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Metastatic Castration-Resistant Prostate Cancer (mCRPC)Phase 2NCT03712930

Treatment of Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency

A Phase 2 study testing Pamiparib in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Homologous Recombination Deficiency (HRD), run by BeiGene at 9 sites in 4 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This study is designed to evaluate the efficacy of pamiparib in participants with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). All participants will receive pamiparib. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
Pamiparib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
9 sitesin 4 countries
Study dates
5 Feb 2019to 2 Sep 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men (≥ 18 years of age) with histologically or cytologically confirmed adenocarcinoma or poorly differentiated adenocarcinoma of the prostate without neuroendocrine differentiation with HRD deficiency by CTC-HRD assay and/or deleterious germline or somatic mutation in BRCA1 or BRCA2; mCRPC measurable disease and/or bone disease. • PSA progression with ≥ 3 rising PSA levels with ≥ 1 week between determinations and a screening PSA ≥ 2 μg/L (2 ng/mL).
  • Must be surgically or medically castrated with serum testosterone levels of ≤1.73 nmol/L (50 ng/dL), must have received ≥ 1 prior androgen receptor-targeted therapy, and must have received ≥ 1 taxane-based therapy.
  • mCRPC with 1 or 2 of the following:
  • Measurable disease per RECIST v1.1
  • Bone disease
  • CTC-HRD+ or BRCA1/2 mutation
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  • PSA progression (PCWG3 criteria)
  • ≥1 androgen receptor-targeted therapy (eg, abiraterone acetate/prednisone or enzalutamide) for mCRPC with progressive disease
  • ≥1 taxane for metastatic prostate cancer

Who cannot join

  • Chemotherapy, hormonal therapy, biologic therapy, radionuclide therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or herbal remedies ≤ 5 half-lives if the half-life is known, ≤ 14 days if not known, before start of study treatment
  • Continued treatment with a bisphosphonate or denosumab is allowed, if administered at a stable dose > 28 days before start of study treatment
  • Radiotherapy ≤ 21 days (≤ 14 days, if single fraction of radiotherapy) before start of study treatment
  • Prior treatment for prostate cancer with any of the following:
  • poly ADP ribose polymerase (PARP) inhibitor
  • Platinum
Show all 9Show fewer
  • Cyclophosphamide
  • Mitoxantrone
  • NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

9 sites in 4 countries.

9 sites in 4 countries

Australia4 sites

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Icon Cancer Care Foundation

    South Brisbane, Queensland, 044101

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

Other trials in Australia

United States3 sites

  • University Cancer and Blood Center

    Athens, Georgia, 30607

  • University of Washington

    Seattle, Washington, 98195

  • Montefiore Einstein Cancer Center

    The Bronx, New York, 10461

Other trials in United States

Puerto Rico1 site

  • Pan American Oncology Trials, LLC

    Rio Piedras, 935

Other trials in Puerto Rico

Spain1 site

  • L Hospitalet de Llobregat

    Barcelona, 8035

Other trials in Spain

About this study

Official title: A Phase 2, Open-Label, Single-Arm Study of BGB-290 (BGB-290) for the Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC) With Homologous Recombination Deficiency (HRD)

This study is designed to evaluate the efficacy of pamiparib in participants with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). All participants will receive pamiparib. The purpose of this study is to demonstrate that pamiparib will improve Objective Response Rate (ORR) and Prostate-Specific Antigen (PSA) response rate

Read the detailed description

This is a global, Phase 2, open-label study of pamiparib in approximately 100 participants with metastatic castration-resistant prostate cancer (mCRPC) positive for circulating tumor cells (CTC) with homologous recombination deficiency (CTC-HRD). Participants in Cohort 1 will include 50 mCRPC participants with CTC-HRD-positive, measurable metastatic disease (soft tissue with/without bone lesions), and positive BRCA1/2 mutation or negative/unknown BRCA1/2 mutation. Cohort 2 will include 30 mCRPC CTC-HRD positive participants with bone metastasis only and positive or negative/unknown BRCA1/2. Cohort 3 and 4 will include 20 mCRPC CTC-HRD negative/unknown participants with BRCA1/2 positive mutations, metastatic disease (measurable soft tissue with/without bone), and bone only. Participants will undergo PSA level assessments approximately every 4 weeks as well as tumor assessments every 8 weeks for 24 weeks and the every 12 weeks, or as clinically indicated. Administration of pamiparib will continue until disease progression, unacceptable toxicity, death or another discontinuation criterion is met.

