Open-label Phase 1b Study of ARQ 092 in Combination With Carboplatin Plus Paclitaxel
Information source: ArQule
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Breast Cancer Triple Negative
Intervention: ARQ 092 + carboplatin + paclitaxel (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: ArQule Overall contact: ArQule, Inc., Phone: 781-994-0300, Email: ClinicalTrials@arqule.com
Summary
An Open-label Phase 1b Study of ARQ 092 in Combination with Carboplatin Plus Paclitaxel in
Subjects with Selected Solid Tumors
Clinical Details
Official title: An Open-label Phase 1b Study of ARQ 092 in Combination With Carboplatin Plus Paclitaxel in Subjects With Selected Solid Tumors
Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Adverse events graded by CTCAE v4.03 as a measure of the safety and tolerability profile of ARQ 092 administered in combination with carboplatin and paclitaxel
Secondary outcome: Characterize the pharmacokinetic (PK) profile of ARQ 092 when administered in combination with carboplatin and paclitaxelEvaluate tumor response assessed by RECIST v1.1 after treatment with ARQ 092 administered in combination with carboplatin and paclitaxel Evaluate dose limiting toxicity (DLT) graded per CTCAE v4.03 to determine the recommended Phase 2 dosing regimen
Detailed description:
This is an open-label, Phase 1b, dose escalation study of oral ARQ 092 administered in
combination with carboplatin and paclitaxel in subjects with advanced, inoperable metastatic
and/or recurrent solid tumors.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. Signed written informed consent form
2. 18 years of age or older
3. Histologically or cytologically confirmed locally advanced, inoperable, or metastatic
tumors
4. Female subjects of child-bearing potential must have a negative serum or urine
pregnancy test within 72 hours prior to the first dose of study drug
5. Measurable disease
6. Subjects must agree to provide archival and/or fresh tissue biopsy samples, if
available
7. ECOG performance status ≤ 2
8. Life expectancy ≥ 12 weeks
9. Failure to respond to standard therapy, or for whom standard therapy does not exist,
or is not tolerable
10. Absolute neutrophil count (ANC) ≥ 1. 5 x 109/L Platelet count (Plt) ≥ 100 x 109/L
Hemoglobin (Hb) ≥ 9 g/dL Serum creatinine ≤ 1. 5 x upper limit of normal (ULN) or
Calculated creatinine clearance ≥ 60 mL/min /1. 73 m2 for subjects with serum
creatinine levels > 1. 5 x institutional ULN Total bilirubin ≤ 1. 5 x ULN or Direct
bilirubin ≤ ULN for subjects with total bilirubin levels > 1. 5 x ULN AST and ALT ≤ 3
x ULN or ≤ 5 x ULN for subjects with known liver metastases HbA1c ≤ 8%
11. If a subject is currently receiving bisphosphonates, the subject must have received
the bisphosphonates for at least four weeks before starting study treatment
12. Male or female subjects of child-bearing potential must agree to use double-barrier
contraceptive measures, oral contraception, or avoidance of intercourse during and
after the study
Exclusion Criteria:
1. Anti-cancer therapy within four weeks prior to administration of the first dose of
study drug
2. Radiation therapy within four weeks prior to administration of the first dose of
study drug
3. Major surgical procedure within four weeks prior to administration of the first dose
of study drug
4. Previous treatment with AKT inhibitors
5. Contraindications to treatment with carboplatin and/or paclitaxel defined by the
Investigator based on the FDA approved labeling or institutional SOC
6. History of allergic reaction attributed to compound(s) of similar chemical or
biologic composition as ARQ 092 or carboplatin and/or paclitaxel
7. Unable or unwilling to swallow ARQ 092 or comply with chemotherapy regimen
8. Known active CNS metastases and/or carcinomatous meningitis
9. History of myocardial infarction (MI) or congestive heart failure defined as Class II
to IV per the NYHA classification within 6 months of the first dose of ARQ 092
10. History of Type 1 or 2 diabetes mellitus requiring regular medication (other than
oral hypoglycemic agents including metformin) or fasting glucose ≥ 160 mg/dL
11. Significant gastrointestinal disorder(s), that could in the opinion of the
Investigator, interfere with the absorption, metabolism, or excretion of ARQ 092
12. Previous malignancy within 2 years of the first dose of study drugs, except
curatively treated non-melanoma skin cancer, carcinoma in-situ of the breast or
cervix, superficial bladder tumors
13. Concurrent uncontrolled illness not related to cancer, including but not limited to
ongoing or active infection, including HIV, HBV (HbsAg positive; subjects with
documented laboratory evidence of HBV clearance may be enrolled) or HCV (positive HCV
antibody), or bleeding
14. Psychiatric illness, substance abuse, and/or social situation that would limit
compliance with study requirements
15. Blood transfusion within 5 days of the blood draw being used to confirm eligibility
16. Pregnant or breastfeeding
Locations and Contacts
ArQule, Inc., Phone: 781-994-0300, Email: ClinicalTrials@arqule.com
San Antonio, Texas 78229, United States; Recruiting
Additional Information
Starting date: June 2015
Last updated: June 17, 2015
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