NCT03095079

Brief Summary

The incidence of Melanoma is rapidly growthing,and in China,dacarbazine combined with cisplatin is conmendly used as the first-line chemotherapy of metastatic melanoma. But the response rate and survival results are very limited.This trial aim to add a safe and effective anti-angiogenesis drug,Human-recombinant endostatin,to find out a new strategy which may further extend the PFS and OS with a tolerated toxicity.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

March 29, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

March 20, 2017

Last Update Submit

March 23, 2017

Conditions

Melanoma

Keywords

endostardacarbazinecisplatin

Outcome Measures

Primary Outcomes (1)

  • progress-free survival(PFS)

    Progression Free Survival is defined as the time from enrollment to the date of first documented disease progression or death from any cause

    From randomization up to 144 weeks

Secondary Outcomes (2)

  • Disease control rate(DCR)

    From randomization up to 144 weeks

  • adverse events

    From randomization up to 144 weeks

Study Arms (1)

EDP

EXPERIMENTAL

Dacarbazine,DTIC： 250 mg/m2/d，IV, d1-5 Cisplatin PDD：75 mg/m2，IV Endostar ENDO：15 mg/m2/d，CIV,d1\~14

Drug: recombinant human endostatin

Interventions

recombinant human endostatinDRUG

Cisplatin:dose was based on patient's weight and could be adjusted for weight change,75 mg/m\^2 by IV infusion separated in 3 different days Dacarbazine:250mg/m2,administered by intravenous (IV) infusion on the 1 to 5 day of each cycle Hr-endostatin:dose based on body surface area as 15mg/m2,continuous intravenous infusion from day 1 to day 14

Also known as: endostar
EDP

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. Histologically confirmed melanoma with metastases and has no received any systemic treatment.
  • At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
  • Estimated life expectancy of 12 weeks or greater
  • \. ECOG performance status 0, 1
  • Adequate organ function
  • Without symptoms of brain metastases and stable in neuro-functions

You may not qualify if:

  • \. Pregnant or lactation women
  • \. Acute infections without control.
  • \. Heart disease history, cardiac function class≥NYHA II.
  • \. HIV positive or chronic HBV/HCV in active stage.
  • \. Brain metastases or primary tumor with positive symptoms
  • \. Need anti-epileptic treatments
  • \. Organ transplantation history
  • \. Hemorrhagic tendency or related history
  • \. Renal dialysis patients
  • \. Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
  • \. Current treatment on another clinical trial
  • \. The other improper situations which investigator judged.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Related Publications (1)

  • Cui C, Mao L, Chi Z, Si L, Sheng X, Kong Y, Li S, Lian B, Gu K, Tao M, Song X, Lin T, Ren X, Qin S, Guo J. A phase II, randomized, double-blind, placebo-controlled multicenter trial of Endostar in patients with metastatic melanoma. Mol Ther. 2013 Jul;21(7):1456-63. doi: 10.1038/mt.2013.79. Epub 2013 May 14.

    PMID: 23670576RESULT

MeSH Terms

Conditions

Melanoma

Interventions

Endostatinsendostar protein

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Angiostatic ProteinsAngiogenic ProteinsIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsCollagen Type XVIIINon-Fibrillar CollagensCollagenExtracellular Matrix ProteinsScleroproteinsBiological Factors

Central Study Contacts

Chuanliang Cui, MD

CONTACT

0086-10-881969511008ccl@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of department of renal cancer and melanoma Affiliation: Beijing Cancer Hospital

Study Record Dates

First Submitted

March 20, 2017

First Posted

March 29, 2017

Study Start

October 1, 2016

Primary Completion

December 1, 2017

Study Completion

October 1, 2018

Last Updated

March 29, 2017

Record last verified: 2017-03

Locations

CN(1)