AMG 386 Drug-Drug Interaction Study With Paclitaxel

Amgen

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: Paclitaxel

Drug: AMG 386

Study type

Interventional

Funder types

Industry

Identifiers

NCT01992341

20101151

Details and patient eligibility

About

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

Full description

Eligible subjects enrolled in the study will begin receiving paclitaxel on a three weeks on / one week off schedule at study day 1 and weekly AMG 386 beginning at study day 8. The pharmacokinetic portion of the study occurs during the first two study cycles with intensive PK collections on study weeks 1, 6 and 8. Once the pharmacokinetic assessment period is completed, continued combination therapy with AMG 386 and paclitaxel or single-agent AMG 386 will be administered at the investigator's discretion until progression, unacceptable toxicity develops, or study withdrawal.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria

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
Concurrent or prior treatment with 2C8 and 3A4 substrates
Enrolled in or has not yet completed at least 30 days (prior to study day 1) since ending other investigational device or drug, or currently receiving other investigational treatment.
Men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 6 months after the last dose of AMG 386
Women who are lactating/breastfeeding
Women with a positive pregnancy test
Women planning to become pregnant during the duration of the study