Phase 1 Study of ATR-101 in Subjects With Advanced Adrenocortical Carcinoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Atterocor, Inc.
Sponsor:
Information provided by (Responsible Party):
Atterocor, Inc.
ClinicalTrials.gov Identifier:
NCT01898715
First received: July 10, 2013
Last updated: August 21, 2014
Last verified: August 2014
  Purpose

This first-in-human study is designed to establish the safety and tolerability of ATR-101 in patients with advanced adrenocortical carcinoma whose tumor has progressed on standard therapy. Information will also be collected to determine how long ATR-101 stays in the blood, and if any effect on tumor progression is seen. Biomarkers (blood and urine tests) will determine if any effects on production of steroid hormones (cortisol, aldosterone, estrogen and testosterone) are seen.


Condition Intervention Phase
Adrenocortical Carcinoma
Adrenal Cancer
ACC
Drug: ATR-101
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 1 Study of the Safety and Tolerability of ATR-101 in Adrenocortical Carcinoma

Resource links provided by NLM:


Further study details as provided by Atterocor, Inc.:

Primary Outcome Measures:
  • Frequency of dose-limiting toxicity and determination of maximum tolerated dose [ Time Frame: Occurrence of DLT at 28 days ] [ Designated as safety issue: Yes ]
    Adverse events will be recorded and tabulated by grade and system organ class according to CTCAE v 4.03. Laboratory measures and ECGs will be assessed.


Secondary Outcome Measures:
  • Area under the plasma concentration versus time curve (AUC) of ATR-101 [ Time Frame: Day 1 and Day 22 ] [ Designated as safety issue: No ]
    Plasma levels of ATR-101 will be assessed after daily oral dosing and pharmacokinetic parameters will be calculated.

  • Change in plasma cortisol levels [ Time Frame: Baseline and day 22 ] [ Designated as safety issue: No ]
  • Change in objective measurement of tumor size [ Time Frame: Baseline and 8 weeks ] [ Designated as safety issue: No ]
    CT or MRI scans will be read according to RECIST 1.1


Estimated Enrollment: 59
Study Start Date: July 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ATR-101
ATR-101 will be administered as capsules by mouth once per day to ascending dose cohorts
Drug: ATR-101

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

18 years;

  • Clinical confirmation of adrenocortical carcinoma that is locally advanced or metastatic and not amendable to surgical resection;
  • Failed or declined mitotane (adjuvant or therapeutic) therapy or a platinum-based chemotherapy regimen;
  • Able to understand and comply with the protocol requirements;
  • Willing and able to provide informed consent.

Exclusion Criteria:

  • Mitotane level > 5
  • Use of contraindicated concomitant medications
  • Unstable medical condition that, in the judgment of the investigator, could interfere with study procedures or data interpretation.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898715

Contacts
Contact: Marian Ijzerman, PhD 734-845-9300
Contact: Marianne R Plaunt, PhD 734-249-6030

Locations
United States, Michigan
University of Michigan Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48103
Contact: Cancer Answer Line    800-865-1125      
Principal Investigator: David C. Smith, MD         
United States, Texas
MDAnderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Trial Clinic    713-563-1930      
Principal Investigator: Aung Naing, MD         
Sponsors and Collaborators
Atterocor, Inc.
  More Information

No publications provided

Responsible Party: Atterocor, Inc.
ClinicalTrials.gov Identifier: NCT01898715     History of Changes
Other Study ID Numbers: ATR-101-001
Study First Received: July 10, 2013
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Atterocor, Inc.:
Adrenocortical carcinoma
Adrenal cancer
ACC

Additional relevant MeSH terms:
Adrenal Gland Diseases
Adrenocortical Carcinoma
Carcinoma
Adenocarcinoma
Adrenal Cortex Diseases
Adrenal Cortex Neoplasms
Adrenal Gland Neoplasms
Endocrine Gland Neoplasms
Endocrine System Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on October 20, 2014