NCT03251378 is a Phase 1 clinical trial of Fruquintinib (HMPL-013) in Advanced Solid Tumors, sponsored by Hutchison Medipharma Limited.

Who is sponsoring NCT03251378?

NCT03251378 is sponsored by Hutchison Medipharma Limited.

What drugs are being tested in NCT03251378?

Interventions in NCT03251378: Fruquintinib (HMPL-013).

What condition does NCT03251378 study?

NCT03251378 studies Advanced Solid Tumors, Metastatic Colon Cancer, Metastatic Breast Cancer, Triple Negative Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Breast Carcinoma, Rectal Cancer.

Is NCT03251378 still recruiting?

NCT03251378 is currently completed. Last updated 25 September 2024.

Are results published for NCT03251378?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-09-25 · How we verify

NCT03251378

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Multi-Center, Open-Label Study of Fruquintinib in Solid Tumors and Colorectal, and Breast Cancers

Completed Phase 1 Results posted Last updated 25 September 2024

What this trial tests

Phase 1 trial testing Fruquintinib (HMPL-013) in Advanced Solid Tumors in 129 participants. Completed in 30 March 2023.

Timeline

11 December 2017

Primary endpoint
13 December 2022

30 March 2023

Quick facts

Lead sponsor	Hutchison Medipharma Limited
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	129
Start date	11 December 2017
Primary completion	13 December 2022
Estimated completion	30 March 2023
Sites	9 locations across United States

Drugs / interventions tested

Fruquintinib (HMPL-013) — full drug profile →

Conditions studied

Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
Metastatic Colon Cancer — all drugs for Metastatic Colon Cancer →
Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
Triple Negative Breast Cancer — all drugs for Triple Negative Breast Cancer →

Sponsor

Hutchison Medipharma Limited — full company profile →

Who can join

18 and older, any sex, with Advanced Solid Tumors or Metastatic Colon Cancer. 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.

Dose Escalation Phase: Number of Participants With Dose-limiting Toxicities (DLTs) Primary · Cycle 1 (cycle length equal to [=] 28 days)

Dose-limiting toxicity was defined as: Any Grade 4 non-hematologic toxicity; Any Grade 3 non-hematologic toxicity related to study drug except for nausea/vomiting, diarrhea, constipation, hypertension, and electrolyte imbalances downgraded within 3-days with appropriate supportive treatment; Grade 4 neutropenia lasting \>3 days; Grade 3 febrile neutropenia (absolute neutrophil count \[ANC\] \<1.0\*10\^9 per liter \[/L\] with a single temperature of greater than (\>) 38.3 degree centigrade (°C) or a sustained temperature of greater than or equal to (\>=) 38°C for more than 1 hour); Grade 4 thro

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	1
Dose Escalation Phase: Fruquintinib 5 mg	0

Dose Escalation Phase: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs Primary · From first dose of study drug up to 37 days after last dose of study drug (i.e., up to 29 months)

TEAEs were defined as AEs that started or worsened in severity on or after the first dose of study medication and no later than 37 days after the date of last study treatment. A serious adverse event (SAE) was any AE that had any of the following characteristics: Fatal (that was, the AE actually caused or led to death, except for deaths caused by the progress of disease); Life threatening (that was, AE, in view of the investigator, places participant at immediate risk of death); Required or prolonged inpatient hospitalization (excluding emergency or outpatient treatment); Resulted in persisten

Participants with TEAEs

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	7
Dose Escalation Phase: Fruquintinib 5 mg	7

Participants with serious TEAEs

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	3
Dose Escalation Phase: Fruquintinib 5 mg	2

Dose Expansion Phase: Progression Free Survival (PFS) Rate Primary · From the first dose of study drug to disease progression, or death, whichever occurred first (i.e., up to 29 months)

