Solid TumorPhase 1NCT03994211

Study to Investigate the Effect of Rifampin and Itraconazole on the Action of Pamiparib in Participants With Cancer

A Phase 1 study testing pamiparib 60 mg, pamiparib 20 mg and itraconazole in people with Solid Tumor, run by BeiGene at 4 sites in 4 countries.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor
What is being tested?: pamiparib 60 mg, pamiparib 20 mg and itraconazole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 4 sitesin 4 countries
Study dates: 29 May 2019to 6 Aug 2021
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

Age ≥ 18 years
Histologically or cytologically confirmed advanced or metastatic solid tumors that are refractory or resistant to standard therapy or for which no suitable effective standard therapy exists.
Disease that is evaluable per RECIST Version 1.1 or Prostate Cancer Working Group-3 (PCWG-3)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Life expectancy ≥ 12 weeks
Adequate hematologic and end-organ function

Who cannot join

History of hypersensitivity to rifampin, any rifamycin or any of the components of the rifampin capsule (Part A).
History of hypersensitivity to itraconazole or any of the components of the itraconazole capsule (Part B).
Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor at therapeutic doses is allowed, provided that such treatment was not the most recent therapy (PARP inhibitor must have been discontinued ≥ 3 months prior to the first dose of pamiparib):
Participants who experienced prior severe toxicity to PARP inhibitors that in the opinion of the investigator precludes further treatment with PARP inhibitors should be excluded
Diagnosis of Myelodysplastic syndrome (MDS)
Active infection requiring systemic treatment

Show all 21Show fewer

Any of the following cardiovascular criteria:
Cardiac chest pain, defined as moderate pain that limits instrumental activities of daily living, ≤ 28 days before Day 1 of pamiparib administration
Symptomatic pulmonary embolism ≤ 28 days before Day 1 of pamiparib administration
Any history of acute myocardial infarction ≤ 6 months before Day 1 of pamiparib administration
Any history of heart failure meeting New York Heart Association Classification III or IV ≤ 6 months before Day 1 of pamiparib
Participants with congestive heart failure or history of heart failure should be excluded from Part B (itraconazole)
Any event of ventricular arrhythmia ≥ Grade 2 in severity ≤ 6 months before Day 1 of pamiparib administration
Any history of cerebral vascular accident ≤ 6 months before Day 1 of pamiparib administration
Previous complete gastric resection or lap-band surgery, chronic diarrhea, active inflammatory gastrointestinal disease, known diverticular disease or any other disease-causing malabsorption syndrome
Gastroesophageal reflux disease under treatment with proton pump inhibitors is allowed
Active bleeding disorder, including gastrointestinal bleeding, as evidenced by hematemesis, significant hemoptysis, or melena ≤ 6 months before Day 1 of pamiparib administration
Use or anticipated need for food or drugs known to be strong or moderate CYP3A inhibitors or strong CYP3A inducers ≤ 14 days (or ≤ 5 half-lives if half-life is known) prior to Day 1 of pamiparib administration
Known history of intolerance to the excipients of the pamiparib capsule
Have known hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial locations and contacts

4 sites in 4 countries.

Country

City, postcode or hospital

4 sites in 4 countries

Georgia1 site

Arensia Exploratory Medicine Llc
Tbilisi, 0112

Other trials in Georgia

Moldova1 site

Republican Clinical Hospital, Oncology Department
Chiinu, 2025

Other trials in Moldova

Poland1 site

Szpital Luxmed
Warsaw, 02-801

Other trials in Poland

Slovakia1 site

Summit Clinical Research, Sro
Bratislava, 83101

Other trials in Slovakia

About this study

Official title: A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Pamiparib (BGB-290) in Cancer Patients

The study was an open-label, parallel-group, fixed-sequence study in male and female cancer patients. The study consists of 2 phases: the Core Phase, which is divided into Part A and Part B, and the Extension Phase. Part A investigated the effect of CYP3A induction by rifampin on the single dose pharmacokinetics (PK) of pamiparib, and Part B investigated the effect of CYP3A inhibition by itraconazole on the single dose PK of pamiparib. Participants were offered participation in the Extension Phase, in which they received pamiparib until progression of disease, unacceptable toxicity, withdrawal of consent, or any other reason for discontinuation.

