Efficacy and Safety of Avatrombopag in Cancer Patients With Thrombocytopenia

NCT04896528 | Unknown Phase 2

• 1 other identifier: SKX-CIT-002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Thrombocytopenia; Avatrombopag

Outcome Measures

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.

  one year

Secondary Outcomes (4)

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

  one year

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

  one year

• Percentage of subjects without platelet transfusion within 20 days of treatment;

  one year

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

  one year

Study Arms (1)

Avatrombopag

EXPERIMENTAL

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

Avatrombopag DRUG

* 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.

Avatrombopag

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each participant must meet all of the following criteria:
• Male or female, 18\~85 years of age;
• Diagnosis of malignant solid tumor;
• 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);
• 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.
• ECGO performance status ≤2;
• Blood test:
• Hemoglobin (Hb) ≥ 9.0 g/dL;
• Absolute neutrophils count (ANC) ≥ 1,500/μL;
• 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)
• Participants able to oral medication;

You may not qualify if:

• Participants meeting any of the following criteria will be excluded from the study:
• 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;
• Participants finished major operation within less than 28 days and for minor operation within less than 3 days;
• Participants had clinically significant acute or active bleeding (e.g., gastrointestinal or central nervous system) within 7 days prior to screening;
• Participants has medical-known hereditary prethrombotic syndrome (such as factor V Leiden mutation, prothrombin G20210A mutation or hereditary antithrombin III deficiency);
• Participants has a history of arterial or venous thrombosis within 3 months prior to screening;
• Participants had treatment with heparin and warfarin within 7 days prior to screening;
• 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);
• Participants had the treatment of platelet transfusion within 3 days before enrollment;
• 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;
• Participants' thrombocytopenia responded effectively to hormone therapy;
• Participants are allergic to Avatrombopag or any of its excipients;
• Participants were in any other clinical trial of investigational product or device within 30 days prior to screening, except for observational study;
• 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;
• 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)

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (8)

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  PMID: 32295834 BACKGROUND

• 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.

  PMID: 17825602 RESULT

• 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.

  PMID: 12506176 RESULT

• 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.

  PMID: 19446902 RESULT

• 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.

  PMID: 10758304 RESULT

• 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.

  PMID: 15254053 RESULT

• 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.

  PMID: 27688097 RESULT

• 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.

  PMID: 24613543 RESULT

MeSH Terms

Conditions

Thrombocytopenia

Interventions

avatrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Study Officials

• Haitao Haitao, Prof

  Peking Union Medical College Hospital (PUMCH)

  STUDY CHAIR

Central Study Contacts

Yanyu Wang, MD

CONTACT

+86 15810784518; pumcwyy950105@163.com

Haitao Haitao, Prof

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients 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); Patients experienced grade III or above thrombocytopenia (PC ≤50×109/L) at least once within 48 h of the screening period;

Study Record Dates

• First Submitted: April 28, 2021
• First Posted: May 21, 2021
• Study Start: June 6, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 21, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)