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NCT02197897: BCTamoxifen

Evaluation the Treatment of Tamoxifen of Low/Intermediate Risk Bladder Tumors

Completed Phase 2 Results posted Last updated 13 January 2021
What this trial tests

Phase 2 trial testing Tamoxifen Citrate in Bladder Cancer in 15 participants. Completed in 28 June 2019.

Timeline
1 April 2015
Primary endpoint
12 September 2017
28 June 2019

Quick facts

Lead sponsorBaylor College of Medicine
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date1 April 2015
Primary completion12 September 2017
Estimated completion28 June 2019
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Baylor College of Medicine

Who can join

21 and older, any sex, with Bladder Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Evaluate the Efficacy for Treatment of Low/Intermediate- Risk Bladder Tumors, Assessing for the Clinical Response of the Marker Lesion Primary · 2.5 years

Evaluate the efficacy of tamoxifen for treatment of low/intermediate-risk bladder tumors, utilizing the RECIST criteria combined with the final biopsy of the marker lesion or the bed of the lesion in case of a complete response

GroupValue95% CI
Tamoxifen13

Adverse events — posted to ClinicalTrials.gov

Time frame: Clinical toxicity evaluations (secondary aim 1d) were performed at the beginning (postoperative day 3), midway (postoperative week 6), and at completion of treatment (postoperative week 12), prior to the final resection of the marker lesion. A final assessment for toxicity was also performed 30 days after completion of therapy and definitive resection of the marker lesion.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tamoxifen
Serious: 0/13 (0%)
Deaths: 0/13
Other adverse events (28 terms — click to expand)

ReactionSystemTamoxifen
HematuriaBlood and lymphatic system disorders
Urinary Tract PainGastrointestinal disorders
Pain in ExtremityMusculoskeletal and connective tissue disorders
Thromboembolic eventCardiac disorders
AnemiaBlood and lymphatic system disorders
Edema limbsGeneral disorders
Non Cardiac Chest PainCardiac disorders
Platelet Count decreasedBlood and lymphatic system disorders
HypocalcemiaBlood and lymphatic system disorders
Urinary FrequencyRenal and urinary disorders
Flank PainMusculoskeletal and connective tissue disorders
HypertensionCardiac disorders
Sinus BradycardiaCardiac disorders
Sinus TachycardiaCardiac disorders
FatigueGeneral disorders
Blood Bilirubin IncreaseBlood and lymphatic system disorders
creatinine increaseBlood and lymphatic system disorders
Lymphocyte Count decreaseBlood and lymphatic system disorders
HyperkalemiaBlood and lymphatic system disorders
HypoalbuminemiaBlood and lymphatic system disorders
HypomagnesemiaBlood and lymphatic system disorders
HyponatremiaBlood and lymphatic system disorders
Eye DisordersEye disorders
Abdominal PainGeneral disorders
DepressionPsychiatric disorders
Erectile DysfunctionGeneral disorders
DyspeniaGeneral disorders
Rash Maculo- PapularSkin and subcutaneous tissue disorders

Data from ClinicalTrials.gov NCT02197897 adverse events section.

Sponsor's own description

Evaluate the treatment of tamoxifen of low/intermediate-risk bladder tumors

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Mitochondrial adaptation in cancer drug resistance: prevalence, mechanisms, and management.
    Jin P, Jiang J, Zhou L, Huang Z, et al · · 2022 · cited 180× · PMID 35851420 · DOI 10.1186/s13045-022-01313-4
  2. Effects of Androgen and Estrogen Receptor Signaling Pathways on Bladder Cancer Initiation and Progression.
    Godoy G, Gakis G, Smith CL, Fahmy O. · · 2016 · cited 41× · PMID 27376135 · DOI 10.3233/blc-160052
  3. Overcoming Glucocorticoid Resistance in Acute Lymphoblastic Leukemia: Repurposed Drugs Can Improve the Protocol.
    Olivas-Aguirre M, Torres-López L, Pottosin I, Dobrovinskaya O. · · 2021 · cited 34× · PMID 33777761 · DOI 10.3389/fonc.2021.617937
  4. The Role of Estrogen Receptors in Urothelial Cancer.
    Goto T, Miyamoto H. · · 2021 · cited 30× · PMID 33796076 · DOI 10.3389/fendo.2021.643870
  5. Summary and Recommendations from the National Cancer Institute's Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer.
    Lerner SP, Bajorin DF, Dinney CP, Efstathiou JA, et al · · 2016 · cited 26× · PMID 27376138 · DOI 10.3233/blc-160053
  6. Sex Hormone Receptor Signaling in Bladder Cancer: A Potential Target for Enhancing the Efficacy of Conventional Non-Surgical Therapy.
    Ide H, Miyamoto H. · · 2021 · cited 25× · PMID 34064926 · DOI 10.3390/cells10051169
  7. Current clinical trials in non-muscle invasive bladder cancer.
    Siddiqui MR, Grant C, Sanford T, Agarwal PK. · · 2017 · cited 24× · PMID 28778250 · DOI 10.1016/j.urolonc.2017.06.043
  8. Intravesical Therapy for Non-muscle Invasive Bladder Cancer-Current and Future Options in the Age of Bacillus Calmette-Guerin Shortage.
    Golla V, Lenis AT, Faiena I, Chamie K. · · 2019 · cited 17× · PMID 32071562

Verify or expand the search:

Other trials of Tamoxifen Citrate

Trials testing the same drug.

Other recruiting trials for Bladder Cancer

Currently open trials in the same condition.

Other Baylor College of Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02197897.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing