A Trial to Determine the Maximum Tolerated Dose and Evaluate the Safety and Pharmacokinetics of Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel, in Subjects With Advanced Solid Malignancies

NCT01103791 | Completed Phase 1 DMC

• 1 other identifier: DOPNP101
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I trial to determine the maximum tolerated dose and recommended phase II dose of docetaxel-PNP (polymeric nanoparticle formulation of docetaxel) and to evaluate the safety and pharmacokinetics of docetaxel-PNP in subjects with advanced solid malignancies.

Conditions

Advanced Solid Malignancies

Outcome Measures

Primary Outcomes (2)

• The maximum tolerated dose (MTD) of Docetaxel-PNP

  Administration of docetaxel-PNP was well tolerated up 6mg/m² every 3weeks by heavily pretreated patients.

  up to 6 cycle

• The recommended phase II dose of Docetaxel-PNP

  Futher phase Ⅱ Trials are recommended at this dose level

  up to 6 cycle

Secondary Outcomes (3)

• The Dose Limiting Toxicity (DLT)

  up to 6 cycle

• The pharmacokinetics of Docetaxel-PNP on Day 1 of 1st cycle (AUC, CL, T1/2, Tmax, Cmax, Vdss)

  up to 6 cycle

• Objective response rate

  up to 6 cycle

Study Arms (6)

Cohort 1

EXPERIMENTAL

Docetaxel-PNP 20mg/m2

Drug: Docetaxel-PNP

Cohort 2

EXPERIMENTAL

Docetaxel-PNP 35mg/m2

Drug: Docetaxel-PNP

Cohort 3

EXPERIMENTAL

Docetaxel-PNP 45mg/m2

Drug: Docetaxel-PNP

Cohort 4

EXPERIMENTAL

Docetaxel-PNP 60mg/m2

Drug: Docetaxel-PNP

Cohort 5

EXPERIMENTAL

Docetaxel-PNP 75mg/m2

Drug: Docetaxel-PNP

Cohort 6

EXPERIMENTAL

Docetaxel-PNP 90mg/m2

Drug: Docetaxel-PNP

Interventions

Docetaxel-PNP DRUG

Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6

Eligibility Criteria

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

You may qualify if:

• Patient ages more than 18 years old
• Patient should voluntarily sign a written informed consent before study entry
• Patient historically or cytologically confirmed diagnosis of advanced solid tumor and patient with measurable disease or evaluable disease by RECIST criteria
• Progressive disease with development of new lesions or an increase in preexisting lesions or standard therapy in order to provide clinical benefit does not exist or is no longer effective
• Previous anti-cancer therapies must be completed before 21days of first study dose and Patient must have recovered from any previous therapy
• Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
• Patient has a life expectancy of at least 3 months
• Baseline studies for determining eligibility must be completed within 14 days of first study dose and patient has a adequate organ function including the following:
• Hb ≥ 10g/dl
• ANC ≥ 1.5 X 109/L
• Platelet count ≥ 100 X 109/L
• Serum total bilirubin ≤ 1.5 mg/dL
• Serum AST and ALT ≤ 2.5 X UNL
• Serum ALP ≤ 2.5ⅹUNL
• Serum creatinine ≤ 1.5 X UNL

You may not qualify if:

• Patient has had a major surgery except tumor ablation within 2 weeks before screening visit
• Patient has a brain metastasis with neurologic symptom
• Patient has a sensory neuropathy or motor neuropathy ≥ grade 2 by NCI-CTCAE
• Patient has any serious concurrent disease such as:
• Any medical or psychiatric condition that, in the opinion of the investigator, would prohibit the understanding and giving of informed consent Severe cardiovascular disease (e.g. ischemic heart disease requiring medication or myocardial infraction within the past six months, grade 3-4 congestive heart failure defined by the New York Heart Association criteria) Active un controlled infection.
• Patient has hypersensitivity to the Investigational product or their excipients
• Patient has participated in any other clinical trial within 4 weeks before screening visit
• Woman is pregnant or breast feeding
• Subjects who are of childbearing potential who do not use a medically acceptable method of birth control or do not agree to continue use of this method throughout the trial (screening, treatment period, and 3 weeks from the last done). A negative pregnancy test (urine or serum) should be documented within 14 days prior to initiation of trial medication for women of childbearing potential who have not been amenorrheic for at least 12 months prior to registration into the trial or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy). Medically acceptable methods include:
• Barrier method with spermicide
• Intrauterine device
• Complete abstinence, etc.
• Patient who has a history of resistance, intolerance, or no response to Docetaxel therapy

Sponsors & Collaborators

• Samyang Biopharmaceuticals Corporation: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

Location

Study Officials

• Kyung Hae Jung, Ph. D.

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2010
• First Posted: April 15, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: April 1, 2012
• Last Updated: May 5, 2017

Record last verified: 2017-05

Locations

KR (1)