Being tested
Pamiparib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PamiparibDrug

    Also called BGB-290

    60 mg orally twice daily (BID)

Study groups in NCT03712930
Study groupRoleWhat they receive
PamiparibExperimentalParticipants will receive pamiparib for a period up to 1 year
Receives: Drug: Pamiparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) Determined by Independent Review Committee

    ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by an Independent Review Committee (IRC).

    Measured: Up to 1 year and 6 months

  2. Prostate-Specific Antigen (PSA) Response Rate

    PSA response rate is defined as the percentage of participants with PSA decline ≥ 50% from baseline [confirmed by a second PSA value ≥ 3 weeks later] for CTC-HRD-positive participants with or without measurable disease.

    Measured: Up to 1 year and 6 months

Secondary outcomes (11)

  1. Duration of Response (DOR) by IRC

    DOR is defined as the time from the date of the earliest documented CR or PR (that is subsequently confirmed) to radiographic disease progression or death due to any cause, whichever occurs first.

    Measured: Up to 1 year and 7 months

  2. Objective Response Rate by Investigator

    ORR is the percentage of participants with a best objective response of complete response (CR) or partial response (PR) confirmed at a subsequent timepoint ≥ 4 weeks later by the investigator.

    Measured: Up to 1 year and 6 months

  3. Time to Objective Response by Investigator

    Time to objective response is defined as the time from the date of the first dose of study drug to the first documented confirmed response of CR or PR assessed by the investigator and summarized for participants who have achieved a confirmed objective response.

    Measured: Up to 1 year and 6 months

  4. Clinical Benefit Rate By Investigator

    Clinical Benefit Rate is the percentage of participants who achieved confirmed CR, PR, or SD or NON-CR/NON-PD. The minimum interval for confirmed CR and PR is 4 weeks and the measurement of SD or NON-CR/NON-PD is 7 weeks after first dose date.

    Measured: Up to 1 year and 6 months

  5. Time to PSA Response

    Time to PSA response is defined as the time from the date of the first dose of study drug to the first PSA decline ≥ 50% that is subsequently confirmed. Assessments are summarized for participants who have achieved a confirmed PSA response.

    Measured: Up to 1 year and 6 months

  6. Duration of PSA Response

    Duration of PSA response is defined as the time from the date of the earliest documented PSA response (that is subsequently confirmed) to PSA progression or death due to any cause, whichever occurs first. PSA progression is defined as a ≥ 25% increase in PSA with an absolute increase of ≥ 2 μg/L above the nadir (or above the baseline for participants with no PSA decline) after12 weeks, confirmed by a second value ≥ 3 weeks later. The nadir is defined as the lowest value at or after baseline.

    Measured: Up to 1 year and 7 months

  7. Time to PSA Progression

    Time to PSA progression is defined as the time from the date of the first dose of study drug to a ≥ 25% increase in PSA with an absolute increase of ≥ 2 ng/mL above the nadir (or above the baseline for participants with no PSA decline) after 12 weeks, confirmed by a second value ≥ 3 weeks later. Death for the participants with no PSA progression is also considered as an event.

    Measured: Up to 1 year and 7 months

  8. Time to Symptomatic Skeletal Event

    Time to symptomatic skeletal event (SSE) is defined as time from the date of the first dose of study drug to the first symptomatic fracture, radiation or surgery to bone, or spinal cord compression.

    Measured: Up to 1 year and 7 months

  9. Radiographic Progression-Free Survival by IRC

    Radiographic progression-free survival is defined as the time from the date of the first dose of study drug to radiographic disease progression by IRC or death due to any cause, whichever occurs first.

    Measured: Up to 1 year and 7 months

  10. Overall Survival (OS)

    Overall survival is defined as the time from the date of the first dose of study drug to death due to any cause.

    Measured: Up to 1 year and 7 months

  11. Number of Participants With Treatment-Emergent Adverse Events Graded According to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03

    Measured: From the date of first Pamiparib dose until 30 days after the last dose or initiation of new anti-cancer therapy, whichever occurs first. (Up to 1 year and 7 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2018
  2. Study start5 Feb 2019
  3. Primary completion6 Aug 2020
  4. Study completion2 Sep 2020

Why it stopped: Sponsor's decision to revisit the development approach for prostate cancer.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03712930
Sponsor's protocol ID
BGB-290-202
Other IDs
2018-002587-28, 2018
Status last verified
Oct 2021
First submitted
11 Oct 2018
Last updated
17 Nov 2021
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pamiparib in people with Metastatic Castration-Resistant Prostate Cancer (mCRPC) and Homologous Recombination Deficiency (HRD), run by BeiGene at 9 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Australia, United States, Puerto Rico, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Determined by Independent Review Committee (time frame: Up to 1 year and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03712930.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2021.

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