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DRUG:

megestrol

i
Other names: BDH 1298
Company:
Generic mfg.
Drug class:
Progesterone receptor agonist
2d
Prospective Study for Endometrial Carcinoma and Hyperplasia in Childbearing-age Women (clinicaltrials.gov)
P=N/A, N=75, Recruiting, Women's Hospital School Of Medicine Zhejiang University
New trial
|
TP53 wild-type
|
megestrol
3d
iKanEat: A Randomized-controlled, Multi-center Trial of Megestrol for Chronic Oral Food Refusal in Children (clinicaltrials.gov)
P4, N=60, Recruiting, University of Kansas Medical Center | Trial completion date: Jun 2024 --> Jun 2025 | Trial primary completion date: Jun 2024 --> Jun 2025
Trial completion date • Trial primary completion date
|
megestrol
15d
Correlation between steroid receptor expression and response to progestational therapy in patients with atypical endometrial hyperplasia or cancer. (PubMed, Gynecol Oncol Rep)
Retrospective cohort study collected data for patients with AEH or EMCA who had an endometrial sample after receiving conservative therapy utilizing either Megestrol acetate or Levonorgestrel Intrauterine device (IUD). Immunohistochemistry (IHC) was performed on pre- and post- treatment biopsy samples to assess androgen receptor (AR), estrogen receptor (ER), and progesterone receptor (PR) expression...Patients who successfully responded to the treatment demonstrated a significantly greater decrease in IHC scores after the treatment compared to those who did not respond (p = 0.009). Steroid receptor expression could be used as a possible biomarker for response to progestin therapy in patients undergoing conservative management for AEH and EMCA.
Journal
|
ER (Estrogen receptor) • PGR (Progesterone receptor) • AR (Androgen receptor)
|
PGR expression
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megestrol
25d
Gonadotropin-releasing Hormone Agonist (GnRHa) Plus Letrozole In Young Women With Early Endometrial Cancer (clinicaltrials.gov)
P2, N=104, Recruiting, Fudan University | Trial primary completion date: Mar 2024 --> Mar 2025
Trial primary completion date
|
letrozole • megestrol
3ms
Enrollment open • Metastases
|
AKT1S1 (AKT1 Substrate 1)
|
ipatasertib (RG7440) • megestrol
3ms
Clinical Trial of Rapid Progressive Central Precocious Puberty With Integrative Chinese and Western Medicine (clinicaltrials.gov)
P4, N=126, Completed, Children's Hospital of Fudan University | Recruiting --> Completed
Trial completion
|
megestrol • leuprolide acetate for depot suspension
4ms
Trial completion
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • CDH1 (Cadherin 1) • CDH2 (Cadherin 2)
|
ER positive • HER-2 negative • CDH1 expression
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letrozole • megestrol
4ms
Megestrol Acetate Plus Rosuvastatin in Young Women With Early Endometrial Carcinoma (clinicaltrials.gov)
P2, N=48, Recruiting, Fudan University | Trial completion date: Aug 2023 --> Aug 2025 | Trial primary completion date: Aug 2023 --> Aug 2025
Trial completion date • Trial primary completion date
|
megestrol
4ms
Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer (clinicaltrials.gov)
P2, N=50, Recruiting, National Cancer Institute (NCI) | Trial completion date: May 2024 --> Nov 2024 | Trial primary completion date: May 2024 --> Nov 2024
Trial completion date • Trial primary completion date
|
megestrol
5ms
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy (clinicaltrials.gov)
P2, N=44, Active, not recruiting, City of Hope Medical Center | Trial primary completion date: Dec 2023 --> Nov 2024 | Trial completion date: Dec 2023 --> Nov 2024
Trial completion date • Trial primary completion date
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megestrol
6ms
New P1 trial
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megestrol
6ms
Trial suspension • Metastases
|
AKT1S1 (AKT1 Substrate 1)
|
ipatasertib (RG7440) • megestrol
6ms
Antiangiogenics in Malignant Granular Cell Tumors: Review of the Literature. (PubMed, Cancers (Basel))
Other reported targeted therapies for malignant GCTs included pazopanib in combination with crizotinib, which showed disease control for four months in one patient, and a PI3K inhibitor which achieved disease control for nine months in another patient. Dasatinib and megestrol were ineffective in two other different patients. Pazopanib has been demonstrated to be active in advanced GCTs and may be considered as a preferable treatment option.
