Advanced Solid TumorsPhase 1NCT03991494

Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-Pamiparib in Participants With Advanced Cancer

A Phase 1 study testing [14C]-pamiparib in people with Advanced Solid Tumors, run by BeiGene at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is an open-label study, in participants with advanced and/or metastatic solid tumors, which consists of 2 parts: a research phase (inpatient) and a treatment phase. The research phase (Part 1) of the study will assess the disposition of a single oral dose of [14C]-pamiparib. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Advanced Solid Tumors
What is being tested?: [14C]-pamiparib
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 2 sitesUnited Kingdom
Study dates: 29 May 2019to 5 Aug 2020
Phase: Phase 1
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
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically and/or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with approved therapies for which there are no standard therapies available
A total body weight between 50 and 100 kg, inclusive at Screening
Measurable disease by CT/MRI
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Adequate organ function

Who cannot join

Clinically significant cardiovascular disease
Have a previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome.
Poor peripheral venous access
Major surgical procedure, open biopsy, or significant traumatic injury ≤ 2 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
Use or have anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

The Clatterbridge Cancer Centre NHS Foundation Trust
Bebington, Wirral, CH63 4JY
Royal Liverpool University Hospital Clinical Research Unit
Liverpool

Other trials in United Kingdom

About this study

Official title: A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Pamiparib Following Single Oral Dose Administration in Patients With Advanced and/or Metastatic Solid Tumors

Conditions: Advanced Solid Tumors
Being tested: [14C]-pamiparib

What participants receive

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

[14C]-pamiparibDrug
During the treatment phase, pamiparib 60 mg administered orally twice daily

Study groups in NCT03991494
Study group	Role	What they receive
Pamiparib	Experimental	Not described Receives: Drug: [14C]-pamiparib

What is being measured

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

Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of Pamiparib
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F)
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total Radioactivity
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total Radioactivity
Measured: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Percentage of Total Radioactivity Excreted in Urine
Measured: 192 hours of [14C]-Pamiparib Administration
Cumulative Urinary Excretion of Pamiparib
Measured: 192 hours of [14C]-Pamiparib Administration
Renal Clearance of Pamiparib (CLR)
Measured: 192 hours of [14C]-Pamiparib Administration
Fecal Recovery of Total Radioactivity
Measured: 192 hours of [14C]-Pamiparib Administration
Cumulative Recovery of Total Radioactivity in Total Excreta
Measured: 192 hours of [14C]-Pamiparib Administration

Secondary outcomes (4)

Number of Participants With Treatment Emergent Adverse Events in Part1 and Part 2
Measured: Up to 6 months
Number of Participants With Clinically Significant Laboratory Abnormalities
Measured: Up to 6 months
Number of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight Data
Measured: Up to 6 months
Pamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3)
Human plasma, urine, and feces samples were analyzed by LC-MS.
Measured: 0.5, 1, 2, 6, 12, 24, 48, 72, 96, 120, and 144 hours post dose on Days 1 to 7

Timeline

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

29 May 20195 Aug 2020

First posted19 Jun 2019
Study start29 May 2019
Primary completion21 Oct 2019
Study completion5 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
More trials run by BeiGeneThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03991494
Sponsor's protocol ID: BGB-290-106
Other IDs: 2018-001156-36, 2018
Status last verified: Aug 2021
First submitted: 14 Jun 2019
Last updated: 27 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Publications

Mu S, Palmer D, Fitzgerald R, Andreu-Vieyra C, Zhang H, Tang Z, Su D, Sahasranaman S. Human Mass Balance and Metabolite Profiling of [14 C]-Pamiparib, a Poly (ADP-Ribose) Polymerase Inhibitor, in Patients With Advanced Cancer. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1108-1120. doi: 10.1002/cpdd.943. Epub 2021 Apr 19.
PubMed 33876576

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

All Advanced Solid Tumors trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1 Study to Investigate the Absorption, Metabolism, and Excretion of [14C]Pamiparib Following Single Oral Dose Administration in Patients With Advanced and/or Metastatic Solid Tumors
ClinicalTrials.gov ID: NCT03991494
Acronym / sponsor ID: BGB-290-106
Conditions: Advanced Solid Tumors
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 4 participants (actual)
Lead sponsor: BeiGeneIndustry (pharma, biotech, devices)
Study start: 29 May 2019 (actual)
Primary completion: 21 Oct 2019 (actual)
Study completion: 5 Aug 2020 (actual)
First posted: 19 Jun 2019 (actual)
Results: Posted 27 Sep 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pamiparib	Experimental	Drug: [14C]-pamiparib

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Histologically and/or cytologically confirmed advanced or metastatic solid tumor that has progressed after treatment with approved therapies for which there are no standard therapies available
A total body weight between 50 and 100 kg, inclusive at Screening
Measurable disease by CT/MRI
Eastern Cooperative Oncology Group (ECOG) performance status of ≤1
Adequate organ function

Key exclusion criteria (6 listed)

