deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT02614859

Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients (BIMET-1)

Bicalutamide With or Without Metformin for Biochemical Recurrence in Overweight or Obese Prostate Cancer Patients (BIMET-1)

Sponsor: Fox Chase Cancer Center

Updated 11 times since 2017 Last updated: Mar 2, 2022 Started: Dec 1, 2015 Primary completion: Jan 24, 2020 Completion: Jan 24, 2020
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02614859, this PHASE2 trial focuses on Cancer of Prostate and remains completed. Sponsored by Fox Chase Cancer Center, it has been updated 11 times since 2015, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Study Description(click to expand)

1 Cycle = 28 days = 4 weeks. Treatment will be administered on an outpatient basis ӿ Metformin starting dose is 500 mg BID, will be gradually increased to target dose of 1000mg BID. Treatment ARM A Cycles 1 - 2: Observation without treatment Cycles 3 - 8: Bicalutamide 50 mg daily, orally, continuously to the end of study (week 32). Treatment ARM B Cycles 1 - 2: In order to minimize gastrointestinal discomfort, metformin dosing will be ramped up over a period of 2 weeks. Metformin treatment will be started at 500 mg BID (Dose Level -2) and increased by an increment of 500 mg daily every week +/- 2 days provided no grade 2 or higher gastrointestinal toxicity is noted. If grade 2 or greater gastrointestinal toxicity occurs during the first 4 weeks of treatment, the subject will be evaluated every 2 weeks until resolution of toxicity to grade 0 or 1 and, then, the metformin dose will be increased to the next dose level. The target dose of metformin is 1000 mg BID.

1 Cycle = 28 days = 4 weeks. Treatment will be administered on an outpatient basis ӿ Metformin starting dose is 500 mg BID, will be gradually increased to target dose of 1000mg BID.

Treatment ARM A Cycles 1 - 2: Observation without treatment Cycles 3 - 8: Bicalutamide 50 mg daily, orally, continuously to the end of study (week 32).

Treatment ARM B Cycles 1 - 2: In order to minimize gastrointestinal discomfort, metformin dosing will be ramped up over a period of 2 weeks. Metformin treatment will be started at 500 mg BID (Dose Level -2) and increased by an increment of 500 mg daily every week +/- 2 days provided no grade 2 or higher gastrointestinal toxicity is noted. If grade 2 or greater gastrointestinal toxicity occurs during the first 4 weeks of treatment, the subject will be evaluated every 2 weeks until resolution of toxicity to grade 0 or 1 and, then, the metformin dose will be increased to the next dose level. The target dose of metformin is 1000 mg BID.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotRecruiting~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotRecruiting~Jun 2018 – ~Aug 2019 · 14 months · monthly snapshotRecruiting~Aug 2019 – ~Jun 2020 · 10 months · monthly snapshotRecruiting~Jun 2020 – ~Sep 2020 · 3 months · monthly snapshotRecruiting~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Apr 2022 · 15 months · monthly snapshotActive Not Recruiting~Apr 2022 – ~Jul 2024 · 27 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Apr 2022 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not RecruitingCompleted

  5. Jan 2021 — Apr 2022 [monthly]

    Active Not Recruiting PHASE2

Show 6 earlier versions
  1. Sep 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE2

    Status: RecruitingActive Not Recruiting

  2. Jun 2020 — Sep 2020 [monthly]

    Recruiting PHASE2

  3. Aug 2019 — Jun 2020 [monthly]

    Recruiting PHASE2

  4. Jun 2018 — Aug 2019 [monthly]

    Recruiting PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Recruiting PHASE2

  6. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE2

    First recorded

Dec 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fox Chase Cancer Center
Data source: Fox Chase Cancer Center

For direct contact, visit the study record on ClinicalTrials.gov .