Conditions: Solid Tumor
Being tested: pamiparib 60 mg, pamiparib 20 mg, itraconazole, rifampin, pamiparib

What participants receive

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

pamiparib 60 mgDrug
Single dose of 60 mg pamiparib orally on Days 1 and 10
pamiparib 20 mgDrug
Single dose of 20 mg pamiparib orally on days 1 and 7
itraconazoleDrug
200 mg itraconazole once a day al Day 3 to day 8
rifampinDrug
600 mg rifampin once a day from days 3 to 11
pamiparibDrug
60 mg pamiparib orally twice a day in 28-day cycles

Study groups in NCT03994211
Study group	Role	What they receive
Part A (core phase)	Experimental	60 mg pamiparib administered orally on Days 1 and 10 fasting 8 hours pre-dose 600 mg rifampin once a day from days 3 to 11 in the fasted state (at least 2 hours predose) Receives: Drug: pamiparib 60 mg; Drug: rifampin
Part B (core phase)	Experimental	Single dose of 20 mg pamiparib orally in the fasted state (at least 8 hours predose) on days 1 and 7 200 mg itraconazole once a day approximately 30 minutes after completing a meal Day 3 to day 8 Receives: Drug: pamiparib 20 mg; Drug: itraconazole
Extension phase	Experimental	60 mg pamiparib orally twice a day in 28-day cycles until progression of disease Receives: Drug: pamiparib

What is being measured

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

Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part A
Measured: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part B
Measured: Part B: from Day -1 (admission) to Day 9 (discharge; ) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part A
Measured: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part B
Measured: Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part A
Measured: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part B
Measured: Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part A
Measured: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose
AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part B
Measured: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose
AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part A
Measured: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose
AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part B
Measured: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose
Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part A
Measured: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part B
Measured: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part A
Measured: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part B
Measured: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part A
Measured: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part B
Measured: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part A
Measured: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part B
Measured: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

Secondary outcomes (2)

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
TEAE is defined as any AE with an onset date on or after the date of first dose of study medication until the date of last study medication dose plus 30 days. Seriousness of the AE is determined by the investigator based on seriousness criteria.
Measured: From the date informed consent has been signed until last study medication dose plus 30 days (up to approximately 26 months)
Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments, Vital Signs, ECG Parameters and Physical Examinations
Measured: Up to approximately 26 months

Timeline

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

29 May 20196 Aug 2021

First posted21 Jun 2019
Study start29 May 2019
Primary completion25 Oct 2019
Study completion6 Aug 2021

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 Solid TumorStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03994211
Sponsor's protocol ID: BGB-290-105
Other IDs: 2019-000112-28, 2019
Status last verified: Oct 2024
First submitted: 18 Jun 2019
Last updated: 26 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes

Publications

Mu S, Lin C, Skrzypczyk-Ostaszewicz A, Bulat I, Maglakelidze M, Skarbova V, Andreu-Vieyra C, Sahasranaman S. The pharmacokinetics of pamiparib in the presence of a strong CYP3A inhibitor (itraconazole) and strong CYP3A inducer (rifampin) in patients with solid tumors: an open-label, parallel-group phase 1 study. Cancer Chemother Pharmacol. 2021 Jul;88(1):81-88. doi: 10.1007/s00280-021-04253-x. Epub 2021 Mar 27.
PubMed 33772633

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

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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
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Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1, Open-label, Parallel-group, Fixed-sequence Study to Investigate the Effect of the CYP3A Inducer Rifampin and the CYP3A Inhibitor Itraconazole on the Pharmacokinetics of Pamiparib (BGB-290) in Cancer Patients
ClinicalTrials.gov ID: NCT03994211
Acronym / sponsor ID: BGB-290-105
Conditions: Solid Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: BeiGeneIndustry (pharma, biotech, devices)
Study start: 29 May 2019 (actual)
Primary completion: 25 Oct 2019 (actual)
Study completion: 6 Aug 2021 (actual)
First posted: 21 Jun 2019 (actual)
Results: Posted 23 May 2023

