Advanced Solid TumorPhase 1NCT04322552
A Pharmacokinetic Interaction Study Between Apatinib Mesylate and Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects
A Phase 1 study testing Apatinib Mesylate and Digoxin tablet in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial summary
Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2#VEGFR-2#, Induces Transporter Pgp function in vitro. This study in patients with advanced cancer evaluated the effect of Apatinib on Transporter Pgp function by comparing the pharmacokinetics of Transporter Pgp-specific probe drugs in the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- Apatinib Mesylate and Digoxin tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 12 Mar 2020to 3 May 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histologically or cytologically confirmed diagnosis of advanced solid tumors. 2. ECOG PS score: 0-1; 3. Expected survival ≥ 3 months; 4. Major organs must function normally, meeting the following criteria:
- Hematology
- HB≥100 g/L;
- ANC≥1.5×109/L;
- PLT≥90×109/L;
- Blood biochemistry:
Show all 12Show fewer
- TBIL≤ 1.25×ULN;
- ALT and AST≤2.5×ULN;
- ALP≤2.5×ULN;
- Serum Cr ≤ 1.5 × ULN or endogenous CrCl ≥ 60 mL/min (Cockcroft-Gault formula);
- Albumin > 30 g/L;
- K+>3.0mmol/L; 5. Able to understand and sign an informed consent form (ICF).
Who cannot join
- Primary liver cancer; gastric cancer;
- Active brain metastasis (medically uncontrolled), carcinomatous meningitis, spinal cord compression;
- Presence of clinically symptomatic third space fluid;
- Uncontrolled hypertension (SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg despite optimal pharmacological treatment);
- Uncontrolled clinically significant heart disease, including but not limited to the following: (1) >2 NYHA 2 congestive heart failure; (2) left ventricular ejection fraction (LVEF) < 50% (3) heart rate <60 (4) Grade II or greater myocardial ischemia or myocardial infarction(5) QTc interval ≥ 450 ms in males and ≥ 470 ms in females;
- Abnormal coagulation function;
Show all 12Show fewer
- Prior radiotherapy, systemic chemotherapy (< 6 weeks if chemotherapy including nitrosoureas or mitomycin), hormone therapy, surgery or target therapy within 4 weeks before the study drug administration, or any unresolved AEs > CTC-AE Grade 1;
- History of psychotropic substance abuse, alcoholism or drug abuse;
- Use of study drugs in other clinical trials within 4 weeks prior to the first dose；
- Use of a potent CYP3A4 inhibitor or inducer within 2 weeks prior to the first dose;
- Use of any prescription or over-the-counter medication, vitamin products or herbs within 2 weeks before taking the investigational drug;
- Other factors that may lead to the termination of the participation in the study at the discretion of the investigators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Apatinib Mesylate on Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects
Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2#VEGFR-2#, Induces Transporter Pgp function in vitro. This study in patients with advanced cancer evaluated the effect of Apatinib on Transporter Pgp function by comparing the pharmacokinetics of Transporter Pgp-specific probe drugs in the presence and absence of Apatinib. The probes used Substrate Digoxin.
- Conditions
- Advanced Solid Tumor
- Being tested
- Apatinib Mesylate, Digoxin tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib MesylateDrug
Apatinib at a dosage of will be administered daily from on D5 through D16
Digoxin tabletDrug
Digoxin at a dosage of 0.25mg will be administered at day 1 and day 12
| Study group | Role | What they receive |
|---|---|---|
| Treament | Experimental | In phase A, subjects receiving a single 0.25 mg of digoxin orally and wash-out for 5 days, then apatinib once daily will be conducted on D5 through D16 ； In addition, a single dose of 0.25 mg digoxin (in combination with apatinib) will be orally administered in fasting conditions on D12； Receives: Drug: Apatinib Mesylate; Drug: Digoxin tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics parameter: Cmax of digoxin
Peak Plasma Concentration (Cmax) of digoxin
Measured: through study completion, an average of 16 days
Pharmacokinetics parameter: AUC of digoxin
Area under the plasma concentration versus time curve (AUC) of digoxin
Measured: through study completion, an average of 16 days
Secondary outcomes (5)
Pharmacokinetics parameter: Tmax of digoxin
Time of maximum observed concentration (Tmax) of digoxin
Measured: through study completion, an average of 16 days
Pharmacokinetics parameter: T1/2 of digoxin
Half time (T1/2) of digoxin
Measured: through study completion, an average of 16 days
Pharmacokinetic parameters CL/F of digoxin
Total body clearance for extravascular administration (CL/F) of digoxin
Measured: through study completion, an average of 16 days
Pharmacokinetics parameter: Vz/F of digoxin
Volume of distribution (Vz/F) of digoxin
Measured: through study completion, an average of 16 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
An adverse event is any untoward medical occurrence in a patient or clinical study participant criteria
Measured: through study completion, an average of 16 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start12 Mar 2020
- Primary completion3 Apr 2021
- Study completion3 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322552
- Sponsor's protocol ID
- HR-APTN-I-007
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm, Open and Fixed Sequence Study to Investigate the Pharmacokinetic Effects of Apatinib Mesylate on Transporter Pgp Substrate Digoxin in Advanced Solid Tumor Subjects
- ClinicalTrials.gov ID
- NCT04322552
- Acronym / sponsor ID
- HR-APTN-I-007
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2020 (actual)
- Primary completion
- 3 Apr 2021 (actual)
- Study completion
- 3 May 2021 (actual)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Apatinib, an oral inhibitor of vascular endothelial growth factor receptor 2#VEGFR-2#, Induces Transporter Pgp function in vitro. This study in patients with advanced cancer evaluated the effect of Apatinib on Transporter Pgp function by comparing the pharmacokinetics of Transporter Pgp-specific probe drugs in the presence and absence of Apatinib. The probes used Substrate Digoxin.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treament | Experimental | Drug: Apatinib Mesylate, Drug: Digoxin tabletIn phase A, subjects receiving a single 0.25 mg of digoxin orally and wash-out for 5 days, then apatinib once daily will be conducted on D5 through D16 ； In addition, a single dose of 0.25 mg digoxin (in combination with apatinib) will be orally administered in fasting conditions on D12； |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Histologically or cytologically confirmed diagnosis of advanced solid tumors. 2. ECOG PS score: 0-1; 3. Expected survival ≥ 3 months; 4. Major organs must function normally, meeting the following criteria:
- Hematology
- Blood biochemistry:
Key exclusion criteria (12 listed)
- Primary liver cancer; gastric cancer;
- Active brain metastasis (medically uncontrolled), carcinomatous meningitis, spinal cord compression;
- Presence of clinically symptomatic third space fluid;
- Uncontrolled hypertension (SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg despite optimal pharmacological treatment);
- Uncontrolled clinically significant heart disease, including but not limited to the following: (1) >2 NYHA 2 congestive heart failure; (2) left ventricular ejection fraction (LVEF) < 50% (3) heart rate <60 (4) Grade II or greater myocardial ischemia or myocardial infarction(5) QTc interval ≥ 450 ms in males and ≥ 470 ms in females;
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 |
|---|---|---|
| Apatinib MesylateApatinib at a dosage of will be administered daily from on D5 through D16 | Drug | Treament |
| Digoxin tabletDigoxin at a dosage of 0.25mg will be administered at day 1 and day 12 | Drug | Treament |
Primary outcome
Pharmacokinetics parameter: Cmax of digoxin
Time frame: through study completion, an average of 16 days
Peak Plasma Concentration (Cmax) of digoxin
Pharmacokinetics parameter: AUC of digoxin
Time frame: through study completion, an average of 16 days
Area under the plasma concentration versus time curve (AUC) of digoxin
5 secondary outcomes
Pharmacokinetics parameter: Tmax of digoxin
Time frame: through study completion, an average of 16 days
Pharmacokinetics parameter: T1/2 of digoxin
Time frame: through study completion, an average of 16 days
Pharmacokinetic parameters CL/F of digoxin
Time frame: through study completion, an average of 16 days
Pharmacokinetics parameter: Vz/F of digoxin
Time frame: through study completion, an average of 16 days
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: through study completion, an average of 16 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Advanced Solid Tumor
Not yet recruitingPhase 1
A Study of Mesothelin-Targeted CAR-Mix Cells in Patients With Advanced Solid Tumors
Mesothelin-Positive Advanced Solid Tumors With Peritoneal Metastasis
RecruitingPhase 1/2
A Study of Bispecific Antibody MCLA-158 in Patients With Advanced Solid Tumors
Advanced/Metastatic Solid Tumors, Colorectal Cancer
RecruitingPhase 2
A Study of Navlimetostat (BMS-986504) Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
Solid Tumors
RecruitingPhase 1
Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Advanced Solid Tumors
RecruitingPhase 1/2
CR-002 in Adult Participants With Locally Advanced or Metastatic Solid Tumors
Head and Neck Squamous Cell Carcinoma (HNSCC) - Recurrent/Metastatic (R/M), Gastric/GEJ
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Apatinib Mesylate and Digoxin tablet in people with Advanced Solid Tumor, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
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 12 inclusion and 12 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 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Pharmacokinetics parameter: Cmax of digoxin (time frame: through study completion, an average of 16 days). 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?
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 7 Nov 2022.