Trial of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer (mCRPC)
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| ClinicalTrials.gov Identifier: NCT03888612 |
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Recruitment Status :
Recruiting
First Posted : March 25, 2019
Last Update Posted : February 6, 2023
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Sponsor:
Arvinas Androgen Receptor, Inc.
Information provided by (Responsible Party):
Arvinas Inc. ( Arvinas Androgen Receptor, Inc. )
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Brief Summary:
Phase 1/2 dose escalation study to assess the safety and tolerability of ARV-110 in men with mCRPC who have progressed on prior approved systemic therapies for their castrate resistant disease (one of which must be enzalutamide or abiraterone).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer Metastatic | Drug: ARV-110 | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 250 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2, Open-label, Dose Escalation, and Cohort Expansion Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ARV-110 in Patients With Metastatic Castration Resistant Prostate Cancer |
| Actual Study Start Date : | March 1, 2019 |
| Estimated Primary Completion Date : | February 28, 2023 |
| Estimated Study Completion Date : | October 31, 2023 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Prostate cancer
MedlinePlus related topics:
Prostate Cancer
| Arm | Intervention/treatment |
|---|---|
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Experimental: ARV-110
Part A: Oral tablet(s), once or twice daily in 28 day cycles Part B: Oral tablet(s), once or twice daily in 28 day cycles |
Drug: ARV-110
Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A |
Primary Outcome Measures :
- Part A: Incidence of Dose Limiting Toxicities of ARV-110 [ Time Frame: 28 Days ]First Cycle Dose limiting toxicities characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug
- Part A: Number of Patients with Adverse Events as a measure of safety and tolerability of ARV-110 [ Time Frame: 28 Days ]Adverse events as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), timing, seriousness, and relationship to study drug.
- Part A: Incidence of laboratory abnormalities as a measure of safety and tolerability of ARV-110 [ Time Frame: 28 Days ]Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE version 5.0), and timing.
- Part B: Measurement of PSA response rate per PCWG3 accessing anti-tumor activity of ARV-110 [ Time Frame: 12 Weeks ]PSA response rate per PCWG3.
- Part B: Measurement of overall RECIST response rate accessing the anti-tumor activity of ARV-110 [ Time Frame: 12 Weeks ]Overall RECIST response rate in patients with measurable disease at baseline.
- Part B: To evaluate the clinical anti-tumor activity of ARV-110 in patients with mCRPC [ Time Frame: 12 Weeks ]To evaluate the clinical anti-tumor activity (PSA response rate per PCWG3, Overall RECIST RR, rPFS, and PFS) of ARV-110 in patients with mCRPC in different subgroups of patients with mCRPC with predefined tumor genomic and molecular profiles or based on prior therapy.
Secondary Outcome Measures :
- Part A: Anti-tumor activity based on the overall PSA response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor. [ Time Frame: 12 Weeks ]The anti-tumor activity of ARV-110 will be assessed by evaluating the overall PSA response per PCWG3.
- Part A: Anti-tumor activity based on the overall RECIST response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor. [ Time Frame: 12 Weeks ]The anti-tumor activity of ARV-110 will be assessed by evaluating the overall RECIST response rate.
- Part A: Anti-tumor activity based on the progression free survival in the entire study population and in the subsets of patient based on the AR mutational status of their tumor. [ Time Frame: 12 Weeks ]The anti-tumor activity of ARV-110 will be assessed by evaluating the time to event progression free survival.
- Part A: Anti-tumor activity based on the duration of response in the entire study population and in the subsets of patient based on the AR mutational status of their tumor. [ Time Frame: 12 Weeks ]The anti-tumor activity of ARV-110 will be assessed by evaluating the duration of response.
- Part A: Anti-tumor activity based on the time to progression in the entire study population and in the subsets of patient based on the AR mutational status of their tumor. [ Time Frame: 12 Weeks ]The anti-tumor activity of ARV-110 will be assessed by evaluating the time to progression.
- Part A: Anti-tumor activity based on the overall survival in the entire study population and in the subsets of patient based on the AR mutational status of their tumor. [ Time Frame: 12 Weeks ]The anti-tumor activity of ARV-110 will be assessed by evaluating the overall survival.
- Part A: Concentration-time curve (AUC) for single and multiple dose of ARV-110 [ Time Frame: 28 Days ]PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).
