An Extension Protocol for Subjects Who Were Previously Enrolled in Other ARQ 197 Protocols
- Conditions
- on-Small Cell Lung Cancer (NSCLC) Renal Cell carcinoma (RCC) Hepatocellular carcinoma(HCC)MedDRA version: 14.1Level: PTClassification code 10029522Term: Non-small cell lung cancer stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]MedDRA version: 14.1Level: PTClassification code 10029521Term: Non-small cell lung cancer stage IIIBSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10038407Term: Renal cell cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 14.1Level: LLTClassification code 10019828Term: Hepatocellular carcinoma non-resectableSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2010-020151-31-IT
- Lead Sponsor
- ARQULE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 60
1. Signed written informed consent to Study ARQ 197-299 2. Male or female subjects of the age defined in the original protocol they were enrolled. 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) =3 4. Adequate bone marrow function: - Absolute neutrophil count (ANC) =1.5 x 10 to the 9th/L - Hemoglobin =8.0 g/dL 5. Enrollment within 14 days of the completion of End of Study Visit of the original study 6. Subjects, 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 7. 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
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
1. Known or suspected allergy to ARQ 197 2. Substance abuse, medical, psychological or social conditions that may interfere with the subject’s participation in the study or evaluation of the study results 3. Any condition that is unstable or which could jeopardize the safety of the subject and his/her compliance in the study 4. A serious uncontrolled medical disorder/condition that in the opinion of the Investigator would impair the ability of the subject to receive protocol therapy 5. 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 subject does not have progressive disease - the radiation field does not encompass a target lesion - no more than 10% of the subject’s bone marrow is irradiated E.5 Primary end point(s): This open label extension protocol will provide subjects who participated in previous ARQ197 studies that have reached their designed end-dates and who may have benefited from the treatment with uninterrupted access to the study drug. Avere i requisiti per ricevere altre chemioterapie concorrenti (escluse terapie combinate definite nel protocollo d'origine), immunoterapia, radioterapia, o qualsiasi altro farmaco investigativo durante lo studio. La radioterapia palliativa è permessa, a condizione che: - secondo l'opinione del medico dello studio, il soggetto non abbia avuto una progressione di malattia il campo della radiazione non comprenda una lesione bersaglio non piùdel 10% del midollo osseo del soggetto sia irradiato
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this extension protocol is to provide subjects who participated in previous ARQ 197 studies that have reached their designated end-dates with uninterrupted access to ARQ 197 if, in the opinion of the Investigator and the Sponsor, they may benefit from the treatment.;Secondary Objective: The secondary objective of this study is to collect additional safety, tolerability and efficacy information for ARQ 197 treatment.;Primary end point(s): This open label extension protocol will provide subjects who participated in previous ARQ197 studies that have reached their designed end-dates and who may have benefited from the treatment with uninterrupted access to the study drug.;Timepoint(s) of evaluation of this end point: Because of the nature of this study, no formal statistical analysis is planned. Analyses on all baseline, efficacy and safety.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): NA;Timepoint(s) of evaluation of this end point: NA