NCT01992341

Brief Summary

The purpose of this study is to evaluate the pharmacokinetics of paclitaxel when given alone and in combination with AMG 386 to determine whether AMG 386 alters the pharmacokinetics of paclitaxel

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2012

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

June 14, 2012

Completed
17 days until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

September 23, 2014

Status Verified

September 1, 2014

Enrollment Period

1.1 years

First QC Date

June 14, 2012

Last Update Submit

September 19, 2014

Conditions

Advanced Solid Tumors

Keywords

sarcomascarcinomas

Outcome Measures

Primary Outcomes (1)

  • Paclitaxel PK parameters

    Paclitaxel PK parameters with and without the co-administration of AMG 386.

    9 weeks

Secondary Outcomes (3)

  • AMG 386 PK parameters

    9 weeks

  • Safety

    Average of 6 months

  • Safety

    Average of 6 months

Study Arms (1)

AMG 386 15mg/kg and paclitaxel 80mg/m2

EXPERIMENTAL
Drug: AMG 386Drug: Paclitaxel

Interventions

AMG 386DRUG

Weekly 15 mg/kg of AMG 386 in combination with three weeks on/ one week off 80mg/m2 of paclitaxel. Continued therapy with AMG 386 with or without paclitaxel until progression, unacceptable toxicity develops, or study withdrawal.

Also known as: Taxol
AMG 386 15mg/kg and paclitaxel 80mg/m2
PaclitaxelDRUG

Three weeks on/ one week off 80mg/m2 of paclitaxel in combination with weekly 15 mg/kg of AMG 386 . Continued therapy with AMG 386 until progression, unacceptable toxicity develops, or study withdrawal. A cycle consists of 3 weeks on / 1 week off of paclitaxel.

AMG 386 15mg/kg and paclitaxel 80mg/m2

Eligibility Criteria

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

You may qualify if:

  • Men or women ≥ 18 years of age
  • Have a pathologically documented, and definitely diagnosed, advanced solid tumor that is refractory to standard treatment, or for which no curative therapy is available
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Normal or clinically acceptable ECG (12 lead reporting PR, QRS, QTc)

You may not qualify if:

  • Subjects with gastric cancer or any malignancy with purely squamous cell histology
  • Known history of primary central nervous system (CNS) tumors or CNS metastases
  • Myocardial infarction within 1 year before study day 1, unstable or uncontrolled disease/condition related to or affecting cardiac function
  • History of stroke, arterial or venous thrombosis, or pulmonary embolism within 1 year before study day 1
  • A baseline ECG QTc interval \> 450 msec
  • Active grade 2 or greater peripheral vascular disease
  • History of pulmonary hemorrhage or gross hemoptysis within 6 months before study day 1
  • Non-healing wound, ulcer (including gastrointestinal) or fracture
  • Known positive test for human immunodeficiency virus infection, or active hepatitis B or hepatitis C infection
  • Major surgery within 1 month before study day 1
  • Concurrent antitumor treatment within 4 weeks (6 weeks for nitrosoureas or mitomycin) before study day 1
  • Unable to tolerate IV administration or repeated blood withdrawal
  • Hypersensitivity to paclitaxel or drugs using the vehicle cremophor
  • Known sensitivity to mammalian-derived products, bacterially-produced proteins, or any of the products to be administered during dosing
  • Chronic neuropathy grade ≥ 1
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

University of Utah Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States

Location

Related Links

MeSH Terms

Conditions

SarcomaCarcinoma

Interventions

trebananibPaclitaxel

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and Epithelial

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2012

First Posted

November 25, 2013

Study Start

July 1, 2012

Primary Completion

August 1, 2013

Study Completion

September 1, 2014

Last Updated

September 23, 2014

Record last verified: 2014-09

Locations

US(2)