Clinical trial NCT00612703: A Phase 1 Study of ARQ 197 in Adult Patients With Advanced Solid Tumors
Official title: A Phase 1 Dose Escalation Study of ARQ 197 Administered in Combination With Erlotinib in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer
Keywords: Cancer, oral, erlotinib, tarceva, solid tumor, advanced tumor, phase 1
Tumor
Lead sponsor: ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Sponsor class: INDUSTRY
First posted: 2008-02-12
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors


Eligibility criteria: Inclusion Criteria:

* Signed written informed consent must be obtained and documented according to International Conference on Harmonization (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior to study-specific screening procedures
* A histologically or cytologically confirmed solid tumor that is advanced, metastatic, and/or inoperable following prior standard chemotherapy, and/or for which, in the opinion of the investigator, there is no alternative therapy, or for which monotherapy with erlotinib is appropriate
* ≥ 18 years of age
* Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)

Exclusion Criteria:

* Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents within four weeks of first dose (patients currently on erlotinib monotherapy may be enrolled into the study without a washout)
* Major surgery within 4 weeks prior to first dose
* Central nervous system metastasis unless it has been stable for ≥ 3 months after treatment and patient has no neural symptoms
* Pregnant or breastfeeding
* Significant gastrointestinal disorder that, in the opinion of the Investigator, could interfere with the absorption of ARQ 197 and/or erlotinib (e.g. significant, uncontrolled inflammatory bowel disease or extensive small bowel resection)

Primary outcomes:
measure: To determine the safety, tolerability and recommended Phase 2 dose of ARQ 197 when administered in combination with erlotinib to patients with advanced solid tumors
timeFrame: No time frame
Secondary outcomes:
measure: To determine the pharmacokinetic profiles of ARQ 197 and erlotinib, when administered in combination to patients with advanced solid tumors
timeFrame: No time frame
measure: To assess the preliminary anti-tumor activity of ARQ 197 when administered in combination with erlotinib to adult patients with advanced solid tumors
timeFrame: No time frame
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: San Diego Pacific Oncology and Hematology Associates Inc.
state: California
city: Santa Monica
country: United States
facility: Premiere Oncology
state: California
Study officials:
affiliation: Premiere Oncology of Santa Monica
name: Lee Rosen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pacific Oncology and Hematology Associates
name: Richard G Just, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldman JW, Laux I, Chai F, Savage RE, Ferrari D, Garmey EG, Just RG, Rosen LS. Phase 1 dose-escalation trial evaluating the combination of the selective MET (mesenchymal-epithelial transition factor) inhibitor tivantinib (ARQ 197) plus erlotinib. Cancer. 2012 Dec 1;118(23):5903-11. doi: 10.1002/cncr.27575. Epub 2012 May 17.