Colon AdenocarcinomaPhase 1/2NCT02393755
Nintedanib and Capecitabine in Treating Patients With Refractory Metastatic Colorectal Cancer
A Phase 1/2 study testing Capecitabine, Laboratory Biomarker Analysis and Nintedanib in people with Colon Adenocarcinoma and Rectal Adenocarcinoma, run by Roswell Park Cancer Institute at 2 sites in United States.
Trial summary
This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Adenocarcinoma, Rectal Adenocarcinoma, Recurrent Colon Carcinoma
- What is being tested?
- Capecitabine, Laboratory Biomarker Analysis and Nintedanib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2015to 18 May 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Hemoglobin >= 9 g/dL
- Absolute neutrophil count >= 1500/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine =< 1.5 upper limit of normal (ULN) AND creatinine clearance (CrCl) > 50 mL/min by Cockcroft-Gault equation
- Males = (140 -age (yrs) (body weight (kg)/(72) (serum creatinine) (mg/dL)
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- Females = 0.85 * (140-age (yrs) (body weight (kg)/(72)(serum creatinine (mg/dL)
- Bilirubin < ULN
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 1.5 ULN if without liver metastases
- AST/ALT =< 2.5 x ULN if with liver metastases
- Coagulation parameters: international normalized ratio (INR) =< 2, prothrombin time (PT) and partial thromboplastin time (PTT) < 1.5 X institutional ULN
- Have measurable disease per RECIST 1.1 criteria
- Histologically or cytologically proven adenocarcinoma of the colon or rectum
- Prior progression following a fluoropyrimidine-based therapy and progression following or intolerance to irinotecan and oxaliplatin, as well as anti-epidermal growth factor receptor (EGFR) therapy (e.g., panitumumab or cetuximab) for rat sarcoma viral oncogene homolog (RAS) wild-type patients
- Ability to swallow and retain oral medication
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for three months following completion of therapy; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately
- Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Who cannot join
- Prior treatment with nintedanib
- Prior treatment with regorafenib
- Major injuries or surgery within the 4 weeks prior to initiation of therapy with incomplete wound healing or planned surgery during the on-study treatment period
- Uncontrolled hypertension: systolic blood pressure >= 160, diastolic blood pressure >= 90
- Urine protein/creatinine ratio >= 1.0
- History of clinically significant hemorrhagic or thrombotic event within the past 6 months, not including uncomplicated catheter-associated venous thrombosis; patients on anti-coagulation are not permitted to be on any oral formulations (warfarin, rivaroxaban, dabigatran, etc.) due to concern for drug-drug interaction
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- Unstable angina, symptomatic congestive heart failure or cardiac arrhythmia requiring anti-arrhythmic therapy (beta-blockers, calcium channel blockers and digoxin are allowed)
- History of cerebrovascular or myocardial ischemia within 6 months of initiation
- Known inherited predisposition to bleeding or thrombosis
- Known active or chronic hepatitis B or C or human immunodeficiency virus (HIV)
- Untreated brain metastases
- History of second primary malignancy diagnosed within 3 years prior to enrollment, excluding:
- In-situ cervical carcinoma
- Superficial bladder cancer
- Non-melanoma skin cancer
- Stage I breast cancer
- Low grade (Gleason =< 6) localized prostate cancer
- Any additional malignancy which has been in clinical remission for at least 1 year
- Pregnant or nursing female participants
- Unwilling or unable to follow protocol requirements
- Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug
- Received an investigational agent within 4 weeks prior to enrollment
- PHASE I: History of intolerance to capecitabine at doses =< 1000 mg/m^2 BID, as defined by documented >= grade 3 hand-foot syndrome, documented severe diarrhea requiring hospitalization, or other documented severe adverse events (AEs) attributable to capecitabine
- PHASE II: History of intolerance to capecitabine at doses below 1000 mg/m^2 BID, as defined by documented >= grade 3 hand-foot syndrome; documented severe diarrhea requiring hospitalization; or other documented severe AEs attributable to capecitabine
