NCT01702558 (TRAXHER2) is a Phase 2 clinical trial of Capecitabine in Breast Cancer, sponsored by Hoffmann-La Roche.

Who is sponsoring NCT01702558?

NCT01702558 is sponsored by Hoffmann-La Roche.

What drugs are being tested in NCT01702558?

Interventions in NCT01702558: Capecitabine, Trastuzumab emtansine (T-DM1), Trastuzumab emtansine (T-DM1), Capecitabine.

What condition does NCT01702558 study?

NCT01702558 studies Breast Cancer, Gastric Cancer.

Is NCT01702558 still recruiting?

NCT01702558 is currently terminated. Last updated 22 January 2021.

Are results published for NCT01702558?

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

Last reviewed 2021-01-22 · How we verify

NCT01702558: TRAXHER2

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

A Combination Study of Kadcyla (Trastuzumab Emtansine) and Capecitabine in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer (mBC) or HER2-Positive Locally Advanced/Metastatic Gastric Cancer (LA/mGC)

Terminated Phase 2 Results posted Last updated 22 January 2021

What this trial tests

Phase 2 trial testing Capecitabine in Breast Cancer in 182 participants. Terminated before completion.

Timeline

3 December 2012

Primary endpoint
31 May 2017

31 May 2017

Quick facts

Lead sponsor	Hoffmann-La Roche
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	182
Start date	3 December 2012
Primary completion	31 May 2017
Estimated completion	31 May 2017
Sites	40 locations across France, Italy, Slovakia, Russia, Greece, Serbia, Germany, Argentina

Drugs / interventions tested

Capecitabine (capecitabine) — full drug profile →
Trastuzumab emtansine (T-DM1) (trastuzumab-emtansine-t-dm1) — full drug profile →
Trastuzumab emtansine (T-DM1) (trastuzumab-emtansine-t-dm1) — full drug profile →
Capecitabine (capecitabine) — full drug profile →

Conditions studied

Breast Cancer — all drugs for Breast Cancer →
Gastric Cancer — all drugs for Gastric Cancer →

Sponsor

Hoffmann-La Roche — full company profile →

Who can join

18 and older, any sex, with Breast Cancer or Gastric 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.

Phase 1 (mBC): Percentage of Participants With Dose-Limiting Toxicities (DLTs) Primary · Continuously during Cycle 1 (up to 3 weeks)

A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting more than (\>) 7 consecutive days; febrile neutropenia with absolute neutrophil count (ANC) less than (\<) 1000 cells/millimeter cube (mm\^3); Grade greater than or equal to (\>/=) 3 diarrhea or Grade 3 hand-foot syndrome (in absence of dihydropyrimidine dehydrogenase \[DPD\] deficiency only for DL 1); any other Gr

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	33.3
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	0.0

Phase 1 (mBC): Maximum Tolerated Dose (MTD) of Capecitabine When Combined With Trastuzumab Emtansine (3.6 mg/kg Every 3 Weeks) Primary · Continuously during Cycle 1 (up to 3 weeks)

MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting \>7 consecutive days; febrile neutropenia with ANC \<1000 cells/mm\^3; Grade \>/=3 diarrhea or Grade 3 hand-foot syndrome (in absence of DPD deficiency only for DL 1); any other Grade \>/=3 toxici

Group	Value	95% CI
Phase 1 (mBC) Cohort 1: T-DM1 + Cape	700

Phase 2 (mBC): Percentage of Participants With Best Overall Response (BOR) as Assessed by the Investigator According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Primary · Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 2.5 years overall)

Tumor response was assessed by the investigator according to RECIST v1.1. BOR was defined as percentage of participants with a complete response (CR) or partial response (PR) that was confirmed by repeat assessments \>/=4 weeks after initial documentation. CR was defined as the disappearance of all target lesions (TLs) and non-TLs; short axis (SA) reduction to \<10 millimeters (mm) for nodal TLs/non-TLs; and no new lesions. PR was defined as \>/=30% decrease in sum of diameters (SoD) of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions. The 90% confidence