Review • Journal
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PDGFRB (Platelet Derived Growth Factor Receptor Beta) • ATP6AP1 (ATPase H+ Transporting Accessory Protein 1)
|
Xalkori (crizotinib) • dasatinib • Votrient (pazopanib) • megestrol
6ms
Phase classification • Metastases
|
AKT1S1 (AKT1 Substrate 1)
|
ipatasertib (RG7440) • megestrol
6ms
Clinical relevance of circulating ESR1 mutations during endocrine therapy for advanced hormone-dependent endometrial carcinoma. (PubMed, BMC Cancer)
ESR1 mutations do not seem to be involved in the mechanisms of resistance to AI or M in HR+ endometrial cancer. The clinical relevance of their detection is not demonstrated.
Retrospective data • Journal • Metastases
|
ER (Estrogen receptor)
|
ER mutation • ER Y537S • ER D538G • ESR1 mutation • ER Y537N • ER Y537C
|
megestrol
7ms
MA-EEC: Study of Megestrol Acetate in Grade 2 Endometrioid Endometrial Cancer (clinicaltrials.gov)
P1, N=5, Terminated, Sunnybrook Health Sciences Centre | N=73 --> 5 | Trial completion date: Sep 2024 --> Oct 2023 | Recruiting --> Terminated | Trial primary completion date: Apr 2024 --> Oct 2023; Slow enrollment
Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Surgery
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TP53 wild-type
|
megestrol
8ms
Megestrol Acetate Compared With Megestrol Acetate and Metformin to Prevent Endometrial Cancer (clinicaltrials.gov)
P2, N=50, Recruiting, National Cancer Institute (NCI) | Trial completion date: Oct 2023 --> May 2024 | Trial primary completion date: Oct 2023 --> May 2024
Trial completion date • Trial primary completion date
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ER (Estrogen receptor) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog) • CASP3 (Caspase 3) • PAX2 (Paired Box 2)
|
megestrol
8ms
Feasibility and Activity of Megestrol Acetate in Addition to Etoposide, Doxorubicin, Cisplatin, and Mitotane as First-Line Therapy in Patients with Metastatic/Unresectable Adrenocortical Carcinoma with Low Performance Status. (PubMed, Cancers (Basel))
No differences in PFS and OS curves were observed; the CBR was 75.0% and 60.4%, respectively. (4) The association of EDP-M + megestrol acetate in ACC pts with a low PS is feasible and well tolerated; its efficacy appeared to be non-inferior to EDP-M administered to pts with a good PS.
Journal • Metastases
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cisplatin • doxorubicin hydrochloride • etoposide IV • Lysodren (mitotane) • megestrol
9ms
Should we abandon hormonal therapy in endometrial cancer? Outcomes of recurrent and metastatic endometrial cancer treated with systemic progestins. (PubMed, Cancer Med)
This real-world data on RMEC suggests there is a role for progestins in select subgroups of women. The PFS for chemotherapy-naïve patients was 17.9 months (14.3, 27.0), versus 6.2 months (3.9, 14.8) following ≥1 line of treatment. The OS was 29.1 months (17.9, 61.1) for chemotherapy-OS was 29.1 months (17.9, 61.1) for chemotherapy-naïve patients versus 23.0 months (10.5, 37.6) for patients previously exposed.
