- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01483638
Axitinib as Maintenance Treatment in Patients With Metastatic CRC (TTD-11-01)
May 11, 2016 updated by: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
A Phase II Study of Axitinib as Maintenance Treatment for Patients With Metastatic Colorectal Carcinoma
The purpose of this study is to evaluate the maintenance therapy with axitinib in patients with metastatic colorectal carcinoma
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
84
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Madrid, Spain, 28046
- Spanish Cooperative Group for Digestive Tumour Therapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patient must have histological or cytological confirmed colorectal adenocarcinoma with metastatic disease documented on diagnostic imaging studies, not susceptible of radical surgery of metastases, and a low burden of disease.
- Patients without progressive disease after six months of the standard first line chemotherapy regimen for CRC (5FU or capecitabine ± oxaliplatin or irinotecan ± bevacizumab or cetuximab).
- Patient must have at least one measurable lesion as defined by modified RECIST criteria.
- Male or female, age ≥18 years.
- ECOG performance status of 0 or 1 and life expectancy of ≥12 weeks.
Adequate organ function as defined by the following criteria:
- absolute neutrophil count (ANC) ≥1500 cells/mm3;
- platelets ≥100,000 cells/mm3.
- Hemoglobin ≥9.0 g/dL.
- AST and ALT ≤2.5 x upper limit of normal (ULN), unless there are liver metastases in which case AST and ALT ≤5.0 x ULN;
- Total bilirubin ≤1.5 x ULN;
- Alkaline phosphatase <300U/l
- Serum creatinine ≤1.5 x ULN or calculated creatinine clearance ≥50 mL/min;
- Urinary protein <2+ by urine dipstick. If dipstick is ≥2+ then a 24-hour urine collection can be done and the patient may enter only if urinary protein is <2 g per 24 hours.
- At least 4 weeks since the end of prior systemic treatment, radiotherapy, or surgical procedure with resolution of all treatment-related toxicity to NCI CTCAE Version 4.0 grade ≤1 or back to baseline except for alopecia or neurotoxicity
- No evidence of pre existing uncontrolled hypertension as documented by 2 baseline blood pressure readings taken at least 1 hour apart. The baseline systolic blood pressure readings must be ≤140 mm Hg, and the baseline diastolic blood pressure readings must be ≤90 mm Hg. Patients whose hypertension is controlled by antihypertensive therapies are eligible.
- Women of childbearing potential must have a negative serum or urine pregnancy test within 3 days prior to treatment.
- Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment.
- Willingness and ability to comply with scheduled visits, treatment plans (including willingness to take either AG-013736 or placebo according to randomization), laboratory tests, and other study procedures.
Exclusion Criteria:
Gastrointestinal abnormalities including:
- inability to take oral medication;
- requirement for intravenous alimentation;
- prior surgical procedures affecting absorption including total gastric resection;
- treatment for active peptic ulcer disease in the past 6 months;
- active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past 3 months without evidence of resolution documented by endoscopy or colonoscopy;
- malabsorption syndromes.
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to start, unless affected area has been removed surgically
- Current use or anticipated need for treatment with drugs that are known potent CYP3A4 inhibitors (ie, grapefruit juice, verapamil, ketoconazole, miconazole, itraconazole, erythromycin, telithromycin, clarithromycin, indinavir, saquinavir, ritonavir, nelfinavir, lopinavir, atazanavir, amprenavir, fosamprenavir and delavirdine).
- Current use or anticipated need for treatment with drugs that are known CYP3A4 or CYP1A2 inducers (ie, carbamazepine, dexamethasone, felbamate, omeprazole, phenobarbital, phenytoin, amobarbital, nevirapine, primidone, rifabutin, rifampin, and St. John's wort).
- History of haemorrhage within the past 6 months, including gross hemoptysis or hematuria.
- Requirement of anticoagulant therapy with oral vitamin K antagonists. Low-dose anticoagulants for maintenance of patency of central venous access devise or prevention of deep venous thrombosis is allowed. Therapeutic use of low molecular weight heparin is allowed.
- Active seizure disorder or evidence of brain metastases, spinal cord compression, or carcinomatous meningitis.
- A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment.
- Any of the following within the 12 months prior to study drug administration: myocardial infarction, uncontrolled angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack and 6 months for deep vein thrombosis or pulmonary embolism.
- Ongoing cardiac dysrhythmias of NCI CTCAE grade ≥2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
- Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- History of a malignancy (other than colorectal cancer) except those treated with curative intent for skin cancer (other than melanoma), in situ breast or in situ cervical cancer, or those treated with curative intent for any other cancer with no evidence of disease for 2 years.
