer that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 277 participants, roughly in line with the 282-participant average among 125 other Solid Tumors trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01197170, a Phase 1 study of Solid Tumors and Advanced Cancer, has completed, sponsored by M.D. Anderson Cancer Center.

COMPLETED
Registry status
Phase 1
Development phase
277 participants
Enrollment target
1
Study location

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.

Primary Outcome

MTD defined as highest dose at which no more than 1 of 6 evaluable patients has had a dose limiting toxicity (DLT). Six patients should be treated before the dose is declared as MTD. DLTs defined as adverse events (AEs) related to study agents which occurs during the first cycle of treatment.

Interventions

  • DRUG Bevacizumab
  • DRUG Anastrozole
  • DRUG Everolimus
  • DRUG Sorafenib
  • DRUG Erlotinib

Study Locations (1)

Texas

  • University of Texas MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 277 participants
Start Date 2010-09-07
Est. Completion 2021-01-13
Phase Phase 1
M.D. Anderson Cancer Center

2,692 total trials

What the finished NCT01197170 record still lists

NCT01197170 is an interventional study that assigns participants to a tested intervention. The registered 277 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 282-participant average among 125 other Solid Tumors trials with a reported enrollment target.

The record links to 2 conditions, with Solid Tumors appearing as the primary indexed condition, and to 5 interventions - of which Bevacizumab is the first listed.

NCT01197170 reports a single indexed study location in Texas.

Frequently Asked Questions

What is clinical trial NCT01197170 about?

NCT01197170 is a clinical study titled "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". 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 saf...

What is the current status of trial NCT01197170?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 277 participants. The study started on 2010-09-07. Estimated completion is 2021-01-13.

What conditions does trial NCT01197170 study?

This clinical trial studies the following conditions: Solid Tumors, Advanced Cancer.

What interventions are being tested in trial NCT01197170?

The interventions under investigation include: Bevacizumab (DRUG), Anastrozole (DRUG), Everolimus (DRUG), Sorafenib (DRUG), Erlotinib (DRUG).

Who is sponsoring clinical trial NCT01197170?

This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01197170 being conducted?

This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Solid Tumors

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01197170's enrollment target sits among peer trials

277 21st of 125 higher than 105 of 125 other Solid Tumors trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Solid Tumors trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01197170, the US trial registry maintained by the National Library of Medicine. NCT01197170 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.