Last reviewed · How we verify
Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer
Phase 2 trial testing Erlotinib in Attenuated Familial Adenomatous Polyposis in 46 participants. Completed in 27 September 2021.
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 46 |
| Start date | 27 October 2017 |
| Primary completion | 23 February 2020 |
| Estimated completion | 27 September 2021 |
| Sites | 8 locations across Puerto Rico, United States |
National Cancer Institute (NCI)
Adults 18 to 69, any sex, with Attenuated Familial Adenomatous Polyposis or Familial Adenomatous Polyposis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Assessed by esophagogastroduodenoscopy, the mean percent change was calculated by subtracting the sum of diameters from all polyps at baseline from the sum of diameters of all polyps at 6 months, then dividing by the sum of diameters from all polyps at baseline and multiplying by 100.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Erlotinib Hydrochloride) | -29.6 | -39.6 – -19.7 |
Assessed according to National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The number of patients reporting a grade 2 or higher event are reported.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Erlotinib Hydrochloride) | 33 |
Assessed according to NCI CTCAE version 4.0. All registered and treated participants will be evaluable for AEs from the time of their first dose of weekly erlotinib treatment. To evaluate the AE profile for this treatment, the maximum grade for each type of adverse event will be recorded for each participant and frequency tables will be reviewed to determine the overall patterns. The number of patients reporting a grade 1 or higher adverse event at least possibly related to treatment are reported.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Erlotinib Hydrochloride) | 41 |
The number of duodenal polyps at baseline and the number of polyps remaining after 6 months of treatment will collected. The change in duodenal polyp number will be calculated for each patient by subtracting the baseline number of polyps from the 6 month number. Therefore a negative value indicates a decrease in the number of polyps present after 6 months. The median difference and standard deviation is reported.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Erlotinib Hydrochloride) | -12.8 | ± 22.96 |
Lower GI polyp burden was defined using the Pouch Exam form as either 1) the average diameter reported for pouch for participants with ileal pouch-anal anastomosis (IPAA), or 2) the average diameter reported for rectum for participants with ileorectal anastomosis (IRA) + rectal stump. Absolute change from baseline to month 6 are reported here.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Erlotinib Hydrochloride) | 0 | 0 – 1 |
Lower GI polyp burden was defined using the Pouch Exam form as either 1) the average diameter reported for pouch for participants with ileal pouch-anal anastomosis (IPAA), or 2) the average diameter reported for rectum for participants with ileorectal anastomosis (IRA) + rectal stump. The percent change from baseline to month 6 are reported here.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Erlotinib Hydrochloride) | 0 | 0 – 25.0 |
Lower GI polyp number was defined using the Pouch Exam form as either 1) the number of polyps reported for pouch for participants with ileal pouch-anal anastomosis (IPAA), or 2) the number of polyps reported for rectum for participants with ileorectal anastomosis (IRA) + rectal stump. Absolute change from baseline to month 6 are reported here.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Erlotinib Hydrochloride) | -6 | -26.0 – 0.0 |
Lower GI polyp number was defined using the Pouch Exam form as either 1) the number of polyps reported for pouch for participants with IPAA, or 2) the number of polyps reported for rectum for participants with IRA + rectal stump.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Erlotinib Hydrochloride) | -30.8 | -47.4 – 0.0 |
Time frame: Adverse events were collected monthly for up to 7 months from registration.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Treatment (Erlotinib Hydro… |
|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Reproductive system and breast -Oth spec | Reproductive system and breast disorders | — |
| Reaction | System | Treatment (Erlotinib Hydro… |
|---|---|---|
| Rash acneiform | Skin and subcutaneous tissue disorders | — |
| Diarrhea | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Headache | Nervous system disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Dizziness | Nervous system disorders | — |
| Dyspepsia | Gastrointestinal disorders | — |
| Alopecia | Skin and subcutaneous tissue disorders | — |
| Skin and subcut tissue disord - Oth spec | Skin and subcutaneous tissue disorders | — |
| Flu like symptoms | General disorders | — |
| Gen disord and admin site conds-Oth spec | General disorders | — |
| Malaise | General disorders | — |
| Anorexia | Metabolism and nutrition disorders | — |
| Resp, thoracic, mediastinal - Oth spec | Respiratory, thoracic and mediastinal disorders | — |
| Dry skin | Skin and subcutaneous tissue disorders | — |
| Pruritus | Skin and subcutaneous tissue disorders | — |
| Abdominal pain | Gastrointestinal disorders | — |
| Flatulence | Gastrointestinal disorders | — |
| Gastrointestinal disorders - Oth spec | Gastrointestinal disorders | — |
| Mucositis oral | Gastrointestinal disorders | — |
| Infections and infestations - Oth spec | Infections and infestations | — |
| Sinusitis | Infections and infestations | — |
| Musculoskeletal, conn tissue - Oth spec | Musculoskeletal and connective tissue disorders | — |
| Insomnia | Psychiatric disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Palpitations | Cardiac disorders | — |
| Dry eye | Eye disorders | — |
| Gastritis | Gastrointestinal disorders | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — |
| Oral pain | Gastrointestinal disorders | — |
| Non-cardiac chest pain | General disorders | — |
| Pain | General disorders | — |
| Immune system disorders - Other, specify | Immune system disorders | — |
| Bronchial infection | Infections and infestations | — |
| Enterocolitis infectious | Infections and infestations | — |
| Urinary tract infection | Infections and infestations | — |
| Dehydration | Metabolism and nutrition disorders | — |
Most-reported serious reactions: Small intestinal obstruction, Back pain, Reproductive system and breast -Oth spec.
Data from ClinicalTrials.gov NCT02961374 adverse events section.
This phase II trial studies the side effects of erlotinib hydrochloride and how well it works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Trials by the same sponsor.
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/NCT02961374.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing