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Status unknownNCT04896528Updated May 21, 2021

Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia

A Phase 2 interventional study of Avatrombopag in Thrombocytopenia and Avatrombopag, sponsored by Peking Union Medical College Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-05-21.

Sponsored by Peking Union Medical College Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2021), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 85 Years
Sex
All
01

Study summary

To evaluate the efficacy and safety of Avatrombopag in patients with thrombocytopenia induced by targeted therapy and immunotherapy combination treatment, and provide evidence-based medication for the clinical use of Avatrombopag in patients with PC ≤50×109/L

Read the detailed description

This phase II trial is a single-arm, non-randomized and single-center clinical study.

It is estimated that 30 patients who met the study criteria will be enrolled in PUMCH and treated with Avatrombopag. The investigators will follow up and collect subjects' data each month to evaluate the efficacy and safety of treatment. Primary outcome measure is percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment.

Secondary outcome measure:1)Number of days required for PLT to reach ≥50×109/L after treatment; 2)Number of days required for PLT to reach ≥75×109/L after treatment; 3)Percentage of subjects without platelet transfusion within 20 days of treatment; 4)Percentage of subjects without clinically relevant bleeding within 20 days of treatment.

Study Type: Interventional. Masking: Open Label.

02

Conditions studied

  • Thrombocytopenia
  • Avatrombopag

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03

In context

Thrombocytopenia

697 studies on the registry are indexed under Thrombocytopenia; 153 are open to participants now.

This study's planned enrollment of 30 is below the median of 55 across 472 interventional studies indexed under Thrombocytopenia.

Browse Thrombocytopenia studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Each participant must meet all of the following criteria:

  1. Male or female, 18\~85 years of age;
  2. Diagnosis of malignant solid tumor;
  3. Participants receiving combined targeted therapy (including but not limited to tyrosine kinase inhibitors, cyclin-dependent kinase inhibitors) with immunotherapy (including but not limited to PD-1 inhibitors and/or PD-L1 inhibitors and/or CTLA-4 inhibitors);
  4. Participants experienced grade III or above thrombocytopenia (PC ≤50×109/L) at least once within 48 h of the screening period; No oral platelet-enhancing drugs were given before enrollmen.
  5. ECGO performance status ≤2;

  6. Blood test:

    • Hemoglobin (Hb) ≥ 9.0 g/dL;
    • Absolute neutrophils count (ANC) ≥ 1,500/μL;

  7. Liver and renal functions:

    • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3*ULN (Upper Limits of Normal);
    • Serum bilirubin ≤ 1.5*ULN;
    • Albumin ≥ 2.5 g/dL;
    • Serum creatinine ≤ 1.5*ULN (CTCAE Grade Ⅰ)
  8. Participants able to oral medication;
  9. Expected survival time ≥12 weeks during screening period;
  10. Participants with negative urine or serum pregnancy test during screening period; fertile potential participants must agree to use contraception for the whole study period and 30 days after discontinuity of investigational product treatment (infertile potential was defined as the condition including hysterectomy and bilateral oophorectomy, bilateral salpingectomy, tubal ligation and postmenopausal);
  11. Participants in the trial is voluntary and must strictly abide by the protocol;
  12. Participants must sign the written informed consent form.

Exclusion criteria

Exclusion Criteria:

Participants meeting any of the following criteria will be excluded from the study:

  1. Participants has any history of active congestive heart failure [New York Heart Association (NYHA) Grade III-IV], symptomatic ischemia, uncontrolled arrhythmia, pericardial disease, or myocardial infarction during the first 4 months of enrollment;
  2. Participants finished major operation within less than 28 days and for minor operation within less than 3 days;
  3. Participants had clinically significant acute or active bleeding (e.g., gastrointestinal or central nervous system) within 7 days prior to screening;
  4. Participants has medical-known hereditary prethrombotic syndrome (such as factor V Leiden mutation, prothrombin G20210A mutation or hereditary antithrombin III deficiency);
  5. Participants has a history of arterial or venous thrombosis within 3 months prior to screening;
  6. Participants had treatment with heparin and warfarin within 7 days prior to screening;
  7. Participants has history of chronic thrombocytopenia or hemorrhagic disease, or thrombocytopenia induced by other reasons besides targeted therapy and immunotherapy combination treatment(e.g., chronic liver disease or immune thrombocytopenic purpura);
  8. Participants had the treatment of platelet transfusion within 3 days before enrollment;
  9. Participants had administration of platelet growth factor (e.g., rhTPO, rhIL-11, Eltrombopag, or Romiplostim) for the treatment of thrombocytopenia induced by targeted therapy and immunotherapy combination treatment within 2 weeks prior to screening;
  10. Participants' thrombocytopenia responded effectively to hormone therapy;
  11. Participants are allergic to Avatrombopag or any of its excipients;
  12. Participants were in any other clinical trial of investigational product or device within 30 days prior to screening, except for observational study;
  13. Participants have any known concomitant history that may impair the safe completion of the study as assessed by the investigator, such as unstable angina, renal failure due to hemodialysis, or active infection requiring intravenous antibiotics;
  14. Participants are pregnant or lactating at the time of screening (as demonstrated by a positive serum β-HCG test) or baseline visit (positive urine β-HCG test)
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Avatrombopag

    Avartripopa is a new generation of oral TPO receptor agonist that simulates the biological effects of TPO in vitro and in vivo. TPO stimulates megakaryocytes through binding and activation of TPO receptor, which is expressed in hematopoietic stem cells, megakaryotic cell lines and platelets. By binding to the transmembrane region of the thrombopoietin receptor, Ava Tripopa activates the thrombopoietin receptor in humans, stimulates signal transduction and mimics the biological effects of thrombopoietin, leading to an increase in platelet count.

    Drug: Avatrombopag

Interventions

  • DrugAvatrombopag

    * Participants meeting the eligibility criteria receive Avatrombopag treatment (orally, 60 mg/day), for a maximum course of 20 days. * Investigation product withdrawal: PLT ≥75×109/L or increases by at least 50×109/L from the lowest value after targeted therapy and immunotherapy combination treatment.

06

What researchers measure

Primary outcomes

  1. Percentage of participants' PLT

    Percentage of participants whose PLT reaches ≥75×109/L, or increases by ≥50×109/L or ≥100% from baseline at least once within 20 days of initial treatment.

    Time frame: one year

Secondary outcomes

  1. Number of days required for PLT to reach ≥50×109/L after treatment;

    Time frame: one year

  2. Number of days required for PLT to reach ≥75×109/L after treatment;

    Time frame: one year

  3. Percentage of subjects without platelet transfusion within 20 days of treatment;

    Time frame: one year

  4. Percentage of subjects without clinically relevant bleeding within 20 days of treatment.

    Time frame: one year

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing 100730, China
    Recruiting
08

References and documents

Publications

  • Arora S, Balasubramaniam S, Zhang W, Zhang L, Sridhara R, Spillman D, Mathai JP, Scott B, Golding SJ, Coory M, Pazdur R, Beaver JA. FDA Approval Summary: Pembrolizumab plus Lenvatinib for Endometrial Carcinoma, a Collaborative International Review under Project Orbis. Clin Cancer Res. 2020 Oct 1;26(19):5062-5067. doi: 10.1158/1078-0432.CCR-19-3979. Epub 2020 Apr 15. PubMed 32295834 ↗
  • Lingen MW, Kalmar JR, Karrison T, Speight PM. Critical evaluation of diagnostic aids for the detection of oral cancer. Oral Oncol. 2008 Jan;44(1):10-22. doi: 10.1016/j.oraloncology.2007.06.011. Epub 2007 Sep 6. PubMed 17825602 ↗
  • Adelstein DJ, Li Y, Adams GL, Wagner H Jr, Kish JA, Ensley JF, Schuller DE, Forastiere AA. An intergroup phase III comparison of standard radiation therapy and two schedules of concurrent chemoradiotherapy in patients with unresectable squamous cell head and neck cancer. J Clin Oncol. 2003 Jan 1;21(1):92-8. doi: 10.1200/JCO.2003.01.008. PubMed 12506176 ↗
  • Pignon JP, le Maitre A, Maillard E, Bourhis J; MACH-NC Collaborative Group. Meta-analysis of chemotherapy in head and neck cancer (MACH-NC): an update on 93 randomised trials and 17,346 patients. Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14. PubMed 19446902 ↗
  • Suntharalingam M, Haas ML, Conley BA, Egorin MJ, Levy S, Sivasailam S, Herman JM, Jacobs MC, Gray WC, Ord RA, Aisner JA, Van Echo DA. The use of carboplatin and paclitaxel with daily radiotherapy in patients with locally advanced squamous cell carcinomas of the head and neck. Int J Radiat Oncol Biol Phys. 2000 Apr 1;47(1):49-56. doi: 10.1016/s0360-3016(00)00408-9. PubMed 10758304 ↗
  • Garden AS, Harris J, Vokes EE, Forastiere AA, Ridge JA, Jones C, Horwitz EM, Glisson BS, Nabell L, Cooper JS, Demas W, Gore E. Preliminary results of Radiation Therapy Oncology Group 97-03: a randomized phase ii trial of concurrent radiation and chemotherapy for advanced squamous cell carcinomas of the head and neck. J Clin Oncol. 2004 Jul 15;22(14):2856-64. doi: 10.1200/JCO.2004.12.012. PubMed 15254053 ↗
  • Adkins D, Ley J, Michel L, Wildes TM, Thorstad W, Gay HA, Daly M, Rich J, Paniello R, Uppaluri R, Jackson R, Trinkaus K, Nussenbaum B. nab-Paclitaxel, cisplatin, and 5-fluorouracil followed by concurrent cisplatin and radiation for head and neck squamous cell carcinoma. Oral Oncol. 2016 Oct;61:1-7. doi: 10.1016/j.oraloncology.2016.07.015. Epub 2016 Jul 29. PubMed 27688097 ↗
  • Reddy BK, Lokesh V, Vidyasagar MS, Shenoy K, Babu KG, Shenoy A, Naveen T, Joseph B, Bonanthaya R, Nanjundappa, Bapsy PP, Loknatha, Shetty J, Prasad K, Tanvir Pasha CR. Nimotuzumab provides survival benefit to patients with inoperable advanced squamous cell carcinoma of the head and neck: a randomized, open-label, phase IIb, 5-year study in Indian patients. Oral Oncol. 2014 May;50(5):498-505. doi: 10.1016/j.oraloncology.2013.11.008. Epub 2014 Mar 6. PubMed 24613543 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 21, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04896528
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Sponsor
First posted
May 21, 2021
Start date
Jun 6, 2021 (estimated)
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
May 21, 2021

Study contacts

Yanyu Wang, MD
Contact
pumcwyy950105@163.com
+86 15810784518
Haitao Haitao, Prof
Contact
Haitao Haitao, Prof
study chair · Peking Union Medical College Hospital (PUMCH)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.

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