13 and older, any sex, with Advanced Solid Tumors. 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.
Extent of Exposure to ARQ 197 in Participants Benefiting From Prior ARQ 197 TherapyPrimary· Up to 3,021 days (up to 14-Jan-2019)
The duration of ARQ 197 exposure in this study was calculated as \[(date of last dose of study drug - date of first dose of study drug) + 1\]. Results refer to duration of ARQ 197 treatment in the present study only (i.e., does not include treatment received during participation in "feeder" studies).
Group
Value
95% CI
Tivantinib (Monotherapy or Combination)
125
5 – 3021
Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)Secondary· Up to 3021 days
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Group
Value
95% CI
Tivantinib (Monotherapy or Combination)
56
Number of Participants Discontinuing Treatment Due to an AESecondary· Up to 3,021 days
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Group
Value
95% CI
Tivantinib (Monotherapy or Combination)
6
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to 3021 days.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Tivantinib (Monotherapy or Combination)
Serious: 19/60 (32%)
Deaths: 4/60
Serious adverse events (35 terms)
Reaction
System
Tivantinib (Monotherapy or…
Disease progression
General disorders
—
Anaemia
Blood and lymphatic system disorders
—
Febrile neutropenia
Blood and lymphatic system disorders
—
Atrial fibrillation
Cardiac disorders
—
Cardiopulmonary failure
Cardiac disorders
—
Abdominal mass
Gastrointestinal disorders
—
Abdominal pain
Gastrointestinal disorders
—
Diarrhoea
Gastrointestinal disorders
—
Duodenal ulcer
Gastrointestinal disorders
—
Nausea
Gastrointestinal disorders
—
Small intestinal obstruction
Gastrointestinal disorders
—
Vomiting
Gastrointestinal disorders
—
Jaundice cholestatic
Hepatobiliary disorders
—
Bronchitis
Infections and infestations
—
Gastroenteritis
Infections and infestations
—
Influenza
Infections and infestations
—
Pneumonia
Infections and infestations
—
Sepsis
Infections and infestations
—
Urinary tract infection
Infections and infestations
—
Fractured Sacrum
Injury, poisoning and procedural complications
—
Decreased appetite
Metabolism and nutrition disorders
—
Dehydration
Metabolism and nutrition disorders
—
Pathological fracture
Musculoskeletal and connective tissue disorders
—
Metastases to central nervous system
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
This is an extension study that will allow participants to continue to receive study therapy when the original studies into which they were enrolled have reached their designated end-dates. This extension study is designed to further evaluate the safety and tolerability of tivantinib (ARQ 197) monotherapy or in combination with other drug(s) when given to participants who tolerated previous treatment well and may benefit from the continuing treatment.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
NCT01755767 — Study of Tivantinib in Subjects With Inoperable Hepatocellular Carcinoma (HCC) Who Have Been Treated With One Prior Ther
· Phase 3
· completed
NCT01749384 — Tivantinib and Bevacizumab in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery
· Phase 1
· completed
NCT01688973 — Tivantinib With or Without Erlotinib Hydrochloride in Treating Patients With Metastatic or Locally Advanced Kidney Cance
· Phase 2
· completed
NCT01696955 — Cetuximab With or Without Tivantinib in Treating Patients With Head and Neck Cancer That Is Recurrent, Metastatic, or Ca
· Phase 2
· completed
NCT01654965 — Tivantinib and Topotecan Hydrochloride in Treating Patients With Advanced or Metastatic Solid Tumors
· Phase 1
· completed
Other recruiting trials for Advanced Solid Tumors
Currently open trials in the same condition.
NCT07504445 — Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors
· EARLY_PHASE1
· recruiting
NCT07589530 — Phase 1/2 Study of EB-NK-301 (Allogeneic TROP2-CAR NK Cells) in Advanced TROP2-Expressing Solid Tumors
· Phase 1, PHASE2
· recruiting
NCT07414316 — A Single-Arm, Open-Label Clinical Study GK01 Cell Injection in Subjects With Advanced Solid Tumors.
· EARLY_PHASE1
· recruiting
NCT07222969 — A Clinical Study to Evaluate the Safety of VIB305 in Patients With Advanced Solid Tumors
· Phase 1, PHASE2
· recruiting
Other ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA) trials
Trials by the same sponsor.
NCT03162536 — A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-
· Phase 1, PHASE2
· active not recruiting
NCT03094832 — Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK
· Phase 1, PHASE2
· terminated
NCT02761694 — Vevorisertib (ARQ 751) as a Single Agent or in Combination With Other Anti-Cancer Agents, in Solid Tumors With PIK3CA /
· Phase 1
· terminated
NCT02762721 — Analysis of Oncogenes in Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma in Tumor Tissue Samp
· completed
NCT02476955 — Open-label Phase 1b Study of ARQ 092 in Combination With Anastrozole
· Phase 1
· terminated
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 ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Last refreshed: 10 March 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/NCT01178411.