Clinically significant cardiovascular disease
Have a previous complete gastric resection, chronic diarrhea, active inflammatory gastrointestinal disease, or any other disease causing malabsorption syndrome.
Poor peripheral venous access
Major surgical procedure, open biopsy, or significant traumatic injury ≤ 2 weeks prior to Day 1, or anticipation of need for major surgical procedure during the course of the study
Use or have anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
[14C]-pamiparibDuring the treatment phase, pamiparib 60 mg administered orally twice daily	Drug	Pamiparib

Primary outcome

Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Maximum Observed Concentration (Cmax) of Pamiparib
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Maximum Observed Concentration (Cmax)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Time of Cmax (Tmax)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity Whole Blood Total Radioactivity Pharmacokinetics: Time of Cmax (Tmax)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: Apparent Terminal Elimination Half-Life (t1/2)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Apparent Total Clearance (CL/F)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: Apparent Volume of Distribution (Vz/F)
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pamiparib Pharmacokinetics: AUC0-∞ of Plasma Pamiparib Relative to AUC0-∞ of Plasma Total Radioactivity
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Plasma Pharmacokinetics: AUC0-∞ of Whole Blood Total Radioactivity to AUC0-∞ of Plasma Total Radioactivity
Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7
Percentage of Total Radioactivity Excreted in Urine
Time frame: 192 hours of [14C]-Pamiparib Administration
Cumulative Urinary Excretion of Pamiparib
Time frame: 192 hours of [14C]-Pamiparib Administration
Renal Clearance of Pamiparib (CLR)
Time frame: 192 hours of [14C]-Pamiparib Administration
Fecal Recovery of Total Radioactivity
Time frame: 192 hours of [14C]-Pamiparib Administration
Cumulative Recovery of Total Radioactivity in Total Excreta
Time frame: 192 hours of [14C]-Pamiparib Administration

4 secondary outcomes

Number of Participants With Treatment Emergent Adverse Events in Part1 and Part 2
Time frame: Up to 6 months
Number of Participants With Clinically Significant Laboratory Abnormalities
Time frame: Up to 6 months
Number of Participants With Clinically Significant Abnormalities in 12-lead ECG Parameters, Vital Signs Data, Physical Examinations and Weight Data
Time frame: Up to 6 months
Pamiparib Metabolite Identified and Metabolic Profile Using Measured Mass (M3)
Time frame: 0.5, 1, 2, 6, 12, 24, 48, 72, 96, 120, and 144 hours post dose on Days 1 to 7

Results and safety

Results posted to the registry on 27 Sep 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pamiparib	4	0

Primary outcome: Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7. Geometric mean (Geometric Coefficient of Variation). Unit: hours*nanograms/milliLiter (h*ng/mL)

Measure	Pamiparib n = 4
Value	29300 (21.6)

Population analysed: The PK population included all participants who received one dose of \[14C\]-pamiparib and had evaluable PK data.

Primary outcome: Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to Infinity (AUC0-∞)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7. Geometric mean (Geometric Coefficient of Variation). Unit: h*ngEq/g

Measure	Pamiparib n = 4
Plasma Total Radioactivity	42200 (21.5)
Whole Blood Total Radioactivity	32200 (16.2)

Population analysed: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

Primary outcome: Plasma Pamiparib Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC0-t)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7. Geometric mean (Geometric Coefficient of Variation). Unit: h*ng/mL

Measure	Pamiparib n = 4
Value	29200 (21.6)

Population analysed: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

Primary outcome: Plasma Total Radioactivity and Whole Blood Total Radioactivity Pharmacokinetics: AUC From Time Zero to the Last Quantifiable Concentration (AUC-t)

Time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7. Geometric mean (Geometric Coefficient of Variation). Unit: h*ngEq/g

Measure	Pamiparib n = 4
Plasma Total Radioactivity	41800 (21.6)
Whole Blood Total Radioactivity	31200 (16.1)

Population analysed: The PK population included all participants who received at least on dose of \[14C\]-pamiparib and had evaluable PK data.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Approximately 30 days after the last dose of pamiparib - up to 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pamiparib	0 of 4 (0%)	4 of 4 (100%)	0 of 4

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33876576Mu S, Palmer D, Fitzgerald R, Andreu-Vieyra C, Zhang H, Tang Z, Su D, Sahasranaman S. Human Mass Balance and Metabolite Profiling of [14 C]-Pamiparib, a Poly (ADP-Ribose) Polymerase Inhibitor, in Patients With Advanced Cancer. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1108-1120. doi: 10.1002/cpdd.943. Epub 2021 Apr 19.
Individual participant dataSharing planned: Yes

Related trials for Advanced Solid Tumors

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Study Director principal investigator

BeiGene

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-pamiparib in people with Advanced Solid Tumors, run by BeiGene at 2 sites in United Kingdom.

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 5 inclusion and 6 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: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 27 Sep 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?

Plasma Pamiparib Pharmacokinetics: Area Under the Concentration-time Curve (AUC) From Time Zero to Infinity (AUC0-∞) (time frame: Pre-dose and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 6, 12, 24, 48, 72, 96, 120, and 144 hours post-dose on Day 1 to Day 7). The study lists 19 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 NCT03991494, which also lists 1 linked publication.

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 27 Sep 2021.