Histologically or Cytologically Documented Solid TumorsPhase 1NCT01235416
A Phase 1b, Open-label, Dose-finding Study of AMG 706 in Combination With Gemcitabine and Erlotinib to Treat Subjects With Solid Tumors
A Phase 1 study testing AMG 706 in people with Histologically or Cytologically Documented Solid Tumors, run by Amgen.
Trial summary
This study is an open-label, dose-finding study to determine the target or maximum-tolerated dose and to characterize the safety and pharmacokinetic profile of AMG 706 administered in combination with erlotinib with or without gemcitabine in subjects with solid tumors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Histologically or Cytologically Documented Solid Tumors
- What is being tested?
- AMG 706
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Feb 2010
- 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
- histologically or cytologically documented solid tumors
- candidates for gemcitabine and erlotinib treatment (for cohorts with gemcitabine), in the opinion of the investigator
- candidates for erlotinib treatment (for cohorts without gemcitabine), in the opinion of the investigator
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2 (see Appendix E)
- systolic blood pressure ≤ 145 mm Hg and diastolic blood pressure ≤ 85 mm Hg (hypertension therapy is allowed)
- at least 18 years of age when written informed consent is obtained
- before any study-specific procedure is performed, the appropriate approved written informed consent must be obtained (Section 12.1).
Who cannot join
- nonsmall-cell lung cancer with squamous-cell histology
- large central tumor lesions (ie, ≥ 3 centimeters and located adjacent to or within the hilum or mediastinum)
- direct bowel wall invasion except for primary tumors of the bowel
- evidence of active bleeding or bleeding diathesis
- total gastrectomy
- hematologic malignancies
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- untreated or symptomatic brain metastases
- history or evidence of interstitial lung disease
- past or current history of second neoplasm, except for curatively treated non-melanoma skin cancer, carcinoma in situ of the cervix and other primary solid cancer with no known active disease present and no curative treatment administered for the last 3 years
- documented myocardial infarction within 1 year before study day 1
- arterial thrombosis or deep vein thrombosis within 1 year before study day 1
- unstable or uncontrolled disease/condition related to or impacting cardiac function (eg, unstable angina, congestive heart failure, New York Heart Association (NYHA) > class II [Appendix F])
- major surgical procedure within 30 days before study day 1
- known positive test for human immunodeficiency virus (HIV)
- absolute neutrophil count (ANC) < 1.5 x 109 /L
- platelet count < 100 x 109 /L or > 850 x 109 /L
- hemoglobin < 9 g/dL
- serum creatinine > 2.0 mg/dL or calculated clearance < 40 mL/minute
- albumin-adjusted serum calcium < 2.0 mmol/L (8.0 mg/dL)
- urine protein quantitative value of ≥ 30 mg/dL in urinalysis or ≥ 1+ on dipstick, unless 24-hour urine protein is < 500 mg
- aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN) or AST or ALT > 5.0 x ULN if the subject has documented liver metastasis or primary hepatic neoplasm
- total bilirubin > 2 x ULN (> 3 x ULN for subjects with Gilbert syndrome. Subjects with UGT1A1 promoter polymorphism, i.e. Gilbert syndrome, must be confirmed by genotyping or Invader® UGT1A1 Molecular Assay)
- prothrombin time > 2.0 international normalized ratio or partial thromboplastin time > 1.5 X ULN
- currently or previously treated with bevacizumab or small molecular inhibitors of VEGF including but not limited to SU11248 (sunitinib malate), PTK787 (vatalanib), AZD 2171, AEE-788, BAY 43- 9006 (sorafenib tosylate) and AMG 706, unless approved by Amgen
- previously treated with erlotinib
- previously treated with gemcitabine (for cohorts with gemcitabine) unless approved by Amgen
- currently treated with interferon
- systemic chemotherapy within 21 days before study day 1
- radiation therapy within 14 days before study day 1
- concurrent or prior treatment with rifampin, rifabutin, rifapentin, phenytoin, carbamazepine, or phenobarbital within 14 days before study day 1
- treatment with strong CYP 3A inhibitors or inducers (such as but not limited to ketoconazole, itraconazole, clarithromycin, erythromycin or nefazodone) or immune modulators (such as but not limited to cyclosporine and tacrolimus) 7 days before study day 1
- treatment with herbal medications containing St John's Wort within 7 days before study day 1
- treatment for systemic infection within 14 days before study day 1
- treated with > 1 mg/day of warfarin within 7 days before study day 1
- any condition which in the investigator's opinion makes the subject unsuitable for study participation
- not yet completed at least 30 days since ending other investigational device/drug trial(s), or subject is receiving other investigational treatments
- pregnant (ie, positive beta-human chorionic gonadotropin test) or is breast feeding
- not using adequate contraceptive precautions
- unable to swallow oral medications
- previously enrolled into this study
- not available for follow-up assessments
About this study
This study is an open-label, dose-finding study to determine the target or maximum-tolerated dose and to characterize the safety and pharmacokinetic profile of AMG 706 administered in combination with erlotinib with or without gemcitabine in subjects with solid tumors.
- Being tested
- AMG 706
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 706Drug
In each of these 3 planned treatment cohorts, approximately 6 evaluable subjects will be treated with gemcitabine (1000-mg/m2 intravenously over 30 minutes, once weekly starting on day 1, week 1 of cycle 1) and erlotinib (100 mg orally once daily starting on day 1, week 1 of cycle 1)
| Study group | Role | What they receive |
|---|---|---|
| AMG 706 50mg | Active comparator | 50 mg, once daily. (Cohort 1) Receives: Drug: AMG 706 |
| AMG 706 75mg | Active comparator | 75 mg, twice daily. (Cohort 2) Receives: Drug: AMG 706 |
| AMG 706 125mg | Active comparator | 125 mg, once daily. (Cohort 3) Receives: Drug: AMG 706 |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of dose-limiting toxicities
Measured: Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706
Secondary outcomes (2)
Incidence of adverse events (including serious and treatment-related) and significant laboratory values other than those defined as dose-limiting toxicities
Measured: Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706
pharmacokinetic profiles of erlotinib and AMG 706
Measured: Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2010 (estimated)
- Study startSep 2005
- Primary completionApr 2008
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Histologically or Cytologically Documented 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01235416
- Sponsor's protocol ID
- 20050107
- Status last verified
- Jan 2011
- First submitted
- 29 Oct 2010
- Last updated
- 21 Jan 2011
- Results posted
- No
Publications
Kotasek D, Tebbutt N, Desai J, Welch S, Siu LL, McCoy S, Sun YN, Johnson J, Adewoye AH, Price T. Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study. BMC Cancer. 2011 Jul 26;11:313. doi: 10.1186/1471-2407-11-313.
PubMed 21791058
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Open-label, Dose-finding Study of AMG 706 in Combination With Gemcitabine and Erlotinib to Treat Subjects With Solid Tumors
- ClinicalTrials.gov ID
- NCT01235416
- Acronym / sponsor ID
- 20050107
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Apr 2008 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 5 Nov 2010 (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.
This study is an open-label, dose-finding study to determine the target or maximum-tolerated dose and to characterize the safety and pharmacokinetic profile of AMG 706 administered in combination with erlotinib with or without gemcitabine in subjects with solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMG 706 50mg | Active comparator | Drug: AMG 70650 mg, once daily. (Cohort 1) |
| AMG 706 75mg | Active comparator | Drug: AMG 70675 mg, twice daily. (Cohort 2) |
| AMG 706 125mg | Active comparator | Drug: AMG 706125 mg, once daily. (Cohort 3) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- histologically or cytologically documented solid tumors
- candidates for gemcitabine and erlotinib treatment (for cohorts with gemcitabine), in the opinion of the investigator
- candidates for erlotinib treatment (for cohorts without gemcitabine), in the opinion of the investigator
- Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 2 (see Appendix E)
- systolic blood pressure ≤ 145 mm Hg and diastolic blood pressure ≤ 85 mm Hg (hypertension therapy is allowed)
Key exclusion criteria (41 listed)
- nonsmall-cell lung cancer with squamous-cell histology
- large central tumor lesions (ie, ≥ 3 centimeters and located adjacent to or within the hilum or mediastinum)
- direct bowel wall invasion except for primary tumors of the bowel
- evidence of active bleeding or bleeding diathesis
- total gastrectomy
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 706In each of these 3 planned treatment cohorts, approximately 6 evaluable subjects will be treated with gemcitabine (1000-mg/m2 intravenously over 30 minutes, once weekly starting on day 1, week 1 of cycle 1) and erlotinib (100 mg orally once daily starting on day 1, week 1 of cycle 1) | Drug | AMG 706 125mg, AMG 706 50mg, AMG 706 75mg |
Primary outcome
incidence of dose-limiting toxicities
Time frame: Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706
2 secondary outcomes
Incidence of adverse events (including serious and treatment-related) and significant laboratory values other than those defined as dose-limiting toxicities
Time frame: Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706
pharmacokinetic profiles of erlotinib and AMG 706
Time frame: Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706
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 21 Jan 2011.
- Derived from this study: PubMed 21791058Kotasek D, Tebbutt N, Desai J, Welch S, Siu LL, McCoy S, Sun YN, Johnson J, Adewoye AH, Price T. Safety and pharmacokinetics of motesanib in combination with gemcitabine and erlotinib for the treatment of solid tumors: a phase 1b study. BMC Cancer. 2011 Jul 26;11:313. doi: 10.1186/1471-2407-11-313.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 706 in people with Histologically or Cytologically Documented Solid Tumors, run by Amgen.
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 7 inclusion and 41 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 21 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
incidence of dose-limiting toxicities (time frame: Subjects will be in this study for up to 54 weeks (ie, 2 weeks screening, 48 weeks treatment and 4 weeks follow-up) or longer if subjects are deemed to have continuous clinical benefit from the combination chemotherapy and AMG 706). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01235416, which also lists 1 linked publication.
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 21 Jan 2011.