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NCT01326481 · ClinicalTrials.gov registry record · Phase 1

Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer

A Phase 1 study of Metastatic Breast Cancer, sponsored by Tracon Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
19
Enrollment target
2
Study locations

NCT01326481: Completed Phase 1 study of Metastatic Breast Cancer, sponsored by Tracon Pharmaceuticals.

NCT01326481 is a Phase 1 study of Metastatic Breast Cancer that has completed, run by Tracon Pharmaceuticals. The registered enrollment target is 19 participants, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01326481, a Phase 1 study of Metastatic Breast Cancer, has completed, sponsored by Tracon Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
19 participants
Enrollment target
2
Study locations

Study Summary

The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer.

Primary Outcome

Assess safety and dose limiting toxicity by dose cohort and coding all terms utilized MedDRA version 14.1.

Conditions Studied

Interventions

  • DRUG Capecitabine
  • DRUG TRC105

Study Locations (2)

Alabama

  • University of Alabama at Birmingham - Birmingham

New York

  • Roswell Park Cancer Institute - Buffalo

Trial Details

FieldValue
Enrollment Target 19 participants
Start Date 2011-06
Est. Completion 2014-12
Phase Phase 1
Tracon Pharmaceuticals

16 total trials

What the finished NCT01326481 record still lists

NCT01326481 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 205-participant average among 139 other Metastatic Breast Cancer trials with a reported enrollment target (91% lower).

The record links to 1 condition, with Metastatic Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Capecitabine is the first listed.

NCT01326481 reports a single indexed study location in Alabama, New York.

Frequently Asked Questions

What is clinical trial NCT01326481 about?

NCT01326481 is a clinical study titled "Open Label Dose-Finding Study of TRC105 Plus Capecitabine for Metastatic Breast Cancer". The purpose of this study is to determine the recommended phase 2 dose and overall safety and tolerability of TRC105 when given in combination with capecitabine for the treatment of patients with progressive or recurrent metastatic breast cancer.

What is the current status of trial NCT01326481?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 19 participants. The study started on 2011-06. Estimated completion is 2014-12.

What conditions does trial NCT01326481 study?

This clinical trial studies the following conditions: Metastatic Breast Cancer.

What interventions are being tested in trial NCT01326481?

The interventions under investigation include: Capecitabine (DRUG), TRC105 (DRUG).

Who is sponsoring clinical trial NCT01326481?

This trial is sponsored by Tracon Pharmaceuticals, which has 16 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01326481 being conducted?

This trial has 2 study locations across Alabama, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Metastatic Breast Cancer

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 NCT01326481's enrollment target sits among peer trials

19 123rd of 139 higher than 16 of 139 other Metastatic Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Metastatic Breast Cancer 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 NCT01326481, the US trial registry maintained by the National Library of Medicine. NCT01326481 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.