PFS was defined as time from date of first dosing until date of an objective disease progression (PD) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 or death due to any cause, whichever comes first. PFS was determined using all data until last evaluable visit prior to or on date of: (i) radiographic PD per RECIST v1.1; (ii) withdrawal of consent to obtain additional scans on study; or (iii) initiation of subsequent anticancer therapy other than study drugs, whichever was earlier. PFS rate was defined as probability of being disease progression free at selec

Group	Value	95% CI
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	53.33	4.68 – 100.00
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	61.04	45.59 – 76.49
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	55.64	39.87 – 71.41
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	29.30	1.91 – 56.70
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	38.46	12.02 – 64.91

Dose Escalation and Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of Fruquintinib Secondary · Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1, 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1 and 14 of Cycle 1 (Cycle 1 length=28 days)

Cmax of fruquintinib was reported.

Cycle 1 Day 1

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	52.2	± 24.2
Dose Escalation Phase: Fruquintinib 5 mg	114	± 27.5
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	96.0	± 23.0
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	85.2	± 32.1
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	89.0	± 43.2
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	104	± 37.0
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	105	± 36.5

Cycle 1 Day 14

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	198	± 9.8
Dose Escalation Phase: Fruquintinib 5 mg	403	± 33.7
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	336	± 50.9
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	271	± 26.5
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	293	± 27.1
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	331	± 36.1
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	352	± 23.4

Cycle 1 Day 21

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	205	± 12.8
Dose Escalation Phase: Fruquintinib 5 mg	390	± 19.1
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	238	± NA

Dose Escalation and Expansion Phase: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Fruquintinib Secondary · Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1, 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1 and 14 of Cycle 1 (Cycle 1 length=28 days)

Tmax of fruquintinib over a dosing intervals were reported.

Cycle 1 Day 1

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	2.07	1.03 – 21.2
Dose Escalation Phase: Fruquintinib 5 mg	1.95	0.917 – 25.0
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	1.96	1.00 – 13.8
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	2.25	0.917 – 23.8
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	2.04	0.983 – 2.04
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	2.00	1.00 – 18.4
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	2.01	1.75 – 23.9

Cycle 1 Day 14

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	1.03	0.967 – 1.92
Dose Escalation Phase: Fruquintinib 5 mg	2.00	1.97 – 7.05
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	1.52	1.00 – 2.03
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	2.03	0.00 – 26.1
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	2.00	0.933 – 7.18
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	1.86	0.917 – 7.00
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	1.84	0.933 – 7.00

Cycle 1 Day 21

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	1.83	0.917 – 1.98
Dose Escalation Phase: Fruquintinib 5 mg	2.00	1.88 – 4.08
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	1.00	NA – NA

Dose Escalation and Expansion Phase: Minimum Observed Plasma Concentration (Cmin) of Fruquintinib Secondary · Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)

Cmin of fruquintinib was reported.

Cycle 1 Day 14

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	138	± 28.3
Dose Escalation Phase: Fruquintinib 5 mg	281	± 101
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	251	± 114
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	193	± 57.3
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	204	± 63.2
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	227	± 98.4
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	249	± 72.1

Cycle 1 Day 21

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	140	± 27.0
Dose Escalation Phase: Fruquintinib 5 mg	283	± 81.0
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	182	± NA

Dose Escalation and Expansion Phase: Time to Reach Minimum Observed Plasma Concentration (Tmin) of Fruquintinib Secondary · Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)

Tmin of fruquintinib was reported.

Cycle 1 Day 14

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	0.00	0.00 – 7.00
Dose Escalation Phase: Fruquintinib 5 mg	0.508	0.00 – 27.8
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	3.57	0.00 – 7.13
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	0.00	0.00 – 25.6
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	0.00	0.00 – 28.2
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	0.00	0.00 – 23.9
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	0.458	0.00 – 22.0

Cycle 1 Day 21

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	7.00	0.00 – 25.6
Dose Escalation Phase: Fruquintinib 5 mg	3.54	0.00 – 24.9
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	7.00	NA – NA

Dose Escalation and Expansion Phase: Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours (AUC0-24) of Fruquintinib Secondary · Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1, 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 1 and 14 of Cycle 1 (Cycle 1 length=28 days)

AUC0-24 of fruquintinib was reported.

