Meta AnalysisID 2637

棉酚/AT-101在癌症临床试验中的系统评价

CRD42021297142

Is there evidence that the use of oral gossypol / AT-101 is safe and clinically effective in the treatment of various cancers?

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Record Fields

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Meta Analysis Id
2637
Evidence Id
11195
Core Evidence Id
11195
Source Meta Analysis Id
2589
Herb2 Meta Analysis Id
HBMA002589
Crd Id
CRD42021297142
Title
Systematic Review of Gossypol / AT-101 in Cancer Clinical Trials
Review Question
Is there evidence that the use of oral gossypol / AT-101 is safe and clinically effective in the treatment of various cancers?
Study Type Included
The intervention of interest was the application of gossypol / AT-101 alone or in combination with standard cancer therapies. All identified uncontrolled studies or controlled studies, that contained comparisons against no treatment, placebo, or other standard of care therapies are relevant. Randomized controlled trials were of primary interest, but all study designs were incorporated in the final search.
Condition Being Studied
Various types of cancer, plant compound
Participant
The population of interest for this review included patients with a current diagnosis of cancer of any type and stage.
Animal
Human Disease Modelled
Intervention
The interventions of interest are the application of gossypol / AT-101 alone or in combination with standard cancer therapies. Phase I and II trials as well as single arm and randomized trials are included in this search. The results of clinical trials in which cancer patients were treated with gossypol / AT-101, either as a single agent or in combination with standard therapies.
Comparator Control
Uncontrolled studies or controlled studies, that contained comparisons against no treatment, placebo, or other standard of care therapies are relevant. Following retrieval of the studies, three authors inspected the studies (OR, MM, and CL), eliminated duplicates, and removed all studies that were not clinical trials or not relevant to the subject matter. These authors then screened the remaining studies a second time, removing trials that examined tumor models, any animal intervention, antifertility and / or contraceptive, zinc level and gossypol-related hypokalemia, trials with only methodical investigation, and with possible screening parameters related to cancer prognosis but not to gossypol / AT-101 activity. Databases, U.S. National Library of Medicine, as well as ClinicalTrials.gov page, and search terms “gossypol”, “AT-101”, “cancer”, and “tumor” were used to find out the available ClinicalTrials.gov Identifier (NCT number) and to supplement or monitor further study details.
Main Outcome
Referenced outcomes involve Common Terminology Criteria for Adverse Events (CTCAE), Response Evaluation Criteria In Solid Tumors (RECIST), parameters for intact liver function (like serum aspartate aminotransferase (AST), alanine aminotransferase (ALT), and albumin values.
Outcome Measure
Additional Outcome
Dose, toxicity, tolerability, plasma levels, correlation with tumor markers.
Study Method
Intervention, Narrative synthesis, Pre-clinical, Systematic review
Keyword
Contraceptive Agents, Male; Gossypol; Humans; Male; Neoplasms; gossypol acetic acid
Contact
Olga Renner [email protected]
Organisational Affiliation
UNIVERSITY OF HOHENHEIM, 70599, Stuttgart, Germany www.uni-hohenheim.de
Funding Source
Markus Burkard and Sascha Venturelli were supported by listed below grants. Grant number(s) <span style=font-size: 14px>State the funder, grant or award number and the date of award</span> PASCOE pharmazeutische Praeparate GmbH, the Ministry of Rural Affairs and Consumer Pro-tection Baden-Wuerttemberg (AZ: 34-9185.90-1), and the Else-Uebelmesser-Stiftung (grant no. D3021947; reference: GzV 1.14).
Other Selection Criteria
Final Publication
Same Topic Review
Published Protocol
Review Type
Language
English
Country
Germany
Review Stage
Review Completed not published
First Submission Date
2021-12-08
Registration Date
2021-12-08
Anticipated Start Date
2021-08-01
Anticipated Completion Date
2022-01-07
Title Cn
棉酚/AT-101在癌症临床试验中的系统评价
Title En
Systematic Review of Gossypol / AT-101 in Cancer Clinical Trials
Bilingual Status
complete