18 and older, any sex, with Colon Adenocarcinoma or Rectal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To Examine the DLTPrimary· 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).
Group
Value
95% CI
Treatment (Capecitabine, Nintedanib)
200
Progression Free Survival (PFS) Rate, Defined as the Proportion of Patients Who Survive Without Disease Progression Via the RECIST Version 1.1 (Phase II)Primary· 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.
Group
Value
95% CI
Treatment (Capecitabine, Nintedanib)
41.7
29.2 – 55.3
Median PFS (Phase II)Secondary· Up to 2 years
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.
Group
Value
95% CI
Treatment (Capecitabine, Nintedanib)
3.4
2.1 – 4.2
Median OS (Phase II)Secondary· From the date of enrollment to the time of death, assessed up to 2 years
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.
Group
Value
95% CI
Treatment (Capecitabine, Nintedanib)
8.9
5.9 – 13.8
Objective Response RateSecondary· After every 3 cycles (9 weeks) of therapy.
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.
Group
Value
95% CI
Treatment (Capecitabine, Nintedanib)
58.3
44.7 – 70.8
Aggregate Rates of Adverse Events Measured by CTCAE Version 4.0 (Phase II)Secondary· Up to 30 days after the last dose of study drug
Number of Participants with Adverse Events, Graded According to the CTEP NCI Common Terminology Criteria for Adverse Events (CTCAE Version 4.0).
Group
Value
95% CI
Treatment (Capecitabine, Nintedanib)
3
Treatment (Capecitabine, Nintedanib)
13
Treatment (Capecitabine, Nintedanib)
16
Treatment (Capecitabine, Nintedanib)
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Day 1 of all Cycles, Cycle 1 Day 8 and Cycle 2 Day 8 (for phase 1 only), End of Treatment, an average of 102 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Dose Level 1: Capecitabine at 2000 mg/m2, Nintedanib at 150 mg
Serious: 0/3 (0%)
Deaths: 3/3
Dose Level 2: Capecitabine at 2000 mg/m2,Nintedanib at 200 mg
Serious: 10/39 (26%)
Deaths: 32/39
Serious adverse events (15 terms)
Reaction
System
Dose Level 1: Capecitabine…
Dose Level 2: Capecitabine…
Abdominal pain
Gastrointestinal disorders
—
—
Constipation
Gastrointestinal disorders
—
—
Intestinal perforation
Gastrointestinal disorders
—
—
Small intestinal obstruction
Gastrointestinal disorders
—
—
Hepatic failure
Hepatobiliary disorders
—
—
Gastroenteritis
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Alanine aminotransferase increased
Investigations
—
—
Dehydration
Metabolism and nutrition disorders
—
—
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Neoplasm malignant
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Mental status changes
Psychiatric disorders
—
—
Urinary retention
Renal and urinary disorders
—
—
Pleural effusion
Respiratory, thoracic and mediastinal disorders
—
—
Respiratory failure
Respiratory, thoracic and mediastinal disorders
—
—
Other adverse events (150 terms — click to expand)
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07469306 — Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer
· Phase 2
· not yet recruiting
NCT07494448 — Phase Ib/II Study of Zanidatamab Plus Tucatinib and Chemotherapy in HER2-Positive Advanced Breast Cancer
· Phase 1, PHASE2
· not yet recruiting
NCT07521605 — Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer
· Phase 2
· not yet recruiting
NCT06622057 — D07001 Softgel-Capsules and Capecitabine Combination Therapy in Patients With Advanced Biliary Tract Cancer
· Phase 3
· not yet recruiting
NCT07340567 — Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test
· Phase 3
· not yet recruiting
Other recruiting trials for Colon Adenocarcinoma
Currently open trials in the same condition.
NCT07468630 — Tolecizumab Plus Chemoimmunotherapy for pMMR/MSS Locally Advanced Colon Adenocarcinoma
· Phase 2
· recruiting
NCT06997497 — A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-108
· Phase 3
· recruiting
NCT06652672 — Sentinel Node and Organ-sparing Surgery in Stage I Colon Carcinoma
· NA
· recruiting
NCT06709885 — HDAC Inhibitor Combination With Chemoimmunotherapy in the Neoadjuvant Treatment of pMMR Locally Advanced Colon Cancer
· Phase 2
· recruiting
NCT06640166 — Encorafenib + Cetuximab Beyond Progression in Combination With FOLFIRI in Patients With BRAF V600E Mutated Metastatic Co
· Phase 2
· recruiting
Other Roswell Park Cancer Institute trials
Trials by the same sponsor.
NCT07489287 — GB-5267 for the Treatment Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer
· Phase 1
· not yet recruiting
NCT06943664 — Photoimmunotherapy With ASP-1929 and Cemiplimab for the Treatment of Refractory, Inoperable, and Metastatic Stage IIIB-I
· Phase 2
· not yet recruiting
NCT06827054 — Psilocybin With Psychotherapy for Improving Chronic Pain in Cancer Patients Requiring Opioids
· Phase 2
· not yet recruiting
NCT06334016 — Evaluating the Delivery and Effects of THC Vaping Liquids in the Bloodstream
· EARLY_PHASE1
· not yet recruiting
NCT06670976 — Propranolol Plus Standard Radiation Therapy Before Surgery for the Treatment of Patients With Soft Tissue Sarcoma
· Phase 1
· withdrawn
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Roswell Park Cancer Institute
Last refreshed: 8 July 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02393755.