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| Name | Class |
|---|---|
| Novartis Pharmaceuticals | INDUSTRY |
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The investigators propose this Phase I trial of the combination of AUY922 and capecitabine to determine the maximum tolerated dose (MTD) in patients with advanced solid tumors. This combination treatment has potential applicability in tumor types where capecitabine or fluorouracil is a treatment option, including colorectal and breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Level 1 | Experimental | Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles |
|
| Dose Level 2 | Experimental | Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles |
|
| Dose Level 3 | Experimental | Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles |
|
| Dose Level 4 | Experimental | Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles |
|
| Dose Level 5 | Experimental | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capecitabine | Drug | Taken orally twice daily on Days 1 through 14 of 21 day cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose Determination | To determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors. | 18 months |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Related Toxicities | To evaluate the drug related toxicities associated with different doses of the drugs used in this regimen. | 18 months |
| Preliminary Efficacy Assessment: Response Rate (RR) |
Not provided
Inclusion Criteria:
Histologically confirmed metastatic or unresectable solid tumor malignancy that is incurable and for which capecitabine is clinically appropriate.
Patient must be ≥4 weeks from administration of last dose of cancer therapy (including radiation therapy, biologic therapy, hormonal therapy or chemotherapy). Patients who received a small molecule targeted therapy as part of their first line treatment regimen must be ≥4 weeks or ≥5 half lives from administration of last dose whichever is shorter. The patient must have recovered from or come to a new chronic stable baseline from all treatment-related toxicities.
Eastern Collaborative Oncology Group (ECOG) performance status 0 to 1 (see Appendix A).
Life expectancy of ≥3 months.
At least one unidimensional measurable lesion definable by MRI or CT scan. Disease must be measurable per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria (see Section 9).
Normal bone marrow function defined as:
Adequate hepatic function defined as:
Renal function defined as:
• Serum creatinine ≤1.5 x ULN or 24-hour creatinine clearance ≥40 mL/min
Normal electrolytes defined as:
Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test performed within 7 days prior to start of treatment. Women of childbearing potential must use effective birth control measures during treatment and during the 6 months following completion of study treatment. If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.
Must be ≥18 years of age.
Patients must be accessible for treatment and follow-up.
Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.
Exclusion Criteria:
Untreated CNS metastases. Patients with treated CNS metastases may be enrolled, provided the patient is asymptomatic, and the patient does not require antiepileptic drugs or steroids as treatment for the CNS metastases.
Treatment with therapeutic doses of coumarin-type anticoagulants (maximum daily dose of 1 mg allowed for port line patency permitted).
Impaired cardiac function with any one of the following:
Impairment of gastrointestinal function or gastrointestinal disease that in the opinion of the Investigator may significantly alter the absorption of study drugs (e.g., Crohn's disease, ulcerative disease, uncontrolled vomiting, diarrhea, or malabsorption syndrome).
Patients with known diagnosis of human immunodeficiency virus (HIV), hepatitis C virus, or acute or chronic hepatitis B infection.
Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness/social situations that would limit compliance with study requirements.
Women who are pregnant (positive pregnancy test) or lactating.
Any condition that would prevent patient comprehension of the nature of, and risk associated with, the study, and the inability to comply with study and/or follow-up procedures.
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| Name | Affiliation | Role |
|---|---|---|
| Johanna C Bendell, MD | SCRI Development Innovations, LLC | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Cancer Specialists | Fort Myers | Florida | 33916 | United States | ||
| Oklahoma University |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dose Level 1 | Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Dose Level 6 | Experimental | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles |
|
|
| Hsp90 Inhibitor AUY 922 | Drug | IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
|
Response Rate (RR) is defined as the total number of patients with Complete Response (CR) or Partial Response (PR) as defined in RECIST v2. CR is defined as the dissappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor markers. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
| 18 months |
| Oklahoma City |
| Oklahoma |
| 71304 |
| United States |
| Tennessee Oncology | Nashville | Tennessee | 37203 | United States |
| Dose Level 2 |
Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| FG002 | Dose Level 3 | Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| FG003 | Dose Level 4 | Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| FG004 | Dose Level 5 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| FG005 | Dose Level 6 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dose Level 1 | Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| BG001 | Dose Level 2 | Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| BG002 | Dose Level 3 | Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| BG003 | Dose Level 4 | Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| BG004 | Dose Level 5 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| BG005 | Dose Level 6 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Dose Determination | To determine the maximum tolerated dose (MTD) of AUY922 plus capecitabine in patients with advanced solid tumors. | Posted | Number | mg/m^2 | 18 months |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Drug Related Toxicities | To evaluate the drug related toxicities associated with different doses of the drugs used in this regimen. | Posted | Number | participants | 18 months |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Preliminary Efficacy Assessment: Response Rate (RR) | Response Rate (RR) is defined as the total number of patients with Complete Response (CR) or Partial Response (PR) as defined in RECIST v2. CR is defined as the dissappearance of all target lesions, disappearance of all non-target lesions and normalization of tumor markers. PR is defined as at least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD. | Includes all patients evaluable for response. 4 patients were not evaluable: dose level 2 (1 pt), dose level 4 (2 pts), dose level 6 (1 pt). | Posted | Number | participants | 18 months |
|
18 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Dose Level 1 | Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle | 1 | 3 | 3 | 3 | ||
| EG001 | Dose Level 2 | Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle | 0 | 3 | 3 | 3 | ||
| EG002 | Dose Level 3 | Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle | 0 | 3 | 3 | 3 | ||
| EG003 | Dose Level 4 | Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle | 1 | 5 | 5 | 5 | ||
| EG004 | Dose Level 5 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle | 0 | 3 | 3 | 3 | ||
| EG005 | Dose Level 6 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle | 0 | 6 | 6 | 6 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General disorders and administration site conditions - Other, failure to thrive | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye disorders - Other, vision changes | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Mucositis | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Edema limbs | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Floaters | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Weight loss | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry eye | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Flashing lights | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hyperuricemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin and subcutaneous tissue disorders - Other, skin changes | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | CTCAE (4.0) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Eye disorders - Other, color differentiation difficulties | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
|
The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John D Hainsworth, MD | Sarah Cannon Research Institute | 1-877-691-7274 | asksarah@scresearch.net |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069287 | Capecitabine |
| ID | Term |
|---|---|
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
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| Male |
|
| Dose Level 4 |
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| OG004 | Dose Level 5 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
| OG005 | Dose Level 6 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle. Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle |
|
|
| OG003 |
| Dose Level 4 |
Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles |
| OG004 | Dose Level 5 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles |
| OG005 | Dose Level 6 | Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles |
|
|