Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor

NCT03299452 | Unknown Phase 2 DMC

• 1 other identifier: Alphacait 001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Conditions

Metastatic Cancer

Keywords

ex vivo high-throughput drug screening assay

Outcome Measures

Primary Outcomes (1)

• Progression-free survival(PFS)

  Progression-free survival (PFS) is defined as the time from assignment in the trial to disease progression or death from any cause.

  36 months

Secondary Outcomes (5)

• Overall survival(OS)

  36 months

• Overall response rate (ORR)

  36 months

• Disease control rate(DCR)

  36 months

• Incidence of Treatment-Emergent Adverse Events

  36 months

• Biomarkers

  36months

Study Arms (1)

Alphacait-guided therapy

EXPERIMENTAL

Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines until the patient progresses, intolerant, the patient withdrawn or the investigator determines that the medication must be discontinued.

Drug: Non Chemotherapy; Drug: Chemotherapy and target therapy; Drug: Chinese herb medicine

Interventions

Non Chemotherapy DRUG

Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.

Alphacait-guided therapy

Chemotherapy and target therapy DRUG

Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.

Alphacait-guided therapy

Chinese herb medicine DRUG

Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.

Alphacait-guided therapy

Eligibility Criteria

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

You may qualify if:

• Advanced recurrent or metastatic malignant tumor confirmed by pathological diagnosis;
• At least one measurable malignant lesion;
• Failed previous standard treatment or with tumor recurrence, and no standard therapeutic regimen available;
• No radiation therapy within last four weeks or recovered from last radiation related acute complication, if applicable; prophylactic brain radiation therapy or palliative radiation treatment for bone metastasis is acceptable;
• No gender requirement and must be no younger than18 years old;
• ECOG PS: score 0-2;
• Life expectancy more than three months;
• Patient's organ function level should meet these criteria:
• (1) CBC should meet these criteria: ANC≥1.5×109 /L，PLT≥100×109/L，Hb≥ 100 g/L; (2) Chemistry should meet these criteria: TBIL\<1.5×ULN，ALT、AST\< 2.5×ULN（if with liver metastasis ALT、AST\<5×ULN） BUN and Cr ≤1×ULN or Cr clearance ≥50ml/min（Cockcroft-Gault formula） 9. Agree to use appropriate contraceptive measure during the study period and until 8 weeks after the last study drug is given. Or patient has been surgically sterilized.
• \. Qualified candidate should voluntarily participate this study, sign informed consent forms and be compliant with the study protocols and follow-up visit(s).

You may not qualify if:

• Symptomatic brain metastasis (could still enroll into the study if treatment finished 21 days prior to the enrollment and the patient is stable, but brain MRI, CT or angiogram is needed to rule out no intracranial hemorrhage)
• Following cardiac disease: second-degree or above cardiac ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval male\>450 ms, female\>470ms), according to NYHA criteria, III to IV cardiac insufficiency, or echocardiogram reveals left ventricular ejection fraction (LVEF) \<50%;
• History of pulmonary interstitial lung disease or active interstitial lung disease;
• Coagulation dysfunction (INR \>1.5 or PT\>ULN+ 4sec, or PTT\>1.5 ULN), with bleeding tendency or currently receiving thrombolysis therapy or anticoagulation treatment;
• Clinical bleeding episode or bleeding tendency within past three months, such as GI bleeding, hemorrhagic gastric ulcer, stool guaiac++ positive, or with vasculitis；
• Arterial or venous thrombosis within last 12 months, such as various types of CVA, DVT or PE patients;
• Known hereditary or acquired bleeding or hypercoagulable state (such as hemophilia, coagulating dysfunction, thrombocytopenia, hypersplenism);
• Major surgery, trauma, fracture or ulcer within past 4 weeks;
• Active infection requiring antibiotics, antifungal or antiviral treatment;
• Patient has a history of psychiatric medication abuse and cannot be abstinent from the psychiatric medication, or with mental disorder;
• Participation of other cancer chemotherapy clinical study within past 4 weeks;
• History of uncured coexisting cancer, no including cured basal cell carcinoma, cervical cancer in situ, or superficial bladder cancer;
• Pregnant or breast feeding women; fertile patients no willing or able to take effective contraceptive measures;
• Any circumstances that might affect the proceeding of the clinical trial and/or research result analysis, as determined by the clinical investigator(s).

Sponsors & Collaborators

• Haining Health-Coming Biotech Co., Ltd.: lead
• Alphacait, LLC: collaborator

Study Sites (1)

Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Haizhou Lou, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Linghua Zhu, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

• Enguo Chen, MD

  Sir Run Run Shaw Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bin Li, MD

CONTACT

86-137-50766911; yanfangren1019@gmail.com

Haizhou Lou, MD

CONTACT

86-571-86006926; louhz09@aliyun.com

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: This single center, open-label, single arm, non-randomized study is designed to evaluate safety, progression-free survival(PFS),overall survival (OS), objective response rate (OPR), and disease control rate (DCR) of chemotherapy or target therapy or chinese medicine based on the Alphacait screening system in subjects with advanced malignant tumor.

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: October 3, 2017
• Study Start: January 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12/31/2018

Locations

CN (1)