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Last Updated: November 26, 2020

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CLINICAL TRIALS PROFILE FOR GOSERELIN ACETATE

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505(b)(2) Clinical Trials for Goserelin Acetate

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
New Formulation NCT04060043 Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer Completed Peptigroupe Inc Early Phase 1 2017-02-21 This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
New Formulation NCT04060043 Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer Completed CMX Research Early Phase 1 2017-02-21 This open-label study is designed to obtain preliminary data on the efficacy of a new depot formulation of goserelin, Pepti 10.8mg, in ambulatory patients with carcinoma of the prostate who, in the opinion of the Investigator, is a candidate for androgen deprivation therapy, after a single injection. Secondarily, it is designed to assess the pharmacokinetics, safety profile and PSA response of this new formulation.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Goserelin Acetate

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00002460 Adjuvant Hormone Therapy in Treating Women With Operable Breast Cancer Unknown status Cancer Research UK Phase 3 1987-09-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. PURPOSE: Phase III trial to compare the effectiveness of adjuvant therapy using tamoxifen or ovarian ablation with goserelin or both in treating women with stage I or stage II breast cancer.
NCT00002580 Tamoxifen, Ovarian Ablation, and/or Combination Chemotherapy in Treating Premenopausal Women With Stage I, Stage II, or Stage IIIA Invasive Breast Cancer Completed Scottish Cancer Therapy Network Phase 3 1993-06-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with hormone therapy may kill more tumor cells. It is not yet known which treatment regimen is most effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of ovarian ablation, and/or combination chemotherapy in treating premenopausal women with stage I, stage II, or stage IIIA breast cancer.
NCT00002582 Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer Completed Cancer Research Campaign Clinical Trials Centre Phase 3 1993-06-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.
NCT00002582 Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer Completed Scottish Cancer Therapy Network Phase 3 1993-06-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.
NCT00002582 Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer Completed Yorkshire Regional Clinical Trials Research Unit Phase 3 1993-06-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.
NCT00002582 Tamoxifen, Ovarian Ablation, and/or Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA Breast Cancer Completed Institute of Cancer Research, United Kingdom Phase 3 1993-06-01 RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen. Combination chemotherapy uses different ways to stop tumor cells from dividing so they stop growing or die. Combining hormone therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with or without chemotherapy and/or ovarian ablation in treating women with stage I, stage II, or stage IIIA breast cancer.
NCT00002597 Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer Completed National Cancer Institute (NCI) Phase 3 1994-10-01 RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Goserelin Acetate

Condition Name

Condition Name for Goserelin Acetate
Intervention Trials
Prostate Cancer 49
Breast Cancer 20
Prostate Adenocarcinoma 9
Stage III Prostate Cancer 7
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Condition MeSH

Condition MeSH for Goserelin Acetate
Intervention Trials
Prostatic Neoplasms 70
Breast Neoplasms 28
Adenocarcinoma 17
Recurrence 4
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Clinical Trial Locations for Goserelin Acetate

Trials by Country

Trials by Country for Goserelin Acetate
Location Trials
United States 584
Canada 69
United Kingdom 20
Australia 10
Germany 6
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Trials by US State

Trials by US State for Goserelin Acetate
Location Trials
Texas 21
Michigan 19
California 19
Washington 18
Illinois 18
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Clinical Trial Progress for Goserelin Acetate

Clinical Trial Phase

Clinical Trial Phase for Goserelin Acetate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 43
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Goserelin Acetate
Clinical Trial Phase Trials
Completed 38
Recruiting 20
Active, not recruiting 16
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Clinical Trial Sponsors for Goserelin Acetate

Sponsor Name

Sponsor Name for Goserelin Acetate
Sponsor Trials
National Cancer Institute (NCI) 49
Southwest Oncology Group 9
Radiation Therapy Oncology Group 8
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Sponsor Type

Sponsor Type for Goserelin Acetate
Sponsor Trials
Other 119
NIH 50
Industry 30
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