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Nab-PCE vs PC for MM After Failure of Anti-PD-1

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ClinicalTrials.gov Identifier: NCT03917069
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Jun GUO, Beijing Cancer Hospital

Brief Summary:

This is a randomized controlled clinical trial of nab-paclitaxel + carboplatin

  • Endostatin for advanced melanoma after failure of PD-1 therapy. The aim was to evaluate the efficacy and safety of nab-paclitaxel+carboplatin
  • endostatin versus combination of paclitaxel and carboplatin in patients with advanced melanoma after failure of PD-1 therapy.

Condition or disease Intervention/treatment Phase
Advanced Melanoma Drug: Chemotherapeutic Combinations Drug: chemotherapy Phase 2

Detailed Description:
The enrollment time is expected to be 1.5 year and the observation time is 2 years. The regimen were performed on a 28-day/21-day cycle respectively. Subjects who met the entry criteria were treated in a 2:1 group according to a randomized list: the treatment group was treated with nab-paclitaxel + carboplatin + endostatin regimen, and the control group was treated with paclitaxel + carboplatin. In this trial, the efficacy is evaluated every 8 weeks until disease progression or unacceptable toxicity,or until the investigator deemed that the patient's condition was unacceptable for further treatment. The follow-up period was 24 months after the end of treatment (follow-up patient survival information and new anti-tumor treatment). The planning enrolled sample size for nab-paclitaxel + carboplatin + endostatin group and paclitaxel-carboplatin group were 90 patients and 45 patients, respectively.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 145 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Nab-paclitaxel Plus Carboplatin Combined Endostatin Versus Solvent-based Paclitaxel Plus Carboplatin in the Treatment of Advanced Melanoma After the Failure of PD-1 Treatment #A Randomized Controlled, Open, Multicenter Trial
Actual Study Start Date : March 23, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

Arm Intervention/treatment
Experimental: nab-paclitaxel + endostatin+ carboplatin
nab-paclitaxel + endostatin+ carboplatin nab-paclitaxel 260mg/m2, d1 +Carboplatin AUC=5, d1 +endostatin 15mg, d1-14 q28d
Drug: Chemotherapeutic Combinations
nab-paclitaxel 260mg/m2 d1+Carboplatin AUC=5 d1+ endostatin 15mg d1-14,q28d

Active Comparator: paclitaxel+carboplatin
paclitaxel+carboplatin paclitaxel 175 mg/m2, d1+ Carboplatin AUC=5, d1 q21d
Drug: chemotherapy
paclitaxel 175 mg/m2 d1+Carboplatin AUC=5 d1, q21d




Primary Outcome Measures :
  1. Progression free survival (PFS) [ Time Frame: 3 years ]
    The time from treatment to tumor progression or death


Secondary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: At the end of Cycle 2 (each cycle is 28 days) ]

    response evaluation disease progression defined by Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) criteria.

    response (PR), refers to the number of cases with complete and partial response after treatment as a percentage of the total number of evaluable cases


  2. Disease Control Rate (DCR) [ Time Frame: At the end of Cycle 2 (each cycle is 28 days) ]
    The disease control rate was the proportion of patients with complete remission, partial remission and stability (SD) in all patients.

  3. overall survival (OS) [ Time Frame: 3 years ]
    OS was defined as the time from the date of the first administration of trial regimen to the date of death from any cause (event) or last follow-up (censored data).

  4. Adverse events (AE) [ Time Frame: 3 years ]
    Adverse events (AE) were monitored on an ongoing basis and classified according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. Patients were assessed for toxicities before each administration, and toxicity was graded accordingly



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years old, ≤ 70 years old, male or female;
  2. Histological or pathological diagnosis of advanced melanoma, and progressed after anti-PD-1 treatment (disease progression or unacceptable toxicity);
  3. The patient has at least one (RECIST 1.1 standard) measurable lesion, which needs to be detected by spiral CT or MRI, and the tumor lesion has at least one single diameter ≥ 1 cm;
  4. ECOG PS is 0 or 1 (see Annex 1 for standards);
  5. The estimated survival period is ≥12 weeks;
  6. no chemotherapy contraindications, including normal peripheral blood, liver and kidney function and electrocardiogram are basically normal; Peripheral blood: neutrophils ≥1.5×109/L, platelets≥90×109/ L, hemoglobin≥90 g/L; Renal function: normal serum creatinine; For patients with non-metastatic liver function impairment: alanine, aspartate aminotransferase ≤ 2.5 ULN, For patients with metastatic liver dysfunction: alanine, aspartate aminotransferase ≤ 5 ULN;
  7. Patients who have undergone topical treatment for asymptomatic brain metastases can be enrolled and have a clinical stable status of at least 4 weeks.
  8. Patients voluntarily participate in and sign an informed consent form.
  9. contraindications for the use of no carboplatin, paclitaxel, entropic and albumin paclitaxel

Exclusion Criteria:

  1. Known HIV, hepatitis B/C virus positive status or history of active tuberculosis (testing prior to randomisation is not required)
  2. Received any investigational drug within 28 days or 5 half-lives of the planned first dose of this study treatment.
  3. Active infection requiring systemic therapy.
  4. A known history of another malignancy or concurrent malignancy unless the patient is disease-free for a minimum of 1 year, is completely treated and is at low-risk of recurrence.
  5. Patients with a history or evidence of cardiovascular risk,
  6. History or evidence of interstitial lung disease or active non-infectious pneumonitis.
  7. Serious or unstable pre-existing medical conditions or other conditions that could interfere with the patient's safety, consent, or compliance.
  8. Pregnant or breastfeeding females, or expecting to conceive or father children within the projected period of study treatment (52 weeks followed by 4 months following end of study treatment).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917069


Contacts
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Contact: Lili Mao, Dr. 861013261859885 yunzhongmanbu7848@163.com
Contact: Lu Si, Dr. 861088196956

Locations
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China, Beijing
Beijing Cancer Hospital Recruiting
Beijing, Beijing, China, 100142
Contact: Lili Mao, Dr    861013261859885    yunzhongmanbu7848@163.com   
Contact: Lu Si    861088196956      
Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Principal Investigator: Jun Guo, Dr. Beijing Cancer Hospital

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Responsible Party: Jun GUO, Vice President of Beijing Cancer Hospital,Head of renal carcinoma & melanoma dept., Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03917069     History of Changes
Other Study ID Numbers: 2019NPCE
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual participant data for all primary and secondary outcome measures will be made available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available within 6 months of study completion.
Access Criteria: data access requests will be reviewed by an external Independent Review Panel.Requestors will be required to sign a Data Access Agreement.
URL: http://www.guojun.org/

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Jun GUO, Beijing Cancer Hospital:
nab-paclitaxel
carboplatin
endostatin
melanoma

Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Endostatins
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors