Systematic Review of Gossypol/at-101 in Cancer Clinical Trials


, 15 , 144 8 of 33 Table 1



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Systematic Review of GossypolAT-101 in Cancer Clin

2022
,
15
, 144
8 of 33
Table 1.
Cont.
NCT Number
Publication Date
Country
Reference
Tumor Entity
Patient Diagnosis
n
Trial Design
Treatment Type
and Frequency
Toxicity
Reported Outcomes/Conclusions
NCT n. a.
1992
UK
[
89
]
advanced human cancer
n = 34
phase I

racemic gossypol acetic
acid as dose
escalating regimen

part I: weekly escalating
doses of gossypol ranging
from 30 to 180 mg

part II: repeat doses
(30 mg), which were given
initially twice weekly, then
daily and, finally,
twice daily

no major adverse events

no evidence of
hematological or
biochemical disturbance

daily median limiting
dose = 30 mg,
weekly = 120 mg

toxic side effects, emesis is
dose related (severe in
13/16 patients),
diarrhea, lethargy

no evidence in liver
metastases, bone marrow
toxicity, hypokalaemia
related to gossypol

no clear correlation between
serum drug levels and
gossypol dose

23 patients completed at least
three weeks treatment

20 patients assessable
for response

no tumor regression

SD: three patients (for 16, 23 and
19 weeks), PD: 20 patients

achieved gossypol blood levels
were lower than in vitro

(

)-enantiomer/AT-101
suggested to use in further
clinical trials
Abbreviations: ADT, androgen deprivation therapy; AE, adverse event; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BID, twice daily; CR, complete response;
CRPC, castrate-resistant prostate cancer; DLT, dose-limiting toxicity; ES-SCLC, extensive stage—small cell lung cancer; GI, gastrointestinal; mOS, median overall survival; MR, minor
response; n, number of subjects; n. a., not available; OR, objective response; OS, overall survival; PD, progressive disease; PFS, progression-free survival; PR, partial response; PSA,
prostate-specific antigen; SAE, serious adverse event; SD, stable disease.


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