Advanced Solid TumorsPhase 1NCT01992341
AMG 386 Drug-Drug Interaction Study With Paclitaxel
A Phase 1 study testing AMG 386 and Paclitaxel in people with Advanced Solid Tumors, run by Amgen at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- AMG 386 and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2012to Sep 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Cancer Center
Aurora, Colorado, 80045
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: An Open-Label, Pharmacokinetic Drug-Drug Interaction (DDI) Study of AMG 386 in Combination With Paclitaxel in Adult Subjects With Advanced Solid Tumors
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
Read the detailed 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- AMG 386, Paclitaxel
- Keywords
- sarcomas, carcinomas
- Medical subject headings
- Sarcoma, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 386Drug
Also called Taxol
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| AMG 386 15mg/kg and paclitaxel 80mg/m2 | Experimental | Not described Receives: Drug: AMG 386; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Paclitaxel PK parameters
Paclitaxel PK parameters with and without the co-administration of AMG 386.
Measured: 9 weeks
Secondary outcomes (3)
AMG 386 PK parameters
AMG 386 PK steady state PK parameters with and without paclitaxel co-administration
Measured: 9 weeks
Safety
Subject incidence of treatment-emergent adverse events: Assessments include physical examinations, vitals, clinical laboratories, and electrocardiograms (ECG) • Results of safety laboratory tests, vital sign measurements, and ECG measurments
Measured: Average of 6 months
Safety
Incidence of anti-AMG 386 antibody formation
Measured: Average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992341
- Sponsor's protocol ID
- 20101151
- Status last verified
- Sep 2014
- First submitted
- 14 Jun 2012
- Last updated
- 23 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Pharmacokinetic Drug-Drug Interaction (DDI) Study of AMG 386 in Combination With Paclitaxel in Adult Subjects With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT01992341
- Acronym / sponsor ID
- 20101151
- Conditions
- Advanced Solid Tumors
- Keywords
- sarcomas, carcinomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMG 386 15mg/kg and paclitaxel 80mg/m2 | Experimental | Drug: AMG 386, Drug: Paclitaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 386Also: TaxolWeekly 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. | Drug | AMG 386 15mg/kg and paclitaxel 80mg/m2 |
| PaclitaxelThree 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. | Drug | AMG 386 15mg/kg and paclitaxel 80mg/m2 |
Primary outcome
Paclitaxel PK parameters
Time frame: 9 weeks
Paclitaxel PK parameters with and without the co-administration of AMG 386.
3 secondary outcomes
AMG 386 PK parameters
Time frame: 9 weeks
Safety
Time frame: Average of 6 months
Safety
Time frame: Average of 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2014.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 386 and Paclitaxel in people with Advanced Solid Tumors, run by Amgen at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Paclitaxel PK parameters (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2014.