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Part A (core phase)	Experimental	Drug: pamiparib 60 mg, Drug: rifampin60 mg pamiparib administered orally on Days 1 and 10 fasting 8 hours pre-dose 600 mg rifampin once a day from days 3 to 11 in the fasted state (at least 2 hours predose)
Part B (core phase)	Experimental	Drug: pamiparib 20 mg, Drug: itraconazoleSingle dose of 20 mg pamiparib orally in the fasted state (at least 8 hours predose) on days 1 and 7 200 mg itraconazole once a day approximately 30 minutes after completing a meal Day 3 to day 8
Extension phase	Experimental	Drug: pamiparib60 mg pamiparib orally twice a day in 28-day cycles until progression of disease

Who may qualify

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

Key inclusion criteria (6 listed)

Age ≥ 18 years
Histologically or cytologically confirmed advanced or metastatic solid tumors that are refractory or resistant to standard therapy or for which no suitable effective standard therapy exists.
Disease that is evaluable per RECIST Version 1.1 or Prostate Cancer Working Group-3 (PCWG-3)
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Life expectancy ≥ 12 weeks

Key exclusion criteria (21 listed)

History of hypersensitivity to rifampin, any rifamycin or any of the components of the rifampin capsule (Part A).
History of hypersensitivity to itraconazole or any of the components of the itraconazole capsule (Part B).
Prior treatment with a poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor at therapeutic doses is allowed, provided that such treatment was not the most recent therapy (PARP inhibitor must have been discontinued ≥ 3 months prior to the first dose of pamiparib):
Diagnosis of Myelodysplastic syndrome (MDS)
Active infection requiring systemic treatment

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
pamiparib 60 mgSingle dose of 60 mg pamiparib orally on Days 1 and 10	Drug	Part A (core phase)
pamiparib 20 mgSingle dose of 20 mg pamiparib orally on days 1 and 7	Drug	Part B (core phase)
itraconazole200 mg itraconazole once a day al Day 3 to day 8	Drug	Part B (core phase)
rifampin600 mg rifampin once a day from days 3 to 11	Drug	Part A (core phase)
pamiparib60 mg pamiparib orally twice a day in 28-day cycles	Drug	Extension phase

Primary outcome

Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part A
Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part B
Time frame: Part B: from Day -1 (admission) to Day 9 (discharge; ) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part A
Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part B
Time frame: Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part A
Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Zero to Infinity (AUC0-inf) of Pamiparib in Plasma for Part B
Time frame: Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose
AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part A
Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose
AUC From Zero to 12 Hours (AUC0-12) of Pamiparib in Plasma for Part B
Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, and 12 hours post-dose
AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part A
Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose
AUC From Zero to 9 Hours (AUC0-9) of Pamiparib in Plasma for Part B
Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, and 9 hours post-dose
Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part A
Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Time of the Maximum Observed Concentration (Tmax) of Pamiparib for Part B
Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part A
Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Terminal Elimination Half-life (t1/2) of Pamiparib in Plasma for Part B
Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part A
Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Oral Clearance (CL/F) of Pamiparib in Plasma for Part B
Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part A
Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose
Apparent Volume of Distribution (Vz/F) of Pamiparib in Plasma for Part B
Time frame: Part B: from Day -1 (admission) to Day 9 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12 hours post-dose

2 secondary outcomes

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame: From the date informed consent has been signed until last study medication dose plus 30 days (up to approximately 26 months)
Number of Participants With Clinically Significant Abnormalities in Laboratory Assessments, Vital Signs, ECG Parameters and Physical Examinations
Time frame: Up to approximately 26 months

Results and safety

Results posted to the registry on 23 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Core Phase: Arm A: Pamiparib + Rifampin	12	12
Core Phase: Arm B: Pamiparib + Itraconazole	13	12
Extension Phase	0	0

Primary outcome: Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part A

Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose. Median (Full Range). Unit: ng/mL

Measure	Part A: Pamiparib n = 11	Part A: Pamiparib + Rifampin n = 11
Value	1970 (1060.0 to 2700.0)	1820 (1170.0 to 2500.0)

Part A: Pamiparib vs Part A: Pamiparib + Rifampin: Geometric Mean Ratio Estimate: 0.94 (90% CI 0.83 to 1.06)

Population analysed: The pharmacokinetic (PK) population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an adverse event (AE) of vomiting that occurred at or before 2 x median tmax.

