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Solid Tumor, AdultPhase 1NCT04428086

A Pharmacokinetic Interaction Study Between Apatinib and Rosuvastatin or Metformin in Solid Tumor Subjects.

A Phase 1 study testing Apatinib in arm1, Rosuvastatin and Apatinib in arm2 in people with Solid Tumor, Adult, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.

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

The primary objective of the study was to assess investigate the pharmacokinetic effects of Apatinib on Rosuvastatin or Metformin. The secondary objective of the study was to assess the safety of Apatinib alone or Rosuvastatin/Metformin alone or concomitant medication. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Solid Tumor, Adult
What is being tested?
Apatinib in arm1, Rosuvastatin and Apatinib in arm2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteChina
Study dates
27 Jul 2020to 22 Aug 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

  • Subjects must meet all of the following criteria to enter the study:
  • Age: 18-70 years old (Include both values);
  • Patients with histopathologically or cytologically confirmed advanced solid tumor(except primary gastrointestinal tumors or metastatic gastrointestinal tumors and primary hepatocellular tumors) , not necessary to have measurable lesions;
  • The standard systemic treatment plan for tumors is ineffective, or intolerable, or there is no recurrence and metastasis after adjuvant chemotherapy and radiotherapy after surgery;
  • ECOG PS score: 0-1;
  • Expected survival ≥ 3 months;
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  • Adverse reactions caused by the subject receiving other treatments have recovered (recovered to ≤ grade 1 according to NCI-CTCAE 5.0, except for hair loss), more than 4 weeks after receiving radiotherapy or surgery or receiving other cytotoxic drugs or cell growth inhibitor.
  • Major organs must function normally, meeting the following criteria:
  • Haematology (no blood transfusion or blood products within the last 14 days, not corrected with G-CSF or other hematopoietic colony-stimulating factors):
  • HB≥100 g/L;
  • ANC≥1.5×109/L;
  • PLT≥90×109/L;
  • Blood biochemistry:
  • 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;
  • Urine protein inspection:
  • Urinary routines suggest that urine protein <++. If urinary protein ≥ ++, the quantification of urinary protein in 24 hours should be ≤1.5 g;
  • Agree to abstinence or take effective contraception during the study and for at least 8 weeks after the last study drug administration
  • Sign the ICF voluntarily, have good compliance, corporate with follow-up visits, and follow the study requirements.

Who cannot join

  • Subjects meeting any one of the followings will be excluded in this study:
  • Patients with gastrointestinal diseases that affect the use or absorption of drugs, such as gastric cancer or intestinal cancer, unable to swallow, chronic diarrhea, intestinal obstruction, large stomach or total gastrectomy, or within 6 months before the first medication Patients with abdominal fistula, gastrointestinal perforation or abdominal abscess;
  • Active (without medical control) brain metastases, cancerous meningitis, spinal cord compression patients, or imaging CT or MRI examination at screening to find diseases of the brain or pia mater
  • Presence of clinically symptomatic third space fluid (e.g. large pleural fluid or ascites) that cannot be controlled by drainage or other methods;
  • Patients with hypertension, or patients with a history of hypertension
  • Patients with NYHA Class III-IV cardiac insufficiency or left ventricular ejection fraction (LVEF) < 50% by echocardiography; uncontrolled arrhythmias (QTc interval ≥ 450 ms in males and ≥ 470 ms in females);
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  • During the study period, patients should be used drugs that may lead to prolonged QTc interval (such as antiarrhythmic drugs, quinidine, disopyramide, procainamide, sotalol, amiodarone, etc.)
  • Patients with abnormal coagulation function (INR > 1.5 or prothrombin time (PT) > ULN + 4 s or APTT > 1.5 ULN)
  • Patients with clinically significant bleeding or clear bleeding tendency within 3 months prior to the first dose, such as coughing up blood, hemoptysis, GI bleeding, hemorrhagic gastric ulcer, or baseline fecal occult blood (FOB) ++ and above. Gastroscopy is required for patients with FOB (+) and no surgical resection of primary gastric tumor. In case of ulcerative gastric cancer, patients are not enrolled due to a risk of acute gastrointestinal hemorrhage;
  • Events of arterial/venous thrombosis within 6 months prior to the first dose, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, brain infarction), deep vein thrombosis, and pulmonary embolism;
  • Known hereditary or acquired hemorrhage and thrombophilia (such as hemophilia, coagulopathy, thrombocytopenia, hypersplenism, etc.);
  • Patients treated with anticoagulants or vitamin K antagonists such as warfarin, heparin or similar drugs;
  • Have undergone major surgery or with severe traumatic injury, fracture, or ulcer within 4 weeks prior to the first dose; There is no previous wound healing.
  • Use of study drugs in other clinical trials within 4 weeks prior to the first dose;
  • Drugs that is CYP3A inhibitor, or the transporter BCRP or MATE1 inhibitor, or drugs that affect gastric acid secretion, or Chinese herbal medicines within 2 weeks before the first dose; use the drug that is metabolic enzyme CYP3A inducer within 4 weeks before the first dose
  • Infectious disease screening (hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody and human immunodeficiency virus antibody) positive
  • History of immunodeficiency, with acquired, congenital immunodeficiency disease, or history of organ transplantation

