UMIN-CTR Clinical Trial

Public title

Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. (KTOSG1301)

Acronym

Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. (KTOSG1301)

Scientific Title

Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. (KTOSG1301)

Scientific Title:Acronym

Phase II study of weekly nanoparticle albumin-bound paclitaxel for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy. (KTOSG1301)

Region

Japan

Condition

Non-small cell lung cancer

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To explore efficacy and safety of weekly nab-paclitaxel therapy for patients with advanced non-small cell lung cancer previously treated with platinum-based chemotherapy.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Phase II

Primary outcomes

Objective response rate

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Nab-paclitaxel 100mg/m2 on day 1,8,15
Cycles are repeated every three weeks.

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Histologically or cytologically confirmed diagnosis of NSCLC.
2) Non-small cell lung cancer with stage IIIB,stageIV
3) Age of 20 years or older
4) Performance Status (ECOG) 0-2
5) Tumor has the evaluable lesion.
6) Patient previously treated with platinum-based chemotherapy .and who including EGFR-TKI, ALK inhibitor or maintenance chemotherapy but excluding switch maintenance.
*Recurrence within a year or less from the day adjuvant chemotherapy finished is considered a previous treatment.
7) Have adequate organ function within two week before study entry
a.Granulocyte count 1,500/mm3 or over
b.Platelet count 100,000/mm3 or over
c.Hb 9.0 g/dl or over
d.AST (GOT) 2.5 x the Upper Limits of Normal (ULN) or under
e.ALT (GPT) 2.5 x the Upper Limits of Normal (ULN) or under
f.Total bilirubin 1.5 mg/dL or under
g.Serum creatinine 1.5 mg/dl or under
h.PaO2 60torr or over or SpO2 90% or over
8) Written informed consent to participate.

Key exclusion criteria

1) Anamnesis of hypersensitivity to paclitaxel or albumin
2) Treatment history of taxanes (recurrence after more than one year from adjuvant chemotherapy including taxanes is permitted.)
3) Patient received chemotherapy within 4 weeks or EGFR-TKI within 2 weeks.
4) Patient received curative radiotherapy within 6 weeks or regional palliative radiotherapy within 2weeks.
5) Patient received operation within 4 weeks or surgical open within 2 weeks.
6) Symptomatic brain metastasis
7) Pleural effusion, cardiac effusion, or cardiac effusion necessitating treatment.
8) Active infectious disease in need of systemic administration of anti-bacterial drugs
9) Severe complication (ileus , interstitial pneumonia , interstitial pneumonia , pulmonary fibrosis, uncontrolled diabetes , heart failure , renal failure, hepatic failure, and so on)
10) Patient needed to be administered with immunosuppressive drugs such as azathioprine , cyclophosphamide , methotrexate , or steroid
11) Active double cancer within 5 years of disease free interval (but, registerable for cured cutaneous basal cell carcinomas and cervical cancer, cured gastric cancer, esophageal cancer and pm-colorectal cancer ,by endoscopic mucosal resection , curative cutaneous cancer except for malignant melanoma )
12) Peripheral neuropathy Grade2 or over
13) Pregnancy or lactating patients , or no intention to practice birth control.
14) Uncontrolled psychiatric disease
15) Physician judged improper to entry this trial

Target sample size

41

Name of lead principal investigator

1st name
Middle name
Last name	Sho Saeki

Organization

Kumamoto University School
of Medicine

Division name

Department of Respiratory Medicine

Zip code

Address

1-1-1 Honjo,chuo-ku ,Kumamoto

TEL

096-373-5012

Email

saeshow@wg7.so-net.ne.jp

Name of contact person

1st name
Middle name
Last name	Shinya Sakata

Organization

Kumamoto University School

Division name

Department of Respiratory Medicine

Zip code

Address

1-1-1 Honjo, chuo-ku ,Kumamoto

TEL

096-373-5012

Homepage URL

Email

sakata-1027@hotmail.co.jp

Institute

Department of Respiratory Medicine , Kumamoto University School
of Medicine

Institute

Department

Personal name

Organization

no

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2013

Year

05

Month

01

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://www.lungcancerjournal.info/

Number of participants that the trial has enrolled

Results

Lung Cancer 2016, in press
Results: Forty-one patients were enrolled between September 2013 and April 2015. The ORR was 31.7 % (90% confidence interval, 19.3% to 44.1%), which met the primary objective of the study. Median progression-free survival was 4.9 months (95% confidence interval, 2.4 to 7.4 months) and median overall survival was 13.0 (95% confidence interval, 8.0 to 18.0 months) months. The median number of treatment cycles was four (range, 1 to 17) over the entire study period, and the median dose intensity was 89.1 mg/m2 per week. Hematologic toxicities of grade 3 or 4 included neutropenia (19.5%) and leukopenia (17.1%), with no cases of febrile neutropenia being observed. Individual nonhematologic toxicities of grade 3 or higher occurred with a frequency of <5%.
Conclusion: Weekly nab-paclitaxel was associated with acceptable toxicity and a favorable ORR in previously treated patients with advanced NSCLC. Our results justify the undertaking of a phase III trial comparing nab-paclitaxel with docetaxel in this patient population.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2013

Year

04

Month

03

Day

Date of IRB

Anticipated trial start date

2013

Year

05

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

04

Month

18

Day

Last modified on

2016

Year

06

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012315