Efficacy, Safety, and Pharmacokinetics of FP-014, 22.5 mg in Patients With Advanced Prostate Cancer

NCT06795191 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: FP014C-24-002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a study in male patients with advanced prostate cancer who are eligible for androgen ablation therapy. The study duration will be up to 48 weeks. Eligibility will be assessed during a screening period of up to 28 days. Up to 2 doses of a long-acting FP-014, 22.5 mg formulation will be given to the patients by separate SC injections 24 weeks apart in an unblinded manner. The first dose of FP-014, 22.5 mg will be administered on Day 0 (Visit 2/Week 1). When patients have tolerated the first dose of FP-014, 22.5 mg and have achieved castrate levels of serum testosterone, a second dose will be administered on Day 168 (Visit 14/Week 24) to achieve castrate levels of serum testosterone concentrations (\< 50 ng/dL). Patients will be followed for efficacy, safety, tolerability, and ancillary clinical and laboratory markers for an additional 24-week observation period (Day 336/Week 48/ Visit 24) Blood samples will be collected at Baseline (Day 0/Week 1) at least 30 minutes before the first FP-014, 22.5 mg administration, immediately thereafter and at specified time points through Day 336 (Week 48) to determine PK (triptorelin) and pharmacodynamics (PD) (testosterone, PSA, and LH) profiles.

Conditions

Prostate Cancer

Keywords

Prostate cancer

Outcome Measures

Primary Outcomes (2)

• Primary Endpoints

  The percentage of patients with a serum testosterone concentration suppressed to castrate levels (\< 50 ng/dL).

  Baseline to Week 4 (Day 28 ± 1 day) following the first SC injection of FP-014 (22.5 mg).

• Primary Endpoints

  The percentage of patients with serum testosterone concentration suppressed to castrate levels (\< 50 ng/dL)

  from Week 4 (Day 28 ± 1 day) through Week 48 (Day 336 ± 5 days).

Secondary Outcomes (7)

• Secondary Endpoints

  From injection through 48-72 hours after the second injection of FP-014, 22.5 mg

• Secondary Endpoints

  Baseline to Week 48/End of Study (EOS) (Day 336 ± 5 days).

• Secondary Endpoints

  Baseline to Week 48/EOS (Day 336 ± 5 days)

• Secondary Endpoints

  Week 48/EOS (Day 336 ± 5 days)

• Secondary Endpoints

  Week 48/EOS (Day 336 ± 5 days)

Study Arms (1)

FP-014

EXPERIMENTAL

Each patient will receive 2 single doses of FP-014, 22.5 mg administered as SC injections. The two injections of the study drug will be administered 24 weeks apart; one injection at Baseline (Visit 2/Day 0/Week 1), and one at Visit 14 (Day 168/Week 24) to achieve castrate serum testosterone level (\< 50 ng/dL).

Drug: Triptorelin Mesylate

Interventions

Triptorelin Mesylate DRUG

22.5 mg in a prefilled, ready-to-use, long-acting formulation

FP-014

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged ≥ 18 years old at Screening.
• Histologically confirmed carcinoma of the prostate at the time of Screening.
• Metastatic or biochemically recurrent prostate cancer disease at Screening.
• Patient agrees to use male contraceptive methods during the study.
• In the Investigator's opinion, the patient understands the nature of the study and any hazards of participation, communicates satisfactorily with the Investigator, and is able to participate in and comply with the requirements of the entire protocol.
• Patients judged by the attending physician and/or Principal Investigator to be a candidate for androgen ablation therapy.
• Patients who are able to tolerate ablation therapy but are considered unable to tolerate androgen receptor pathway inhibitors.
• ECOG Performance Status score ≤ 2 and life expectancy of at least 18 months at Screening.
• Baseline morning serum testosterone level \> 150 ng/dL at Screening.
• Laboratory values at Screening:
• Absolute neutrophil count ≥ 1,500 cells/μL;
• Platelets ≥ 100,000 cells/μL;
• Hemoglobin ≥ 10 gm/dL;
• Total bilirubin ≤ 1.5 × upper limit of normal (ULN);
• AST ≤ 2.5 × ULN;

You may not qualify if:

• Receipt of chemotherapy, immunotherapy, cryotherapy, radiotherapy, or anti- androgen therapy within 8 weeks prior to Screening, for treatment of carcinoma of the prostate.
• Receipt of any luteinizing hormone-releasing hormone (LH-RH) suppressive therapy within 6 months of the Screening Visit.
• Receipt of any vaccination (including influenza) within 2 weeks of the Screening Visit.
• History of blood donation within 2 months of the Screening Visit.
• History of anaphylaxis to any LH-RH analogues.
• Contraindication to triptorelin or an LH-RH agonist as indicated on the package labeling.
• Previous exposure to triptorelin mesylate.
• Major surgery, including any prostatic surgery (excluding prostatic biopsy), within 4 weeks of the Screening Visit.
• History of bilateral orchiectomy, adrenalectomy, or hypophysectomy.
• History of clinical and radiographic evidence of central nervous system dysfunction.
• Spinal cord metastases and patients at risk for spinal cord compression.
• Clinical evidence of uncontrolled active urinary tract obstruction and patients at risk for urinary obstruction.
• Clinically significant abnormal ECG at Screening and/or history of clinically significant ECG.
• Cardiovascular disease that is clinically significant as judged by the Investigator.
• History of Uncontrolled diabetes, HbA1C \>9.5%, urine glycosuria \>1.0 g/dl, or presence of diabetic ketoacidosis.

Sponsors & Collaborators

• Foresee Pharmaceuticals Co., Ltd.: lead
• QPS Holdings LLC: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Susan Whitaker, BSN, MS, MBA

  Foresee Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 27, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): January 2, 2028
• Last Updated: April 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share