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050035

Other trials in China

About this study

Official title: Open-Label, Fixed-Sequence Study in Solid Tumor Subjects to Investigate the Pharmacokinetic Interaction Between Apatinib and Transporter Substrates Rosuvastatin and Metformin.

The primary objective of the study was to assess investigate the pharmacokinetic effects of Apatinib on Rosuvastatin or Metformin.

The secondary objective of the study was to assess the safety of Apatinib alone or Rosuvastatin/Metformin alone or concomitant medication.

Being tested
Apatinib in arm1, Rosuvastatin, Apatinib in arm2, Metformin

What participants receive

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

  • Apatinib in arm1Drug

    Apatinib will be administered at a dose of 250 mg once daily from Day 4 to Day 9.

  • RosuvastatinDrug

    Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 7.

  • Apatinib in arm2Drug

    Apatinib will be administered at a dose of 250 mg once daily from Day 3 to Day 7.

  • MetforminDrug

    Metformin will be administered as a single oral 500 mg on Day 1 and Day 6.

Study groups in NCT04428086
Study groupRoleWhat they receive
Assess PK effects of Apatinib on RosuvastatinExperimentalParticipant will be administered a single oral dose of rosuvastatin 10 milligram (mg) on Day 1 and Day 7 and Apatinib at a dose of 250 mg once daily from Day 4 until Day 9.
Receives: Drug: Apatinib in arm1; Drug: Rosuvastatin
Assess PK effects of Apatinib on MetforminExperimentalParticipant will be administered a single oral dose of metformin 500 milligram (mg) on Day 1 and Day 6 and Apatinib at a dose of 250 mg once daily from Day 3 until Day 7.
Receives: Drug: Apatinib in arm2; Drug: Metformin

What is being measured

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

  1. Maximum Observed Plasma Concentration (Cmax)

    The Cmax is the maximum observed concentration

    Measured: Up to Day 10

  2. Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])

    The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.

    Measured: Up to Day 10

  3. Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time

    Measured: Up to Day 10

Secondary outcomes (1)

  1. 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 35 or 37 days in two groups.

Timeline

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

  1. First posted11 Jun 2020
  2. Study start27 Jul 2020
  3. Primary completion22 Aug 2021
  4. Study completion22 Aug 2021

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 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two arms Assignment
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04428086
Sponsor's protocol ID
HR-APTN-I-010
Status last verified
Jul 2022
First submitted
27 May 2020
Last updated
26 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Apatinib in arm1, Rosuvastatin and Apatinib in arm2 in people with Solid Tumor, Adult, 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 22 inclusion and 17 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 Jul 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?

Maximum Observed Plasma Concentration (Cmax) (time frame: Up to Day 10). The study lists 3 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 NCT04428086.

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 Jul 2022.

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