- Part A: Maximum concentration (Cmax) for single and multiple dose of ARV-110 [ Time Frame: 28 Days ]PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter maximum concentration (Cmax).
- Part A: Minimum concentration (Cmin) for single and multiple dose of ARV-110 [ Time Frame: 28 Days ]PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter minimum concentration (Cmin).
- Part A: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110 [ Time Frame: 28 Days ]PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
- Part B: Concentration-time curve (AUC) for single and multiple dose of ARV-110 [ Time Frame: 28 Days ]PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter area under the concentration-time curve (AUC).
- Part B: Maximum concentration (Cmax) for single and multiple dose of ARV-110 [ Time Frame: 28 Days ]PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter maximum concentration (Cmax).
- Part B: Minimum concentration (Cmin) for single and multiple dose of ARV-110 [ Time Frame: 28 Days ]PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter minimum concentration (Cmin).
- Part B: Time to maximum concentration (Tmax) for single and multiple dose of ARV-110 [ Time Frame: 28 Days ]PK parameters will be assessed when applicable after a single dose and after multiple once and twice daily doses. Assessment of pharmacokinetic parameter time to maximum concentration (Tmax)
- Part B: Duration of response [ Time Frame: 12 Weeks ]From the date of first confirmed best overall response of CR or PR to the date of first progression per RECIST 1.1 or PCWG3, or death due to any cause without evidence of radiographic progression, whichever occurs first.
- Part B: Overall survival [ Time Frame: 12 Weeks ]Time interval from the date of first ARV-110 dose to the date of death due to any cause.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Part A:
- Patients must be male and at least 18 years of age at the time of signing the informed consent.
- Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate.
- Patients must have progressed on at least 2 prior approved systemic therapies for CRPC (at least one must be abiraterone or enzalutamide).
- Patients with progressive mCRPC
- Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
Part B:
- Patients must be male and at least 18 years of age at the time of signing the informed consent.
- Patients must present with histological, pathological, or cytological confirmed diagnosis of advanced or metastatic castration resistant adenocarcinoma of the prostate.
- Patients must have received at least one but no more than two prior second generation anti-androgen agents (e.g., enzalutamide or abiraterone) for CRPC.
- Patients must have received no more than one prior chemotherapy regimen in each of the following settings: castrate sensitive and castrate resistant prostate cancer.
- Patients must have ongoing ADT with a gonadotropin releasing hormone analog or inhibitor, or orchiectomy (surgical or medical castration).
Part B - Phase 2 Expansion Cohort Subgroup 4
- Patient has received only one prior AR second generation therapy (e.g., abiraterone or enzalutamide) either as treatment for CSPC or CRPC and no more than 1 regimen in CRPC setting.
- No prior chemotherapy
Exclusion Criteria:
Part A:
- Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses)
- Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
- Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study
- Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug.
Part B:
- Patients with known symptomatic brain metastases requiring steroids (above physiologic replacement doses)
- Major surgery (as defined by the Investigator) within 4 weeks of first dose of study drug.
- Radiation therapy within 4 weeks of first dose of study drug or prior irradiation to >25% of the bone marrow. Palliative radiation for the alleviation of pain due to bone metastasis will be allowed during the study
- Systemic anti cancer therapy within 2 weeks of first dose of study drug (6 weeks for bicalutamide, mitomycin C, or nitrosoureas and 4 weeks for abiraterone). Patients are ineligible if they received any other type of anti cancer agent (except agents to maintain castrate status) within 2 weeks before first dose of study drug.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03888612
Contacts
| Contact: Arvinas Androgen Receptor, Inc. | 475-345-3354 | clinicaltrialsARV-110@arvinas.com |
Locations
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Sponsors and Collaborators
Arvinas Androgen Receptor, Inc.
| Responsible Party: | Arvinas Androgen Receptor, Inc. |
| ClinicalTrials.gov Identifier: | NCT03888612 |
| Other Study ID Numbers: |
ARV-110-mCRPC-101 |
| First Posted: | March 25, 2019 Key Record Dates |
| Last Update Posted: | February 6, 2023 |
| Last Verified: | February 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Arvinas Inc. ( Arvinas Androgen Receptor, Inc. ):
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Metastatic Prostate Cancer Castrate-Resistant Prostate Cancer mCRPC adenocarcinoma of the prostate |
Additional relevant MeSH terms:
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms |
Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases |