UMIN-CTR Clinical Trial

Public title

Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer

Acronym

Phase I study of amrubicin and paclitaxel

Scientific Title

Phase I dose escalation study of amrubicin plus paclitaxel in previously treated advanced non-small cell lung cancer

Scientific Title:Acronym

Phase I study of amrubicin and paclitaxel

Region

Japan

Condition

NSCLC

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

We conducted a phase I dose escalation study to determine the maximum dose (MTD), the recommended dose (RD) and the safety profile of amrubicin (AMR) plus paclitaxel (PTX) combination regimen for patients with previously treated non-small-cell lung cancer (NSCLC).

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase I

Primary outcomes

Doses were escalated according to the frequency of dose limiting toxicity (DLT) evaluated the first cycle of chemotherapy. At least three patients were enrolled at each dose level. Initially, 3 patients were treated at dose level 1, and no intra-patient dose escalation was allowed. If one DLT was observed in the first three patients, 3 more patients were entered at this dose level and dose escalation continued to the next level if fewer than 3 of 6 patients experienced DLT. The MTD was defined as the previous level from the level at which DLT was observed in 2 out of 3 or in 3 out of 6 patients. If 2 out of 3 or 3 out of 6 patients experienced a DLT at level 1, a dose reduction to level 0 was planned. DLT was defined as: (1) grade 4 neutropenia lasting longer than 4 days; (2) grade 4 thrombocytopenia; (3) grade 3 febrile neutropenia; (5) grade 3 or worse nonhematologic toxicities except nausea/vomiting; (6) any unresolved toxicity requiring a delay in the administration of a subsequent cycle exceeding 14 days; and (7) any grade 2 toxicity which, in the judgement of the investigator, required dose reduction or discontinuation of therapy.

Key secondary outcomes

Response, biomarker

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

All patients were treated with AMR and PTX every 4 weeks. PTX was administered at a fixed dose of 150 mg/m2/day on day 1, and AMR was intravenously administered at a starting dose of 25 mg/m2/day on days 1 to 3. Subsequent dose levels were 25 mg/m2 (level 1) and 30 mg/m2 (level 2 and 3)

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

Eligible patients were required to have: histologically and/or cytologically proven NSCLC; recurrent or refractory disease after one or two previous chemotherapy regimens; a performance status (PS) of 0-2 on the Eastern Cooperative Oncology Group; an age with ;20 years; a life expectancy of 8 weeks or more; adequate bone marrow reserve (leukocyte count , absolute neutrophil count ;1500 mm-3, platelet count ;100000 mm-3, and hemoglobin 9 g dL-1); adequate function (total serum bilirubin ;1.5 mg dL-1, aspartate transaminase (AST), alanine transaminase (ALT) less than twice the upper limit of the normal range and serum creatinine ;1.5 mg dL-1); ECG findings within the normal range, and a left ventricular ejection fraction ;50%; arterial oxygen partial pressure ;60 torr.

Key exclusion criteria

Patients with concomitant malignancy, central nervous system metastases, active infectious diseases or other serious medical problems were ineligible.

Target sample size

12

Name of lead principal investigator

1st name
Middle name
Last name	Kyoichi Kaira

Organization

Gunma University Hospital

Division name

respiratory medicine

Zip code

Address

Maebashi, Gunma , Japan

TEL

027-220-8136

Email

kkaira1970@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Kyoichi Kaira

Organization

Gunma University Hospital

Division name

respiratory medicine

Zip code

Address

Maebashi, Gunma , Japan

TEL

027-220-8136

Homepage URL

Email

kkaira1970@yahoo.co.jp

Institute

Gunma University

Institute

Department

Personal name

Organization

Gunma University

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

2015

Year

08

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

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

02

Month

05

Day

Date of IRB

Anticipated trial start date

2013

Year

04

Month

03

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2015

Year

08

Month

14

Day

Last modified on

2015

Year

08

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021622