Retrospective data • Journal • Metastases
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megestrol
10ms
Fertility -Preserving Approach In P53 Mutant Grade 2 Endometrioid Endometrial Canser- Cases Presentation (ESGO 2023)
The patient used Megestrol acetate 160 mg for 3 months...Following the procedure, the pathology report showed low-grade endometrial endometrioid carcinoma (FIGO grade 2).Conclusion Fertility-preserving approaches can be considered as a rare option for P53 Mutant Grade2 endometrioid endometrial cancer patients. However, as seen in our case, despite close monitoring, disease progression has been observed.
Clinical
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TP53 (Tumor protein P53) • POLE (DNA Polymerase Epsilon)
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TP53 mutation • POLE mutation
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megestrol
10ms
Fertility-sparing Therapy for Patients With Stage IA Endometrial Cancer (clinicaltrials.gov)
P=N/A, N=57, Recruiting, Peking University People's Hospital
New trial
|
TP53 (Tumor protein P53) • PTEN (Phosphatase and tensin homolog) • MLH1 (MutL homolog 1) • MSH6 (MutS homolog 6) • MSH2 (MutS Homolog 2)
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TP53 expression
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triptorelin • goserelin acetate • megestrol
11ms
Fertility-sparing hormonal treatment in patients with stage I endometrial cancer of grade 2 without myometrial invasion and grade 1-2 with superficial myometrial invasion: Gynecologic Oncology Research Investigators coLLaborAtion study (GORILLA-2001). (PubMed, Gynecol Oncol)
The overall response rate to FST was promising, however, the PD rate was significant during the first 12 months of FST. Therefore, performing thorough endometrial biopsy and imaging studies is essential to strictly evaluate the extent of the disease every 3 months from FST initiation.
Journal
|
megestrol
11ms
New P2 trial • Metastases
|
cisplatin • doxorubicin hydrochloride • etoposide IV • Lysodren (mitotane) • megestrol
1year
A Curious Case of Psychosis (ENDO 2023)
Two of her medications, gabapentin and mirtazapine were thought to be the contributors and were stopped upon admission, however with little improvement...She was ultimately started on hydrocortisone replacement therapy, with subsequent improvement and stabilization of her mental status, mood, and behavior; and was discharged with outpatient Endocrinology follow-up.This case highlights the importance of the broad differentials to consider for mental and behavioral changes...Megestrol is an established cause of secondary adrenal insufficiency, and monitoring is essential with long-term use.*Unless otherwise noted, all abstracts presented at ENDO must not be released to the press or the public until the date and time of presentation...Abstracts presented at a news conference are embargoed until the date and time of the news conference. The Endocrine Society reserves the right to lift the embargo on specific abstracts that are selected for promotion prior to or during ENDO.*
Clinical
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megestrol
1year
CLINICAL IMPLICATION OF MEGESTROL ACETATE IN ADVANCED CANCER: A BIG DATA ANALYSIS FROM HEALTH INSURANCE REVIEW AND ASSESSMENT (HIRA) DATABASE (MASCC-JASCC-ISOO 2023)
Conclusions This study demonstrated that most patients with advanced gastrointestinal and pancreatobiliary cancer required MA prescription. The difference in the incidence of VTE was modest between the MA and non-MA prescription groups (not at the level of statistical significance on multivariate analyses).
Clinical • Reimbursement • Review • US reimbursement • Metastases
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megestrol
1year
Preclinical Evidence of Progesterone as a New Pharmacological Strategy in Human Adrenocortical Carcinoma Cell Lines. (PubMed, Int J Mol Sci)
Our results give support to the role of progesterone in ACC. The involvement of its analog (megestrol acetate) in reducing ACC progression in ACC patients undergoing EDP-M therapy is now under investigation in the PESETA phase II clinical study.
Preclinical • Journal
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MUC1 (Mucin 1) • MMP2 (Matrix metallopeptidase 2)
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cisplatin • doxorubicin hydrochloride • etoposide IV • Lysodren (mitotane) • megestrol
1year
Megestrol Acetate resistance in Estrogen Receptor Positive Advanced Breast Cancer in the MEGA trial (ESMO-BC 2023)
Methods Eligible patients (pts) had metastatic ER+ HER2- BC, and were randomized to receive MA or another HT agent (AHT), Tamoxifen or Exemestane, with 10 pts planned for each arm. Conclusions Translational analysis find evidence of increased transcriptional activity at ER regulated genes in most resistant samples. This could indicate that MA resistant tumours will retain sensitivity to further HT, requiring future research to proof this hypothesis.
Metastases
|
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
|
ER positive • HER-2 negative
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tamoxifen • exemestane • megestrol
1year
Megestrol Acetate With or Without Pterostilbene in Treating Patients With Endometrial Cancer Undergoing Hysterectomy (clinicaltrials.gov)
P2, N=44, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=28 --> 44
Enrollment closed • Enrollment change • IO biomarker
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BCL2 (B-cell CLL/lymphoma 2) • CASP3 (Caspase 3)
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BCL2 expression
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megestrol
over1year
Enrollment open • Metastases
|
ER (Estrogen receptor) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog)
|
ipatasertib (RG7440) • megestrol
over1year
The effect of progestin therapy in advanced and recurrent endometrial cancer: a systematic review and meta-analysis. (PubMed, BJOG)
Progestin therapy is a viable treatment option in patients with advanced stage and recurrent EC with low toxicity and high ORR in PR positive disease. The role of PR expression in relation to progression free survival and overall survival is unclear.
Retrospective data • Review • Journal
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PGR (Progesterone receptor)
|
PGR positive • PGR expression • PGR negative
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megestrol
over1year
Fertility-Sparing Approach in Patients with Endometrioid Endometrial Cancer Grade 2 Stage IA (FIGO): A Qualitative Systematic Review. (PubMed, Biomed Res Int)
Eighty-four patients who took progestins (megestrol acetate, medroxyprogesterone acetate, and/or levonorgestrel-releasing intrauterine devices) were analyzed...The immunohistochemical markers evaluation looks promising in predicting response to conservative treatment. Further large series and randomized clinical trials are needed to confirm these results.
Clinical • Review • Journal
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BIRC5 (Baculoviral IAP repeat containing 5) • SPAG9 (Sperm Associated Antigen 9)
|
megestrol
over1year
Combination chemotherapy and hormone therapy (CHT) in patients with hormone receptor (HR) positive, HER2 negative metastatic breast cancer (MBC): A single-centre retrospective analysis (ESMO Asia 2022)
Methods This was a retrospective analysis of HR-positive, HER2-negative MBC patients who were treated with a combination of CT (capecitabine or oral cyclophosphamide) and HT (tamoxifen or aromatase inhibitor or fulvestrant or megestrol acetate) between Jan 2015 and Dec 2020, with data cutoff in May 2022. CHT was well tolerated with 21 (9.4%) patients experiencing any grade>/=3 toxicity. Conclusions Chemo-hormonal therapy is an effective treatment in heavily pre-treated MBC patients, including those with visceral metastases.
Retrospective data
|
HER-2 (Human epidermal growth factor receptor 2)
|
HR positive • HER-2 negative
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tamoxifen • capecitabine • cyclophosphamide • fulvestrant • megestrol
over1year
BRCA2 Mutated Recurrent Adult Granulosa Cell Tumor Treated with PARP Inhibitor (ESMO Asia 2022)
She was started on neoadjuvant chemotherapy (NACT) with carboplatin paclitaxel...Her disease recurred 12 months later and she received BEP (bleomycin, etoposide, cisplatin) for 4 cycles to obtain a partial response. On disease progression in October 2015, she was treated with pegylated liposomal doxorubicin (PLD) and carboplatin...She remained on megestrol acetate until the next progression in October 2018, and this time she opted for surgery...She was treated with Olaparib without any serious adverse events and had a disease control of 9 months. Unlike epithelial ovarian cancer (EOC) BRCA mutations have not been reported in aGCT. In our patient, multiple platinum-sensitive recurrences similar to EOC and subsequent finding of BRCA2 mutation makes a case for further investigation of such aberrations in aGCT with possible therapeutic implications.