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Roswell Park Cancer Institute
Buffalo, New York, 14263
City of Hope Comprehensive Cancer Center
Duarte, California, 91010
About this study
Official title: A Phase I/II Study of Nintedanib and Capecitabine in Refractory Metastatic Colorectal Cancer
This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nintedanib with capecitabine may be a better treatment for colorectal cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- I. To estimate the maximum tolerated dose (MTD) and examine the dose-limiting toxicities of nintedanib when administered with capecitabine within the study population and, establish the recommended phase II dose (RP2D). (Phase I)
- II. To assess progression free survival at 18 weeks. (Phase II)
SECONDARY OBJECTIVES:
- I. To assess median progression free survival. (Phase II)
- II. To assess median overall survival from the date of enrollment to the time of death will be documented. (Phase II)
- III. To assess the objective response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. (Phase II)
- IV. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0). (Phase II)
TERTIARY OBJECTIVES:
- I. Measurement of circulating angiogenic cytokines (CAFs): vascular endothelial growth factor (VEGF), soluble vascular endothelial growth factor receptor (sVEGFR) 1/2, placental growth factor (PlGF), granulocyte macrophage colony-stimulating factor (GMCSF), leptin, interleukin (IL)-1 alpha (a), IL-8, IL-6, fibroblast growth factor basic (FGFb), osteopontin and pentraxin-3. (Phase II)
- II. Measurement of drug levels and pharmacokinetic (PK)/pharmacodynamic (PD) modeling. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of nintedanib followed by a phase II study.
Patients receive capecitabine orally (PO) twice daily (BID) (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 28 days until resolution or satisfactory stabilization of persistent drug-related toxicity, and then every 6 months thereafter.
- Conditions
- Colon Adenocarcinoma, Rectal Adenocarcinoma, Recurrent Colon Carcinoma, Recurrent Rectal Carcinoma, Stage IVA Colon Cancer, Stage IVA Rectal Cancer
- Being tested
- Capecitabine, Laboratory Biomarker Analysis, Nintedanib, Pharmacological Study
- Medical subject headings
- Colonic Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CapecitabineDrug
Also called Ro 09-1978/000, Xeloda
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
NintedanibDrug
Also called BIBF 1120, BIBF-1120, Intedanib, Multitargeted Tyrosine Kinase Inhibitor BIBF 1120
Given PO
Correlative studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (capecitabine, nintedanib) | Experimental | Patients received capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeated every 21 days in the absence of disease progression or unacceptable toxicity. Receives: Drug: Capecitabine; Other: Laboratory Biomarker Analysis; Drug: Nintedanib; Other: Pharmacological Study |
| Treatment (capecitabine , nintendanib) | Experimental | Patients receive the highest safe dose of the combination of nintedanib and capcitabine. Receives: Drug: Nintedanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Examine the DLT
The recommended Phase II dose is of the Nintedanib and Capecitabine combination is defined as the dose level that causes dose limiting toxicities (DLTs) in ≤ 1 out of 6 patients at highest dose level below the maximally administered dose.
Capecitabine is fixed dose at 2000 mg/m2; while Nintedanib is evaluated at 150mg (dose level 1) and 200 mg (dose level 2).
Measured: At least 21 days.
Progression Free Survival (PFS) Rate, Defined as the Proportion of Patients Who Survive Without Disease Progression Via the RECIST Version 1.1 (Phase II)
Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm) or the appearance of new lesions.
Will be summarized using standard Kaplan-Meier methods.
Measured: At 18 weeks
Secondary outcomes (4)
Median PFS (Phase II)
Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm) or the appearance of new lesions. Estimates of median PFS will be obtained with corresponding 90% confidence intervals.
Measured: Up to 2 years
Median OS (Phase II)
Overall survival is defined as time from date of subject enrollment to the date of death due to any cause. Estimates of median OS will be obtained with corresponding 90% confidence intervals.
Measured: From the date of enrollment to the time of death, assessed up to 2 years
Objective Response Rate
Overall Response is defined as Complete Response: Disappearance of all target lesions and any lymph nodes must have a reduction in short axis to < 10 mm; or Partial Response: At least a 30% decrease in the sum of diameters of target lesions; or Stable Disease: Neither sufficient shrinkage to qualify for partial response, nor sufficient increase to qualify for progressive disease.
Measured: After every 3 cycles (9 weeks) of therapy.
Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II)
Number of Participants with Adverse Events, Graded According to the CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE Version 4.0).
Measured: Up to 30 days after the last dose of study drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study start8 May 2015
- Primary completion1 Nov 2017
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Boehringer Ingelheim, National Comprehensive Cancer Network
- Responsible party
- Sponsor
- Investigators
- Christos Fountzilas, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393755
- Sponsor's protocol ID
- I 265514
- Other IDs
- NCI-2015-00223, I 265514, P30CA016056
- Status last verified
- Jul 2021
- First submitted
- 13 Mar 2015
- Last updated
- 8 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Boland PM, Ebos JML, Attwood K, Mastri M, Fountzilas C, Iyer RV, Banker C, Goey AKL, Bies R, Ma WW, Fakih M. A phase I/II study of nintedanib and capecitabine for refractory metastatic colorectal cancer. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae017. doi: 10.1093/jncics/pkae017.
PubMed 38697618
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Nintedanib and Capecitabine in Refractory Metastatic Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02393755
- Acronym / sponsor ID
- I 265514
- Conditions
- Colon Adenocarcinoma, Rectal Adenocarcinoma, Recurrent Colon Carcinoma, Recurrent Rectal Carcinoma, Stage IVA Colon Cancer, Stage IVA Rectal Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Boehringer Ingelheim, National Comprehensive Cancer Network
- Study start
- 8 May 2015 (actual)
- Primary completion
- 1 Nov 2017 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Posted 7 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I/II trial studies the side effects and best dose of nintedanib when given together with capecitabine and to see how well they work in treating patients with colorectal cancer that has not responded to previous treatment (refractory) and has spread to other places in the body (metastatic). Nintedanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also block the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nintedanib with capecitabine may be a better treatment for colorectal cancer.
Detailed description
PRIMARY OBJECTIVES:
- I. To estimate the maximum tolerated dose (MTD) and examine the dose-limiting toxicities of nintedanib when administered with capecitabine within the study population and, establish the recommended phase II dose (RP2D). (Phase I)
- II. To assess progression free survival at 18 weeks. (Phase II)
SECONDARY OBJECTIVES:
- I. To assess median progression free survival. (Phase II)
- II. To assess median overall survival from the date of enrollment to the time of death will be documented. (Phase II)
- III. To assess the objective response rate as measured by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1. (Phase II)
- IV. To assess the toxicity of dose regimen using the Cancer Therapy Evaluation Program (CTEP) National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.0). (Phase II)
TERTIARY OBJECTIVES:
- I. Measurement of circulating angiogenic cytokines (CAFs): vascular endothelial growth factor (VEGF), soluble vascular endothelial growth factor receptor (sVEGFR) 1/2, placental growth factor (PlGF), granulocyte macrophage colony-stimulating factor (GMCSF), leptin, interleukin (IL)-1 alpha (a), IL-8, IL-6, fibroblast growth factor basic (FGFb), osteopontin and pentraxin-3. (Phase II)
- II. Measurement of drug levels and pharmacokinetic (PK)/pharmacodynamic (PD) modeling. (Phase II)
OUTLINE: This is a phase I, dose-escalation study of nintedanib followed by a phase II study.
Patients receive capecitabine orally (PO) twice daily (BID) (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days, every 28 days until resolution or satisfactory stabilization of persistent drug-related toxicity, and then every 6 months thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment (capecitabine, nintedanib) | Experimental | Drug: Capecitabine, Other: Laboratory Biomarker Analysis, Drug: Nintedanib, Other: Pharmacological StudyPatients received capecitabine PO BID (every 12 hours) on days 1-14 and nintedanib PO BID (every 12 hours) on days 1-21. Courses repeated every 21 days in the absence of disease progression or unacceptable toxicity. |
| Treatment (capecitabine , nintendanib) | Experimental | Drug: NintedanibPatients receive the highest safe dose of the combination of nintedanib and capcitabine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Hemoglobin >= 9 g/dL
- Absolute neutrophil count >= 1500/mm^3
- Platelet count >= 100,000/mm^3
- Creatinine =< 1.5 upper limit of normal (ULN) AND creatinine clearance (CrCl) > 50 mL/min by Cockcroft-Gault equation
Key exclusion criteria (24 listed)
- Prior treatment with nintedanib
- Prior treatment with regorafenib
- Major injuries or surgery within the 4 weeks prior to initiation of therapy with incomplete wound healing or planned surgery during the on-study treatment period
- Uncontrolled hypertension: systolic blood pressure >= 160, diastolic blood pressure >= 90
- Urine protein/creatinine ratio >= 1.0
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 |
|---|---|---|
| CapecitabineAlso: Ro 09-1978/000, XelodaGiven PO | Drug | Treatment (capecitabine, nintedanib) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (capecitabine, nintedanib) |
| NintedanibAlso: BIBF 1120, BIBF-1120, Intedanib, Multitargeted Tyrosine Kinase Inhibitor BIBF 1120Given PO | Drug | Treatment (capecitabine , nintendanib), Treatment (capecitabine, nintedanib) |
| Pharmacological StudyCorrelative studies | Other | Treatment (capecitabine, nintedanib) |
Primary outcome
To Examine the DLT
Time frame: At least 21 days.
The recommended Phase II dose is of the Nintedanib and Capecitabine combination is defined as the dose level that causes dose limiting toxicities (DLTs) in ≤ 1 out of 6 patients at highest dose level below the maximally administered dose. Capecitabine is fixed dose at 2000 mg/m2; while Nintedanib is evaluated at 150mg (dose level 1) and 200 mg (dose level 2).
Progression Free Survival (PFS) Rate, Defined as the Proportion of Patients Who Survive Without Disease Progression Via the RECIST Version 1.1 (Phase II)
Time frame: At 18 weeks
Progressive disease is defined as at least a 20% increase in the sum of diameters of target lesions (the sum must also demonstrate an absolute increase of at least 5 mm) or the appearance of new lesions. Will be summarized using standard Kaplan-Meier methods.
4 secondary outcomes
Median PFS (Phase II)
Time frame: Up to 2 years
Median OS (Phase II)
Time frame: From the date of enrollment to the time of death, assessed up to 2 years
Objective Response Rate
Time frame: After every 3 cycles (9 weeks) of therapy.
Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II)
Time frame: Up to 30 days after the last dose of study drug
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38697618Boland PM, Ebos JML, Attwood K, Mastri M, Fountzilas C, Iyer RV, Banker C, Goey AKL, Bies R, Ma WW, Fakih M. A phase I/II study of nintedanib and capecitabine for refractory metastatic colorectal cancer. JNCI Cancer Spectr. 2024 Apr 30;8(3):pkae017. doi: 10.1093/jncics/pkae017.
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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.
Christos Fountzilas principal investigator
Roswell Park Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Capecitabine, Laboratory Biomarker Analysis and Nintedanib in people with Colon Adenocarcinoma and Rectal Adenocarcinoma, run by Roswell Park Cancer Institute 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 17 inclusion and 24 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 2021. 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 combined 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.
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?
Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Examine the DLT (time frame: At least 21 days.). The study lists 2 primary outcomes in all. 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 NCT02393755, 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 8 Jul 2021; AzTrials last refreshed its copy on 8 Nov 2026.