Primary outcome: Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part B

Time frame: Part B: from Day -1 (admission) to Day 9 (discharge; ) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose. Median (Full Range). Unit: ng/mL

Measure	Part B: Pamiparib n = 12	Part B: Pamiparib + Itraconazole n = 12
Value	730.5 (374.0 to 1130.0)	752.5 (302.0 to 1130.0)

Part B: Pamiparib vs Part B: Pamiparib + Itraconazole: Geometric Mean Ratio: 1.05 (90% CI 0.95 to 1.15)

Primary outcome: AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part A

Time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose. Median (Full Range). Unit: hours*nanograms/milliLiter (h*ng/mL)

Measure	Part A: Pamiparib n = 11	Part A: Pamiparib + Rifampin n = 11
Value	28868 (14680.8 to 46910.6)	18351 (11097.3 to 24186.8)

Part A: Pamiparib vs Part A: Pamiparib + Rifampin: Geometric Mean Ratio: 0.62 (90% CI 0.54 to 0.70)

Population analysed: The PK population includes all participants who received at least 1 dose of pamiparib and have evaluable PK data. A participant was to be excluded from the PK summary statistics and statistical analysis if the participant had an AE of vomiting that occurred at or before 2 x median tmax.

Primary outcome: AUC From Time Zero to Time of Last Quantifiable Concentration Post-dose (AUC0-tlast) in Plasma for Part B

Time frame: Part B: from Day -1 (admission) to Day 9 (discharge) 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose. Median (Full Range). Unit: hours*nanograms/milliLiter (h*ng/mL)

Measure	Part B: Pamiparib n = 12	Part B: Pamiparib + Itraconazole n = 12
Value	9163 (1797.5 to 20891.1)	8894 (1528.1 to 19356.9)

Part B: Pamiparib vs Part B: Pamiparib + Itraconazole: Geometric Mean Ratio: 0.99 (90% CI 0.91 to 1.09)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the date informed consent has been signed until last study medication dose plus 30 days (up to approximately 26 months). Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Core Phase: Arm A: Pamiparib + Rifampin	0 of 12 (0%)	5 of 12 (41.7%)	0 of 12
Core Phase: Arm B: Pamiparib + Itraconazole	1 of 13 (7.7%)	6 of 13 (46.2%)	0 of 13
Extension Phase	2 of 24 (8.3%)	18 of 24 (75%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 33772633Mu S, Lin C, Skrzypczyk-Ostaszewicz A, Bulat I, Maglakelidze M, Skarbova V, Andreu-Vieyra C, Sahasranaman S. The pharmacokinetics of pamiparib in the presence of a strong CYP3A inhibitor (itraconazole) and strong CYP3A inducer (rifampin) in patients with solid tumors: an open-label, parallel-group phase 1 study. Cancer Chemother Pharmacol. 2021 Jul;88(1):81-88. doi: 10.1007/s00280-021-04253-x. Epub 2021 Mar 27.
Individual participant dataSharing planned: Yes

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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

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 study director

BeiGene

4 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing pamiparib 60 mg, pamiparib 20 mg and itraconazole in people with Solid Tumor, run by BeiGene at 4 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 6 inclusion and 21 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Georgia, Moldova, Poland, Slovakia. 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 23 May 2023). 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?

Maximum Observed Concentration (Cmax) of Pamiparib in Plasma for Part A (time frame: Part A: from Day -1 (admission) to Day 12 (discharge); 30 min pre-dose, 0.5, 1, 2, 4, 6, 9, 12, 24, and 48 hours post-dose). The study lists 18 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 NCT03994211, 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 26 Oct 2024.