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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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8 October 2021 |
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Main ID: |
EUCTR2007-004722-25-FR |
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Date of registration:
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25/03/2008 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Phase 1b/2 Trial of AMG 655 in Combination with Panitumumab in Subjects with Metastatic Colorectal Cancer
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Scientific title:
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A Phase 1b/2 Trial of AMG 655 in Combination with Panitumumab in Subjects with Metastatic Colorectal Cancer |
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Date of first enrolment:
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17/04/2008 |
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Target sample size:
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65 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-004722-25 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
Inclusion Criteria
Disease Related
- Histologically or cytologically confirmed metastatic adenocarcinoma of the
colon or rectum
- Radiographically documented disease progression per modified RECIST
during or following treatment with fluoropyrimidine, irinotecan, and/or
oxaliplatin chemotherapy for mCRC. Progressive disease must be
documented during or = 6 months after the last dose of the most recent
chemotherapy regimen prior to enrollment
- At least 1 uni-dimensionally measurable lesion measuring = 20 mm in one
dimension per modified RECIST (Appendix D). Lesion must not be chosen
from a previously irradiated field, unless there has been documented disease
progression in that field after irradiation and prior to enrollment. All sites of
disease must be evaluated.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Available archived paraffin-embedded tumor tissue from the primary tumor or
metastasis for submission to the central laboratory (see Section 7.7)
Demographic
- Man or woman = 18 years of age at the time of enrollment
Laboratory (performed = 7 days before enrollment)
- Hematologic function within the following limits:
- Absolute neutrophil count (ANC) > 1.0 x 109 cells/L
- Platelets = 100 x 109/L
- Renal function within the following limits:
- Creatinine < 2.0 mg/dL
- Hepatic function within the following limits:
- Aspartate aminotransferase (AST) = 2.5 x ULN (= 5 x ULN if liver
metastases)
- Alanine aminotransferase (ALT) = 2.5 x ULN (= 5 x ULN if liver
metastases)
- Bilirubin = 2 x ULN
- Metabolic function within the following limits:
- Amylase = 2 x ULN
- Lipase = 2 x ULN
- Magnesium = lower limit of normal
- Negative pregnancy test = 72 hours before enrollment (for woman of
childbearing potential only)
Medications
- Subject must have received 1, 2, or 3 prior chemotherapy regimens for
mCRC
Ethical
- Competent to comprehend, sign, and date the IEC/IRB approved written
informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Disease Related
- History of other primary cancer, unless:
- Curatively resected non-melanomatous skin cancer
- Curatively treated cervical carcinoma in situ
- Other primary solid tumor curatively treated with no known active disease
present and no treatment administered for = 5 years before enrollment
Medications
- Prior treatment with anti-EGFr inhibitors (eg, cetuximab, erlotinib, gefitinib),
unless treatment was received in the adjuvant setting = 6 months before
enrollment
- Use of systemic chemotherapy and radiotherapy = 30 days before enrollment
- Use of prior anti-tumor therapies with a short serum half-life (less than
1 week) including prior experimental agents or approved anti-tumor small
molecules = 30 days before enrollment
- Use of anti-tumor therapies with a longer serum half-life (eg, bevacizumab)
including prior experimental or approved protein/antibodies = 42 days before
enrollment
- Any investigational agent or therapy = 30 days before enrollment
- Known allergy or hypersensitivity to any component of panitumumab and/or
AMG 655
General
- History of or known presence of central nervous system (CNS) metastases
- History of interstitial lung disease (eg, pneumonitis, pulmonary fibrosis) or
evidence of interstitial lung disease on baseline chest computerized
tomography (CT) scan
- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled
cardiac arrhythmia) = 1 year before enrollment
- Active inflammatory bowel disease or other active bowel disease causing
chronic diarrhea (defined as = CTC grade 2 [CTCAE version 3.0])
- Known positive test for human immunodeficiency virus (HIV) infection,
hepatitis C virus, acute or chronic hepatitis B infection
- Any co-morbid disease or condition that could increase the risk of toxicity
(eg, significant ascites, significant pleural effusion)
- Any uncontrolled concurrent illness (eg, infection, bleeding) or history of any
medical condition that may interfere with the interpretation of the study results
- Major surgical procedure (requiring general anesthesia) = 28 days or minor
surgical procedure (excluding central venous catheter placement) = 14 days
before enrollment. Subjects must have recovered from surgery related toxicities.
- Other investigational procedures are excluded
- Subject is currently pregnant or breast feeding
- Man or woman of childbearing potential who is not willing to use adequate
contraceptive precautions during treatment and for 6 months (for women) or
1 month (for men) after the last investigational product administration.
Adequate contraceptive precautions includes double barrier contraceptive
methods (eg, diaphragm and condom) or abstinence.
- Previously enrolled into this study
- Subject unwilling or unable to comply with study requirements
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Colorectal cancer (CRC)
MedDRA version: 9.1
Level: LLT
Classification code 10052358
Term: Colorectal cancer metastatic
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Intervention(s)
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Product Name: AMG 655
Product Code: AMG 655
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: AMG 655
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 30-
Product Name: Panitumumab
Pharmaceutical Form: Intravenous infusion
INN or Proposed INN: Panitumumab
Current Sponsor code: AMG 655
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 20-
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Primary Outcome(s)
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Primary end point(s): Part 1 - Dose-limiting Toxicity (DLT): Incidence of selected adverse events and
laboratory abnormalities as defined in Section 6.6 of the Protocol.
Part 2 - Overall Objective Response (OR): The incidence during the treatment phase of either a confirmed CR or PR per modified RECIST criteria (responder). A confirmed CR requires 2 assessments of CR at least 28 days apart. A confirmed PR requires
2 assessments at least 28 days apart of PR or CR. All subjects that do not meet the
criteria for an objective response by the analysis cutoff date will be considered nonresponders.
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Main Objective: This study is divided into 2 parts: a phase 1b portion (part 1) and a phase 2 portion
(part 2).
Part 1: The primary objective of part 1 is to identify a tolerable dose of AMG 655 in
combination with panitumumab based on the incidence of dose-limiting toxicities (DLTs)
in subjects with metastatic colorectal cancer (mCRC).
Part 2: The primary objective of part 2 is to evaluate stratified by KRAS status (wild-type versus mutant) the objective response rate (ORR) in subjects with mCRC treated with the combination of panitumumab and AMG 655 (tolerable dose identified in part 1).
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Secondary Objective: Secondary
Part 1 and 2: To evaluate the effect of the combination of panitumumab and AMG 655
overall and stratified by KRAS status (wild-type versus mutant) on the following
secondary endpoints in subjects with mCRC:
• Incidence of all adverse events (AEs) and clinical laboratory abnormalities
• Incidence of human anti-panitumumab antibodies (HAPA) and human
anti-AMG 655 antibodies
• Objective response (OR)
• Duration of response
• Time to response
• Disease control rate (includes complete response [CR] and partial response
[PR], or stable disease [SD])
• Progression-free survival (PFS)
• Overall survival (OS)
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Secondary ID(s)
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2007-004722-25-BE
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20060332
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 03/04/2008
Contact:
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