- Dementia or significantly altered mental status that would prohibit the understanding or rendering of informed consent and compliance with the requirements of this protocol.
- Female patients who are pregnant or lactating, or men and women of reproductive potential not willing or not able to employ an effective method of birth control/contraception to prevent pregnancy during treatment and for 6 months after discontinuing study treatment. The definition of effective contraception should be in agreement with local regulation and based on the judgment of the principal investigator or a designated associate.
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Current, recent (within 4 weeks of the study treatment administration), or planned participation in an experimental therapeutic drug study other than this protocol.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Experimental
axitinib
|
5 mg BID taken orally with food continuously on Day 1 of the study.
One cycle corresponds to 28 days.
|
PLACEBO_COMPARATOR: control
placebo
|
will be administered orally with the same schedule of axitinib
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: 4 years
|
4 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse events
Time Frame: 4 years
|
4 years
|
overall survival
Time Frame: 4 years
|
4 years
|
overall response rate
Time Frame: 4 years
|
4 years
|
duration of disease response
Time Frame: 4 years
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Cristina Grávalos, MD, Hospital 12 de Octubre
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2012
Primary Completion (ACTUAL)
September 1, 2015
Study Completion (ACTUAL)
September 1, 2015
Study Registration Dates
First Submitted
November 29, 2011
First Submitted That Met QC Criteria
November 30, 2011
First Posted (ESTIMATE)
December 1, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
May 12, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Carcinoma
- Colorectal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Protein Kinase Inhibitors
- Axitinib
Other Study ID Numbers
- TTD-11-01
- 2011-002384-16 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Colorectal Carcinoma
-
Academic and Community Cancer Research UnitedNational Cancer Institute (NCI)Active, not recruitingStage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Recurrent Colorectal Carcinoma | Metastatic Colorectal Carcinoma | Refractory Colorectal CarcinomaUnited States
-
Emory UniversityBristol-Myers Squibb; National Cancer Institute (NCI); National Institutes of...Active, not recruitingColorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal CancerUnited States
-
Roswell Park Cancer InstituteNot yet recruitingPembrolizumab and Autologous Dendritic Cells for the Treatment of Refractory Colorectal Cancer (CRC)Recurrent Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Unresectable Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal CarcinomaUnited States
-
Wuhan Union Hospital, ChinaNot yet recruitingRecurrent Colorectal Carcinoma | Advanced Colorectal CarcinomaChina
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CompletedColorectal Neoplasms | Colorectal Cancer | Colorectal Adenoma | Colorectal Carcinoma | Colorectal Adenoma and CarcinomaNetherlands
-
Mayo ClinicCompletedMetastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Colorectal Carcinoma | Metastatic Rectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Metastatic... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Center for Advancing Translational Sciences (NCATS)Not yet recruitingRecurrent Colorectal Carcinoma | Locally Advanced Colorectal Carcinoma | Stage III Colorectal CancerUnited States
-
ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)RecruitingMetastatic Malignant Neoplasm in the Liver | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Unresectable Colorectal CarcinomaUnited States
-
National Cancer Institute (NCI)RecruitingUnresectable Malignant Solid Neoplasm | Metastatic Malignant Solid Neoplasm | Metastatic Colorectal Carcinoma | Stage IV Colorectal Cancer AJCC v8 | Unresectable Colorectal CarcinomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingMetastatic Colorectal Adenocarcinoma | Stage IV Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Metastatic Microsatellite Stable Colorectal Carcinoma | Advanced Microsatellite Stable Colorectal Carcinoma | Advanced Colorectal AdenocarcinomaUnited States
Clinical Trials on axitinib
-
PfizerCompletedNeoplasmsPoland, United States, Spain
-
Peking University Cancer Hospital & InstituteUnknownAdvanced Mucosal MelanomaChina
-
Acceleron Pharma Inc. (a wholly owned subsidiary...TerminatedAdvanced Renal Cell CarcinomaUnited States
-
PfizerCompletedLung Neoplasms | Carcinoma, Non-small Cell LungUnited States, Germany
-
PfizerCompletedCarcinoma, Renal CellUnited States, Spain, Japan, Germany, Czechia, Russian Federation
-
Chinese University of Hong KongCompleted
-
AkesoRecruitingRenal Cell Carcinoma | First-line TreatmentChina
-
University of Wisconsin, MadisonPfizerCompletedSolid Malignancies | Metastatic Castrate-resistant Prostate CancerUnited States
-
Assistance Publique - Hôpitaux de ParisPfizerCompletedcT2a N0NxM0 Renal TumorFrance
-
Bart NeynsPfizerCompleted