Metastatic Colorectal CancerPhase 2NCT00890305
Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone
A Phase 2 study testing CT-011 and FOLFOX in people with Metastatic Colorectal Cancer, run by Medivation, Inc. at 31 sites in 6 countries.
Trial summary
This clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Colorectal Cancer
- What is being tested?
- CT-011 and FOLFOX
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 31 sitesin 6 countries
- Study dates
- May 2009to Mar 2013
- Phase
- Phase 2
- 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
- Patient's age is 18 years or older, both genders.
- Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
- ECOG performance status ≤ 1
- At least 4 weeks from prior major surgery or radiotherapy.
- Life expectancy >3 months
- Hematology: ANC ≥ 1.5X109/L; Platelets >100x109/L.
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- Adequate Renal function
- Adequate Hepatic functions
- Normal Cardiac function
Who cannot join
- Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
- Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.
- Patients on concurrent anti cancer therapy other than that allowed in the study.
- Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
- Presence of clinically apparent or suspected brain metastasis.
- Patients who have had myocardial infarction, severe congestive heart failure, or significant arrhythmia within the past 6 months.
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- Serious active infection at the time of pre-study screening.
- Active or history of autoimmune disorders/conditions.
- Women who are pregnant or lactating
- Concurrent active malignancy.
- Ascites, pleural effusions, or osteoblastic bone metastases as the only site of disease.
- Other prior malignancies, except for cured or adequately treated malignancies for which there has been no evidence of activity for more than 5 years.
- Subjects with a condition which may interfere with the subjects' ability to understand the requirements of the study.
- Patients with history of life threatening allergic reactions to food or drugs
- Patients with symptomatic peripheral neuropathy> Grade 1.
- Known positive HIV, Hepatitis B surface antigen or Hepatitis C antibody.
Trial locations and contacts
31 sites in 6 countries.
31 sites in 6 countries
Romania8 sites
"Prof. Dr. Ion Chiricuţă" Institute of Oncology
Cluj-Napoca, 400015
Clinical Emergency Hospital - Oncology Department
Constanța, 900591
Oncolab SRL, No. 1
Craiova, 200535
Center of Medical Oncology
Iași
Clinical Hospital Pelican Oradea
Oradea, 410469
No. 1 City Hospital
Ploieşti
"Sf. Ioan cel Nou" Clinical Emergency County Hospital
Suceava
Clinic of Oncology - Radiotherapy
Tg. Mures, 540141
Bulgaria7 sites
MHAT "Dr. Tota Venkova"
Gabrovo
InterDistrict Dispensary in Oncology Diseases with Stationary-Ruse, EOOD
Rousse
InterDistrict Dispensary in Oncology Diseases with Stationary
Shumen
Multiprofile Hospital for Active Treatment "Tsaritza Joanna"
Sofia
Specialized Hospital for Active Treatment for Oncology
Sofia
InterDistrict Dispensary of Oncology Diseases with Stationary
Varna
Multiprofile Hospital for Active Treatment "Sv. Marina", EAD,
Varna
India6 sites
Cancer Clinic
Nagpur, Maharashtra, 440012
Curie Manavata Cancer Centre, Opp.
Nashik, Maharashtra, 422004
G. Kuppuswamy Naidu Memorial Hospital
Pappanaickenpalayam, Coimbatore, Tamil Nadu, 641037
Ruby Hall Clinic
Pune, Maharashtra, 411001
Deenanath Mangeshkar Hospital and Research Centre
Pune, Maharashtra, 411004
Regional Cancer Centre, Indira Gandhi Institute of Medical Sciences
Sheikhpura, Patna, Bihar, 800 014
United States5 sites
The Cancer Center of Huntsville, PC
Huntsville, Alabama, 35801
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
Signal Point Clinical Research Center
Middletown, Ohio, 45042
Memorial Sloan-Kettering Cancer Center
New York, New York, 10017
University of South Florida
Tampa, Florida, 33606
Peru3 sites
Hospital Almanzor Aguinaga Asenjo - Chiclayo
Chiclayo
Clinica Ricardo Palma
Lima
Hospital Regional nivel III Cayetano Heredia Essalud Piura
Piura
Puerto Rico2 sites
Ponce School of Medicine/CAIMED Center
Ponce, 00716
Fundacion de Investigacion de Diego
Santurce, 00909
About this study
Official title: Phase II Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone Administered Intravenously to Patients With Colorectal Adenocarcinoma Previously Untreated for Metastatic Disease
This clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone.
Read the detailed description
The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3mg/kg in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone. Approximately 168 patients are planned to be enrolled to this study.
- Conditions
- Metastatic Colorectal Cancer
- Being tested
- CT-011, FOLFOX
- Keywords
- Metastatic colorectal cancer, FOLFOX chemotherapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-011Drug
FOLFOXDrug
FOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days.
mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours).
| Study group | Role | What they receive |
|---|---|---|
| CT-011 in combination with FOLFOX | Experimental | CT-011 (3 mg/kg) administered intravenously every 4 weeks for 4 weeks and every 12 weeks thereafter until disease progression or maximum tolerance.
FOLFOX (FOLFOX4 or mFOLFOX6) administered 7 days after the first administration of CT-011 and repeated every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation. Receives: Drug: CT-011; Drug: FOLFOX |
| FOLFOX | Active comparator | FOLFOX (FOLFOX-4 or mFOLFOX6) administered every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation. Receives: Drug: FOLFOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone.
Measured: 32 months
Secondary outcomes (7)
Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011.
Measured: 32 months
Anti tumor activity of the antibody.
Measured: 32 months
Objective response rate by RECIST.
Measured: 32 months
Progression-free survival rates.
Measured: 32 months
Response duration.
Measured: 32 months
Overall survival.
Measured: 32 months
Tumor and immunological markers.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Colorectal CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leonard B Saltz, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00890305
- Sponsor's protocol ID
- CT-2008-01
- Other IDs
- 2009-014593-18, 2009
- Status last verified
- Jun 2015
- First submitted
- 28 Apr 2009
- Last updated
- 8 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study to Evaluate the Safety, Tolerability and Efficacy of FOLFOX + CT-011 Versus FOLFOX Alone Administered Intravenously to Patients With Colorectal Adenocarcinoma Previously Untreated for Metastatic Disease
- ClinicalTrials.gov ID
- NCT00890305
- Acronym / sponsor ID
- CT-2008-01
- Conditions
- Metastatic Colorectal Cancer
- Keywords
- Metastatic colorectal cancer, FOLFOX chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Medivation, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Apr 2009 (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 clinical trial will be performed in previously untreated patients with metastatic colorectal cancer. The study will evaluate the safety, tolerability and efficacy of the study drug, CT-011, in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone.
Detailed description
The proposed clinical trial will be a multi-center, randomized, open label, active control study in previously untreated patients with metastatic colorectal cancer aimed to evaluate the safety, tolerability and efficacy of the monoclonal antibody, CT-011, administered at 3mg/kg in combination with FOLFOX chemotherapy (FOLFOX4 or mFOLFOX6) compared with treatment by FOLFOX alone. Approximately 168 patients are planned to be enrolled to this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT-011 in combination with FOLFOX | Experimental | Drug: CT-011, Drug: FOLFOXCT-011 (3 mg/kg) administered intravenously every 4 weeks for 4 weeks and every 12 weeks thereafter until disease progression or maximum tolerance. FOLFOX (FOLFOX4 or mFOLFOX6) administered 7 days after the first administration of CT-011 and repeated every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation. |
| FOLFOX | Active comparator | Drug: FOLFOXFOLFOX (FOLFOX-4 or mFOLFOX6) administered every 14 days for up to 24 cycles. At the end of FOLFOX therapy, patients who have not progressed will be eligible for maintenance chemotherapy with 5-FU/leucovorin at the same dose and schedule until disease progression or study drug discontinuation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient's age is 18 years or older, both genders.
- Patients with metastatic disease who are eligible for first line FOLFOX chemotherapy. Adjuvant or neoadjuvant given at least 12 months prior for non-metastatic disease is permitted.
- ECOG performance status ≤ 1
- At least 4 weeks from prior major surgery or radiotherapy.
- Life expectancy >3 months
Key exclusion criteria (16 listed)
- Patients who had adjuvant or neoadjuvant therapy for non-metastatic disease given within the last 12 months.
- Patients who had received Oxaliplatin within 12 months prior to diagnosis of metastatic disease.
- Patients on concurrent anti cancer therapy other than that allowed in the study.
- Patients on concurrent steroids, other than those allowed for routine antiemetics, or inhaled steroids
- Presence of clinically apparent or suspected brain metastasis.
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 |
|---|---|---|
| CT-011 | Drug | CT-011 in combination with FOLFOX |
| FOLFOXFOLFOX-4: each cycle consists of the following: oxaliplatin 85 mg/m2 on Day 1, leucovorin 200 mg/m2/day on Day 1 and Day 2 followed by 5-FU 400 mg/m2 bolus and a 22 hour infusion of 5-FU 600 mg/m2 for two consecutive days. mFOLFOX-6: each cycle consists of the following: oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 on Day 1, followed by 5-FU 400 mg/m2 bolus, followed by 5-FU 1200 mg/m2/day for two consecutive days (total 2,400 mg/m2 over 46-48 hours). | Drug | CT-011 in combination with FOLFOX, FOLFOX |
Primary outcome
The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone.
Time frame: 32 months
7 secondary outcomes
Composite of safety, tolerability, pharmacokinetics and immunogenicity of CT-011.
Time frame: 32 months
Anti tumor activity of the antibody.
Time frame: 32 months
Objective response rate by RECIST.
Time frame: 32 months
Progression-free survival rates.
Time frame: 32 months
Response duration.
Time frame: 32 months
Overall survival.
Time frame: 32 months
Tumor and immunological markers.
Time frame: 32 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 8 Jul 2015.
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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.
Leonard B Saltz, MD principal investigator
Memorial Sloan Kettering Cancer Center
31 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT-011 and FOLFOX in people with Metastatic Colorectal Cancer, run by Medivation, Inc. at 31 sites in 6 countries.
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 9 inclusion and 16 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 8 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Romania, Bulgaria, India, United States, Peru and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The primary endpoint will be the median progression free survival in patients treated with CT-011 plus FOLFOX compared to that of patients treated with FOLFOX alone. (time frame: 32 months). 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 8 Jul 2015; AzTrials last refreshed its copy on 8 Nov 2026.