Clinical • BRCA Biomarker • PARP Biomarker
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BRCA2 (Breast cancer 2, early onset) • BRCA (Breast cancer early onset)
|
BRCA2 mutation • BRCA mutation
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Lynparza (olaparib) • cisplatin • carboplatin • paclitaxel • etoposide IV • pegylated liposomal doxorubicin • megestrol • bleomycin
over1year
New P2 trial
|
ER (Estrogen receptor) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog)
|
ipatasertib (RG7440) • megestrol
over1year
Clinical relevance of circulating ESR1 mutations during endocrine therapy for advanced hormone-dependent endometrial carcinoma (ESGO 2022)
The aim of this study was to explore the incidence of circulating ESR1 mutations in patients treated by AA or megestrol acetate (M) for advanced endometrial carcinoma.Methodology: This single-center retrospective study was performed at the Henri Becquerel Center (Rouen) and looked for circulating ESR1 gene mutations by droplet digital PCR (E380Q, L536R, Y537S, Y537N, Y537C, D538G, S463P) in patients with advanced HR+ endometrial carcinoma treated between 2008 and 2020 for at least 30 days by AA or M. Timepoints were before exposure and at progression/during endocrine therapy. 22 patients were included: 13 were treated with AA, 12 of whom progressed; 9 patients were treated with M, 8 of whom progressed... ESR1 mutations do not seem to be involved in the mechanisms of resistance to AA or M in HR+ endometrial cancer. The clinical relevance of their detection is not demonstrated.
Clinical
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ER (Estrogen receptor)
|
ER mutation • ER Y537S • ER D538G • ESR1 mutation • ER Y537N • ER Y537C
|
megestrol
over1year
RAINBO: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (clinicaltrials.gov)
P2/3, N=1611, Recruiting, Leiden University Medical Center | Initiation date: Jun 2022 --> Nov 2021
Trial initiation date
|
ER (Estrogen receptor) • POLE (DNA Polymerase Epsilon)
|
ER positive • MSI-H/dMMR • POLE mutation
|
Lynparza (olaparib) • cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • megestrol
over1year
Weight Management Plus Megestrol Acetate in Early-stage Endometrioid Carcinoma (clinicaltrials.gov)
P2/3, N=89, Recruiting, Xiaojun Chen | Not yet recruiting --> Recruiting
Enrollment open
|
IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha)
|
megestrol
almost2years
RAINBO: Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features (clinicaltrials.gov)
P2/3, N=1611, Recruiting, Leiden University Medical Center | Not yet recruiting --> Recruiting
Enrollment open
|
PGR (Progesterone receptor) • POLE (DNA Polymerase Epsilon)
|
MSI-H/dMMR • POLE mutation • PGR positive
|
Lynparza (olaparib) • cisplatin • carboplatin • Imfinzi (durvalumab) • paclitaxel • megestrol
almost2years
Continuous Vaginal Bleeding Induced By EGFR-TKI in Premenopausal Female Patients With EGFR Mutant NSCLC. (PubMed, Front Oncol)
EGFR signaling, ER, PR and tissue factor expression were analyzed in endometrium tissue obtained from a 43-year-old patient who suffered from continuous vaginal bleeding during treatment with erlotinib and osimertinib. EGFR-TKI unusually induce abnormal vaginal bleeding in premenopausal female NSCLC patients, which may be attributed to progesterone/EGFR/TF signaling. Megestrol acetate may be an available and effective drug for the uncommon adverse effect.
Journal
|
EGFR (Epidermal growth factor receptor)
|
EGFR mutation
|
Tagrisso (osimertinib) • erlotinib • megestrol