Evidence map›Paper›PMID 31172443›Full record

Trial reportInvestigational new drugs2019

A phase II study of the orally administered negative enantiomer of gossypol (AT-101), a BH3 mimetic, in patients with advanced adrenal cortical carcinoma.

Hao Xie, Jun Yin, Manisha H Shah, Michael E Menefee, Keith C Bible, Diane Reidy-Lagunes, Madeleine A Kane, David I Quinn, David R Gandara, Charles Erlichman and 1 more

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Investigational new drugs, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 30 citations in OpenAlex.

  1. BCL-2 and BCL-xL in Cancer: Regulation, Function, and Therapeutic Targeting.International journal of molecular sciences · 2026
    Review
  2. Review
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  4. Review
  5. Review
  6. Article
  7. Article
  8. Review
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  10. Systematic Review of Gossypol/AT-101 in Cancer Clinical Trials.Pharmaceuticals (Basel, Switzerland) · 2022
    Review
  11. Article
  12. Article
  13. Review
  14. Article
  15. The Biological Role of LRPPRC in Human Cancers.Cancer control : journal of the Moffitt Cancer Center
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 1 country.

Hao XieMayo Clinic Cancer Center, 200 First St. SW, Rochester, MN, 55905, USA.ORCID 0000-0002-9640-4055
Jun YinMayo Clinic Cancer Center, 200 First St. SW, Rochester, MN, 55905, USA.
Manisha H ShahDivision of Medical Oncology, Department of Internal Medicine, The Ohio State University Comprehensive Cancer Center, Columbus, OH, USA.
Michael E MenefeeFDA, Silver Spring, MD, 20993, USA.
Keith C BibleMayo Clinic Cancer Center, 200 First St. SW, Rochester, MN, 55905, USA.
Diane Reidy-LagunesGastrointestinal Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Madeleine A KaneDepartment of Medicine and Division of Medical Oncology, University of Colorado, Anschutz Medical Campus, Aurora, CO, USA.
David I QuinnUniversity of Southern California Norris Comprehensive Cancer Center, Hospital and Clinics, Los Angeles, CA, 90033, USA.
David R GandaraUC Davis Comprehensive Cancer Center, Sacramento, CA, USA.
Charles ErlichmanMayo Clinic Cancer Center, 200 First St. SW, Rochester, MN, 55905, USA.
Alex A AdjeiMayo Clinic Cancer Center, 200 First St. SW, Rochester, MN, 55905, USA. adjei.alex@mayo.edu.
Mayo Clinic · USMemorial Sloan Kettering Cancer Center · USThe Ohio State University · USUC Davis Comprehensive Cancer CenterUnited States Food and Drug Administration · USUniversity of Colorado Anschutz Medical Campus · USUniversity of Southern California · US

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
USC/NORRIS COMPREHENSIVE CANCER CENTER (CORE) SUPPORTP30CA014089 · NCI · UNIVERSITY OF SOUTHERN CALIFORNIA · PI Fumito Ito · 1985 to 2026
$181.4M
Phase I Molecular and Clinical Pharmacodynamic Trials ETCTNUM1CA186717 · NCI · BECKMAN RESEARCH INSTITUTE/CITY OF HOPE · PI A. Dimitrios Colevas, Alexey V. Danilov · 2014 to 2026
$19.8M
UM1 Supplement for Early Therapeutic Trials with Phase 2 IntentUM1CA186712 · NCI · OHIO STATE UNIVERSITY · PI SUSANNE M ARNOLD, WILLIAM E. CARSON · 2014 to 2026
$19.3M
EARLY THERAPEUTICS DEVELOPMENT WITH PHASE 2 EMPHASIS-261017104N01CA017104 · NCI · MAYO CLINIC COLL OF MEDICINE, ROCHESTER · 2002 to 2005
–
NCI NIH HHS P30 CA008748NCI NIH HHS P30 CA014089NCI NIH HHS UM1 CA186712NCI NIH HHS UM1 CA186717
6 · The paper itself

Abstract

Background Adrenal cortical carcinoma (ACC) is a rare cancer with treatment options of limited efficacy, and poor prognosis if metastatic. AT-101 is a more potent inhibitor of B cell lymphoma 2 family apoptosis-related proteins than its racemic form, gossypol, which showed preliminary clinical activity in ACC. We thus evaluated the efficacy of AT-101 in patients with advanced ACC. Methods Patients with histologically confirmed metastatic, recurrent, or primarily unresectable ACC were treated with AT-101 (20 mg/day orally, 21 days out of 28-day cycles) until disease progression and/or prohibitive toxicity. The primary endpoint was objective response rate, wherein a Response Evaluation Criteria In Solid Tumors (RECIST) partial response rate of 25% would be considered promising and 10% not, with a Type I error of 10% and 90% power. In a 2-stage design, 2 responses were required of the first 21 assessable subjects to warrant complete accrual of 44 patients. Secondary endpoints included safety, progression-free survival and overall survival. Results This study accrued 29 patients between 2009 and 2011; median number of cycles was 2. Seven percent experienced grade 4 toxicity including cardiac troponin elevations and hypokalemia. None of the first 21 patients attained RECIST partial response; accordingly, study therapy was deemed ineffective and the trial was permanently closed. Conclusions AT-101 had no meaningful clinical activity in this study in patients with advanced ACC, but demonstrated feasibility of prospective therapeutic clinical trials in this rare cancer.

Indexed as

Adrenal Cortex NeoplasmsAdrenocortical CarcinomaAdultAgedAntineoplastic Agents, PhytogenicFemaleGossypolHumansMaleMiddle AgedProto-Oncogene Proteins c-bcl-2Response Evaluation Criteria in Solid TumorsAntineoplastic Agents, PhytogenicGossypolgossypol acetic acidProto-Oncogene Proteins c-bcl-2Adrenal cortical carcinomaApoptosisAT-101Gossypol

Identifiers

PMID31172443
PMCPMC7515770
OpenAlexW2953447885

What OpenQuestion holds

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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.