TriangleNCT01178411 · REGISTRY CONDITION SEARCH
An Extension Protocol for Subjects Who Were Previously Enrolled in Other Tivantinib (ARQ 197) Protocols
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE1, PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2021-03-10
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Extent of Exposure to ARQ 197 in Participants Benefiting From Prior ARQ 197 Therapy
Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
Number of Participants Discontinuing Treatment Due to an AE
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: * Signed written informed consent to participate in clinical study of tivantinib * Male or female participants of the age defined in the original protocol they were enrolled. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤3 (or ≤2 for tivantinib-naive participants) * Adequate bone marrow function: * Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L * Hemoglobin ≥8.0 g/dL (or ≥ 9.0 g/dL for tivantinib-naïve participants) * Enrollment within 14 days of the completion of End of Treatment Visit of the original study * Participants, who participated in previous ARQ 197 studies that have reached their designated end-dates, who did not meet discontinuation criteria in their original study, and who may, in the opinion of the Investigator and the Sponsor, benefit from treatment * Women of childbearing potential must have a negative pregnancy test performed within 14 days of the start of study drug. Both men and women enrolled in this study must agree to use adequate birth control measures while on study Exclusion Criteria: * Known or suspected allergy to ARQ 197 * Substance abuse, medical, psychological or social conditions that may interfere with the participant's participation in the study or evaluation of the study results * Any condition that is unstable or which could jeopardize the safety of the participant and his/her compliance in the study * A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the participant to receive protocol therapy * Requirement to receive other concurrent chemotherapy (excluding combination therapy defined in original protocol), immunotherapy, radiotherapy, or any other investigational drug while on study. Palliative radiotherapy is allowed provided that: * in the opinion of the Investigator, the participant does not have progressive disease * the radiation field does not encompass a target lesion * no more than 10% of the participant's bone marrow is irradiated
- healthy Volunteers
- false
- minimum Age
- 13 Years
- sex
- ALL
- std Ages
- CHILD
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Tivantinib 360 mg will be administered twice daily, orally, with meals, as a monotherapy or in combination with other drug therapies.
- intervention Names
- Drug: Tivantinib
- Drug: Anti-Cancer Combination Therapy
- label
- Tivantinib (Monotherapy or Combination Therapy)
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Tivantinib (Monotherapy or Combination Therapy)
- description
- Tivantinib 360 mg (3 x 120 mg tablets or capsules) twice daily by mouth.
- name
- Tivantinib
- other Names
- ARQ 197
- type
- DRUG
- arm Group Labels
- Tivantinib (Monotherapy or Combination Therapy)
- description
- Tivantinib 360 mg twice daily in combination with other anti-cancer therapy (eg, erlotinib,sorafenib, pemetrexed, docataxel, gemcitabine, irinotecan, and/or cetuximab) at the same dose and schedule in which they were administered in the original (previous) study.
- name
- Anti-Cancer Combination Therapy
- other Names
- ARQ 197
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 60
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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).
- measure
- Extent of Exposure to ARQ 197 in Participants Benefiting From Prior ARQ 197 Therapy
- time Frame
- Up to 3,021 days (up to 14-Jan-2019)
- secondary Outcomes
- description
- 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.
- measure
- Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)
- time Frame
- Up to 3021 days
- description
- 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.
- measure
- Number of Participants Discontinuing Treatment Due to an AE
- time Frame
- Up to 3,021 days
Full study description
- brief Summary
- 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.
- detailed Description
- This open label extension protocol enrolls participants who were treated in previous phase 1 (NCT01149720, NCT01517399, NCT01699061, NCT00612703, NCT00827177, and NCT00874042) and phase 2 (NCT00777309, NCT00557609, NCT00988741, NCT01395758 , and NCT01055067) tivantinib studies that have reached their designated end-dates. Participants enrolled in this extension protocol will provide further safety and tolerability information about tivantinib monotherapy or in combination with other drug(s) at the same dose(s), and same schedule(s) in which they were originally enrolled.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-832faaba7c80d8c70957
- requested nct id
- NCT01178411
- primary nct id
- NCT01178411
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- 359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
- payload sha256
- bf9a8366fc7ba673b1911c2910ac17c9656ef402bdc93b0eb8586a392fa65e61
- payload
- clinical indication matching status
- condition_index_match_asserted_by_registry_not_reviewed
- end exclusive
- true
- id
- nct-edge-832faaba7c80d8c70957
- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT01178411
- occurrences
- context exact
- NCT01178411
- end
- 11
- exact text
- NCT01178411
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Ovarian Germ Cell Tumors
- query disease state id
- ds-ovarian-germ-cell-tumors
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-ovarian-germ-cell-tumors-000.json
- source file sha256
- 359ee71d54598877a70c4f96300e96532a9c096cf831e27a29687916b1e2237d
- source json pointer
- /studies/6/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- e0145f68b10109043c35d1bf5f64873dac5d72f0ebeb74e2d642fb7cc618ba56
Preserved source evidence · Not medical advice