Cycle 1 Day 1

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	912	± 21.5
Dose Escalation Phase: Fruquintinib 5 mg	2010	± 19.2
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	1340	± 25.6
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	1384	± 39.0
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	1550	± 46.5
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	1821	± 31.5
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	1739	± 39.8

Cycle 1 Day 14

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	3694	± 17.1
Dose Escalation Phase: Fruquintinib 5 mg	8249	± 35.2
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	6507	± 53.7
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	5338	± 28.9
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	5833	± 27.3
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	6135	± 40.1
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	6957	± 25.1

Cycle 1 Day 21

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	3731	± 22.5
Dose Escalation Phase: Fruquintinib 5 mg	7740	± 26.7
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	4995	± NA

Dose Escalation and Expansion Phase: Apparent Clearance at Steady State (CL/Fss) of Fruquintinib Secondary · Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14, and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)

CL/Fss was calculated as Dose/AUC0-t. As planned, CL/Fss was assessed at Cycle 1 Days 14 and 21 after multiple dose administration in Dose Escalation Phase and Cohort A of Dose Expansion Phase; and at Cycle 1 Day 14 for Cohort B, C, D, E of Expansion Phase.

Cycle 1 Day 14

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	14.4	± 2.90
Dose Escalation Phase: Fruquintinib 5 mg	11.1	± 4.04
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	14.1	± 7.31
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	16.3	± 5.16
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	14.8	± 3.92
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	14.7	± 7.18
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	12.3	± 2.80

Cycle 1 Day 21

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	14.1	± 3.07
Dose Escalation Phase: Fruquintinib 5 mg	11.3	± 2.83
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	17.5	± NA

Dose Escalation and Expansion Phase: Accumulation Ratio Based on Cmax of Fruquintinib Secondary · Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14 and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)

Accumulation ratio based on Cmax for Cycle 1 Day 14 was calculated as Day 14 Cmax /Day 1 Cmax and for Cycle 1 Day 21 was calculated as Day 21 Cmax /Day 1 Cmax. Accumulation ratio based on Cmax of fruquintinib was reported.

Cycle 1 Day 14

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	4.06	± 1.42
Dose Escalation Phase: Fruquintinib 5 mg	3.66	± 1.42
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	3.57	± 0.232
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	3.32	± 1.21
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	3.44	± 1.36
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	3.22	± 1.38
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	3.40	± 0.963

Cycle 1 Day 21

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	4.22	± 1.45
Dose Escalation Phase: Fruquintinib 5 mg	3.47	± 1.22
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	3.40	± NA

Dose Escalation and Expansion Phase: Accumulation Ratio Based on AUC0-24 Hours of Fruquintinib Secondary · Dose Escalation and Cohort A of Expansion Phases: Predose, 1, 2, 4, 8, 24 hours post-dose on Days 14 and 21 of Cycle 1; Cohorts B, C, D, E of Expansion Phase: Predose, 1, 2, 4, 8, 24 hours post-dose on Day 14 of Cycle 1 (Cycle 1 length=28 days)

Accumulation ratio for Cycle 1 Day 14 was calculated as AUC0-24 at Day 14 divided by AUC0-24h at Day 1, and for Cycle 1 Day 21 was calculated as AUC0-24 at Day 21 divided by AUC0-24 at Day 1. Accumulation ratio based on AUC0-24 of fruquintinib was reported.