Group	Value	95% CI
Phase 2 (mBC): T-DM1 + Cape	44.4	35.0 – 54.2
Phase 2 (mBC): T-DM1	36.3	27.3 – 46.0

Phase 1 (LA/mGC): Percentage of Participants With DLTs Primary · Continuously during 3 weeks

A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting \>7 consecutive days; febrile neutropenia with ANC \<1000 cells/mm\^3; Grade \>/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade \>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxicity requiring treatment interruption for \>14 days; \<14 full doses of capecitabine; Cycle 2 dose level \<100%.

Group	Value	95% CI
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape	0.0

Phase 1 (LA/mGC): MTD of Capecitabine When Combined With Trastuzumab Emtansine (2.4 mg/kg QW) Primary · Continuously during 3 weeks

MTD was defined as the dose level for which the probability of DLT is equal to a protocol-specified target probability. A DLT was defined as any one of the following study treatment related toxicities: Uncomplicated Grade 4 thrombocytopenia that does not recover before Day 21; thrombocytopenia complicated with clinically significant bleeding requiring medical intervention; Grade 4 neutropenia lasting \>7 consecutive days; febrile neutropenia with ANC \<1000 cells/mm\^3; Grade \>/=3 diarrhea or Grade 3 hand-foot syndrome; any other Grade \>/=3 toxicity prohibiting start of Cycle 2; Grade 2 toxi

Group	Value	95% CI
Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape	700

Phase 1 (mBC): Percentage of Participants With BOR as Assessed by the Investigator According to RECIST v1.1 Secondary · Baseline until CR/PR, consent withdrawal, or study end whichever occurred first (up to approximately 3.5 years overall)

Tumor response was assessed by the investigator according to RECIST v1.1. BOR in Phase 1 was defined as percentage of participants with a CR or PR. CR was defined as the disappearance of all TLs and non-TLs; SA reduction to \<10 mm for nodal TLs/non-TLs; and no new lesions. PR was defined as \>/=30% decrease in SoD of TLs, taking as reference the baseline SoD; no progression in non-TLs; and no new lesions.

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	83.3
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	100.0

Phase 1 (mBC): Serum Concentration of Trastuzumab Emtansine Secondary · Pre-trastuzumab emtansine dose (0 hour [h]) on Day 1 Cycle 2; 15-30 minutes (min) after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)

Cycle 1, Post-dose

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	81.3	± 13.3
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	78.6	± 14.6

Cycle 2, Pre-dose

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	1.17	± 1.25
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	2.1	± 1.49

Cycle 2, Post-dose

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	70.5	± 13.3
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	78.5	± 14.9

Phase 1 (mBC): Serum Concentration of Trastuzumab Secondary · Pre-trastuzumab emtansine dose (0 h) on Day 1 Cycle 2; 15-30 min after end of trastuzumab emtansine infusion (maximum infusion duration = 90 min) on Day 2 Cycle 1 and Day 1 Cycle 2 (cycle length=21 days)

Trastuzumab was derived from trastuzumab emtansine.

Cycle 1, Post-dose

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	89.1	± 24.37
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	92.9	± 22.13

Cycle 2, Pre-dose

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	11.8	± 13.28
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	14.0	± 12.53

Cycle 2, Post-dose

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	74.8	± 18.89
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	94.7	± 24.60

Phase 1 (mBC): Maximum Observed Plasma Concentration (Cmax) of Capecitabine Secondary · Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1

Cmax for Capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for percent coefficient of variation (CV%) and not for standard deviation.

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	2990	± 38.4
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	5652	± 91.1

Phase 1 (mBC): Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC[0-inf]) of Capecitabine Secondary · Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1

AUC(0-inf) is the measure of total drug exposure and is dependent on the total amount of drug absorbed. AUC(0-inf) for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	3973	± 38.0
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	5440	± 57.7

Phase 1 (mBC): Plasma Terminal Half-Life (t1/2) of Capecitabine Secondary · Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1

Plasma terminal half-life is the time measured for the plasma drug concentration to decrease by one half during the elimination phase of the drug. t1/2 for capecitabine was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	0.70	± 131.9
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	0.39	± 38.8

Phase 1 (mBC): Cmax of 5-Fluorouracil (Metabolite of Capecitabine) Secondary · Pre-capecitabine dose (0 h) and 0.5, 1, 1.5, 2, 2.5, 4, and 6 h post-capecitabine dose on Day 1 Cycle 1

5-fluorouracil is a metabolite of capecitabine. Cmax for 5-fluorouracil was estimated from plasma concentration versus time data using non-compartmental methods of analysis. Reported dispersion values are for CV% and not for standard deviation.

Group	Value	95% CI
Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape	148	± 49.9
Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape	143	± 45.6

Adverse events — posted to ClinicalTrials.gov

Time frame: Phase 1: Baseline up to 42 days after last dose (up to approximately 1.5 years overall); Phase 2: Baseline up to 42 days after last dose (up to approximately 2.5 years overall). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Phase 1 (mBC) Cohort 1 (DL 1): T-DM1 + Cape

Serious: 0/7 (0%)

Deaths: 4/7

Phase 1 (mBC) Cohort 1 (DL -1): T-DM1 + Cape

Serious: 2/5 (40%)

Deaths: 3/5

Phase 1 (LA/mGC) Cohort 2 (DL -1): T-DM1 + Cape

Serious: 4/6 (67%)

Deaths: 3/6

Phase 2 (mBC): T-DM1 + Cape

Serious: 11/82 (13%)

Deaths: 18/82

Phase 2 (mBC): T-DM1

Serious: 10/78 (13%)

Deaths: 21/78

Serious adverse events (36 terms)

Reaction	System	Phase 1 (mBC) Cohort 1 (DL…	Phase 1 (mBC) Cohort 1 (DL…	Phase 1 (LA/mGC) Cohort 2 …	Phase 2 (mBC): T-DM1 + Cape	Phase 2 (mBC): T-DM1
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Muscular weakness	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pathological fracture	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Brain oedema	Nervous system disorders	—	—	—	—	—
Cerebral cyst	Nervous system disorders	—	—	—	—	—
Radiation necrosis	Injury, poisoning and procedural complications	—	—	—	—	—
Myocardial infarction	Cardiac disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Device related sepsis	Infections and infestations	—	—	—	—	—
Tumour haemorrhage	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—
Renal colic	Renal and urinary disorders	—	—	—	—	—
Tumour excision	Surgical and medical procedures	—	—	—	—	—
Colitis ischaemic	Gastrointestinal disorders	—	—	—	—	—
Intestinal haematoma	Gastrointestinal disorders	—	—	—	—	—
Mesenteric vein thrombosis	Gastrointestinal disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—	—
Bacterial sepsis	Infections and infestations	—	—	—	—	—
Device related infection	Infections and infestations	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—	—
Wound sepsis	Infections and infestations	—	—	—	—	—
Haematuria	Renal and urinary disorders	—	—	—	—	—
Anuria	Renal and urinary disorders	—	—	—	—	—
Pleural effusion	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—

Other adverse events (231 terms — click to expand)

Reaction	System	Phase 1 (mBC) Cohort 1 (DL…	Phase 1 (mBC) Cohort 1 (DL…	Phase 1 (LA/mGC) Cohort 2 …	Phase 2 (mBC): T-DM1 + Cape	Phase 2 (mBC): T-DM1
Thrombocytopenia	Blood and lymphatic system disorders	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—
Asthenia	General disorders	—	—	—	—	—
Palmar-plantar erythrodysaesthesia syndrome	Skin and subcutaneous tissue disorders	—	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—	—
Gamma-glutamyltransferase increased	Investigations	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Blood alkaline phosphatase increased	Investigations	—	—	—	—	—
Platelet count decreased	Investigations	—	—	—	—	—
Neutropenia	Blood and lymphatic system disorders	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—
Dry mouth	Gastrointestinal disorders	—	—	—	—	—
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—
Lacrimation increased	Eye disorders	—	—	—	—	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Chills	General disorders	—	—	—	—	—
Paraesthesia	Nervous system disorders	—	—	—	—	—
Alopecia	Skin and subcutaneous tissue disorders	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—	—
Hyperglycaemia	Metabolism and nutrition disorders	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—
Oedema peripheral	General disorders	—	—	—	—	—

Most-reported serious reactions: Abdominal pain, Muscular weakness, Pathological fracture, Brain oedema, Cerebral cyst, Radiation necrosis, Myocardial infarction, Diarrhoea.

Data from ClinicalTrials.gov NCT01702558 adverse events section.

Sponsor's own description

This multicenter study will assess the maximum tolerated dose (MTD) of capecitabine in combination with Kadcyla (trastuzumab emtansine) in participants with HER2-positive mBC or HER2-positive LA/mGC using a Phase 1 design, followed by a randomized, open-label Phase 2 part to explore the efficacy and safety of the combination of Kadcyla and capecitabine compared with Kadcyla alone in participants with mBC. The anticipated time on study treatment is until disease progression, intolerable toxicity, withdrawal of consent, or study end.

Publications & conference data

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

Trastuzumab emtansine: mechanisms of action and drug resistance.
Barok M, Joensuu H, Isola J. · · 2014 · cited 406× · PMID 24887180 · DOI 10.1186/bcr3621
The promise and challenges of combination therapies with antibody-drug conjugates in solid tumors.
Wei Q, Li P, Yang T, Zhu J, et al · · 2024 · cited 102× · PMID 38178200 · DOI 10.1186/s13045-023-01509-2
Perspectives of HER2-targeting in gastric and esophageal cancer.
Gerson JN, Skariah S, Denlinger CS, Astsaturov I. · · 2017 · cited 68× · PMID 28387541 · DOI 10.1080/13543784.2017.1315406
Trastuzumab emtansine: the first targeted chemotherapy for treatment of breast cancer.
Peddi PF, Hurvitz SA. · · 2013 · cited 50× · PMID 23469968 · DOI 10.2217/fon.13.7
Beyond the Paclitaxel and Vinca Alkaloids: Next Generation of Plant-Derived Microtubule-Targeting Agents with Potential Anticancer Activity.
Zhang D, Kanakkanthara A. · · 2020 · cited 48× · PMID 32610496 · DOI 10.3390/cancers12071721
Efficacy and Safety of Trastuzumab Emtansine Plus Capecitabine vs Trastuzumab Emtansine Alone in Patients With Previously Treated ERBB2 (HER2)-Positive Metastatic Breast Cancer: A Phase 1 and Randomized Phase 2 Trial.
Cortés J, Diéras V, Lorenzen S, Montemurro F, et al · · 2020 · cited 37× · PMID 32584367 · DOI 10.1001/jamaoncol.2020.1796
Role of trastuzumab emtansine in the treatment of HER2-positive breast cancer.
Oostra DR, Macrae ER. · · 2014 · cited 37× · PMID 25114588 · DOI 10.2147/bctt.s67297
Personalized medicine in gastric cancer: Where are we and where are we going?
Jácome AA, Coutinho AK, Lima EM, Andrade AC, et al · · 2016 · cited 36× · PMID 26811654 · DOI 10.3748/wjg.v22.i3.1160

Verify or expand the search:

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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 NCT01702558 (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 Hoffmann-La Roche
Last refreshed: 22 January 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/NCT01702558.

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