Cycle 1 Day 14

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	4.24	± 1.21
Dose Escalation Phase: Fruquintinib 5 mg	4.19	± 1.19
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	4.04	± NA
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	3.87	± 1.22
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	4.38	± 3.08
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	3.73	± 1.51
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	4.37	± 1.70

Cycle 1 Day 21

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	4.36	± 1.53
Dose Escalation Phase: Fruquintinib 5 mg	3.90	± 0.964
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	4.43	± NA

Dose Escalation and Expansion Phase: Objective Response Rate (ORR) Secondary · From the first dose of study drug until first documentation of best overall response (i.e., up to 29 months)

ORR was defined as the percentage of participants with objective complete response (CR) or partial response (PR) response per RECIST version 1.1. As per RECIST 1.1; CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR was defined at least a 30 percent (%) decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

Group	Value	95% CI
Dose Escalation Phase: Fruquintinib 3 mg	16.7	0.42 – 64.12
Dose Escalation Phase: Fruquintinib 5 mg	14.3	0.36 – 57.87
Dose Expansion Phase, Cohort A: Fruquintinib 5 mg	0.0	0.00 – 45.93
Dose Expansion Phase, Cohort B: Fruquintinib 5 mg	2.4	0.06 – 12.86
Dose Expansion Phase, Cohort C: Fruquintinib 5 mg	5.1	0.63 – 17.32
Dose Expansion Phase, Cohort D: Fruquintinib 5 mg	0.0	0.00 – 30.85
Dose Expansion Phase, Cohort E: Fruquintinib 5 mg	0.0	0.00 – 24.71

Adverse events — posted to ClinicalTrials.gov

Time frame: From first dose of study drug up to 37 days after last dose of study drug (i.e., up to 29 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Dose Escalation Phase: Fruquintinib 3 mg

Serious: 3/7 (43%)

Deaths: 3/7

Dose Escalation Phase: Fruquintinib 5 mg

Serious: 2/7 (29%)

Deaths: 2/7

Dose Expansion Phase, Cohort A: Fruquintinib 5 mg

Serious: 4/6 (67%)

Deaths: 3/6

Dose Expansion Phase, Cohort B: Fruquintinib 5 mg

Serious: 19/41 (46%)

Deaths: 30/41

Dose Expansion Phase, Cohort C: Fruquintinib 5 mg

Serious: 14/40 (35%)

Deaths: 25/40

Dose Expansion Phase, Cohort D: Fruquintinib 5 mg

Serious: 2/14 (14%)

Deaths: 12/14

Dose Expansion Phase, Cohort E: Fruquintinib 5 mg

Serious: 4/14 (29%)

Deaths: 12/14

Serious adverse events (49 terms)

Reaction	System	Dose Escalation Phase: Fru…	Dose Escalation Phase: Fru…	Dose Expansion Phase, Coho…	Dose Expansion Phase, Coho…	Dose Expansion Phase, Coho…	Dose Expansion Phase, Coho…	Dose Expansion Phase, Coho…
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Pneumonia	Infections and infestations	—	—	—	—	—	—	—
Small intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—
Mental status changes	Psychiatric disorders	—	—	—	—	—	—	—
Acquired oesophageal web	Gastrointestinal disorders	—	—	—	—	—	—	—
Large intestinal obstruction	Gastrointestinal disorders	—	—	—	—	—	—	—
Breast cellulitis	Infections and infestations	—	—	—	—	—	—	—
Osteomyelitis	Infections and infestations	—	—	—	—	—	—	—
Embolic stroke	Nervous system disorders	—	—	—	—	—	—	—
Hypertension	Vascular disorders	—	—	—	—	—	—	—
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—
Dysphagia	Gastrointestinal disorders	—	—	—	—	—	—	—
Gastric ulcer perforation	Gastrointestinal disorders	—	—	—	—	—	—	—
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—	—	—	—
Oesophagitis	Gastrointestinal disorders	—	—	—	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—	—	—	—
Sepsis	Infections and infestations	—	—	—	—	—	—	—
Cholecystitis infective	Infections and infestations	—	—	—	—	—	—	—
COVID-19	Infections and infestations	—	—	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—	—	—
Kidney infection	Infections and infestations	—	—	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—

Other adverse events (221 terms — click to expand)

Reaction	System	Dose Escalation Phase: Fru…	Dose Escalation Phase: Fru…	Dose Expansion Phase, Coho…	Dose Expansion Phase, Coho…	Dose Expansion Phase, Coho…	Dose Expansion Phase, Coho…	Dose Expansion Phase, Coho…
Hypertension	Vascular disorders	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Dysphonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—	—	—
Hyponatraemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Hypertriglyceridaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—
Hypothyroidism	Endocrine disorders	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—
Weight decreased	Investigations	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—
Activated partial thromboplastin time prolonged	Investigations	—	—	—	—	—	—	—
International normalised ratio increased	Investigations	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—	—
Lymphocyte count decreased	Investigations	—	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Oral pain	Gastrointestinal disorders	—	—	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Hypercalcaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—	—	—
Hypomagnesaemia	Metabolism and nutrition disorders	—	—	—	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Pneumonia, Small intestinal obstruction, Urinary tract infection, Mental status changes, Acquired oesophageal web, Large intestinal obstruction, Breast cellulitis.

Data from ClinicalTrials.gov NCT03251378 adverse events section.

Sponsor's own description

An open-label, dose escalation and expansion clinical trial to evaluate the safety, tolerability, and PK of fruquintinib in patients with advanced solid tumors, metastatic colorectal cancer and metastatic breast cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Fruquintinib: a novel antivascular endothelial growth factor receptor tyrosine kinase inhibitor for the treatment of metastatic colorectal cancer.
Zhang Y, Zou JY, Wang Z, Wang Y. · · 2019 · cited 55× · PMID 31496821 · DOI 10.2147/cmar.s215533
Efficacy and safety of regorafenib and fruquintinib as third-line treatment for colorectal cancer: a narrative review.
Xu X, Yu Y, Liu M, Liang L, et al · · 2022 · cited 18× · PMID 35261903 · DOI 10.21037/tcr-20-3539
Standard of Care and Promising New Agents for the Treatment of Mesenchymal Triple-Negative Breast Cancer.
Mezi S, Botticelli A, Pomati G, Cerbelli B, et al · · 2021 · cited 14× · PMID 33802438 · DOI 10.3390/cancers13051080
Targeting RTKs/nRTKs as promising therapeutic strategies for the treatment of triple-negative breast cancer: evidence from clinical trials.
Mehta K, Hegde M, Girisa S, Vishwa R, et al · · 2024 · cited 9× · PMID 39668367 · DOI 10.1186/s40779-024-00582-z
Phase 1/1b open-label, dose-escalation study of fruquintinib in patients with advanced solid tumors in the United States.
Wang-Gillam A, Schelman W, Ukrainskyj S, Chien C, et al · · 2023 · cited 8× · PMID 37796398 · DOI 10.1007/s10637-023-01395-y
Population Pharmacokinetics of Fruquintinib, a Selective Oral Inhibitor of VEGFR -1, -2, and -3, in Patients with Refractory Metastatic Colorectal Cancer.
Zhou X, Yang X, Grinshpun B, Taylor A, et al · · 2025 · cited 5× · PMID 39969131 · DOI 10.1002/jcph.70001
Cytokine Networks in Triple-Negative Breast Cancer: Mechanisms, Therapeutic Targets, and Emerging Strategies.
Rosado-Sanz M, Martínez-Alarcón N, Abellán-Soriano A, Golfe R, et al · · 2025 · cited 2× · PMID 40868199 · DOI 10.3390/biomedicines13081945
Targeting tumor dormancy: the next frontier in gastrointestinal stromal tumor therapy.
Wu S, Liu H, Yin Y, Li J, et al · · 2026 · PMID 41955967 · DOI 10.1016/j.neo.2026.101306

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03251378 (US National Library of Medicine, public domain)
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 Hutchison Medipharma Limited
Last refreshed: 25 September 2024

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/NCT03251378.

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NCT03251378

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

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Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (49 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Advanced Solid Tumors

Other Hutchison Medipharma Limited trials

Verify against primary sources