Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01049 | Registry Identifier | NCI CTRP |
Not provided
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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Objectives:
Primary Objectives:
Phase I: Determine the maximal tolerated dose (MTD) of MK-0646 in combination with gemcitabine or gemcitabine plus erlotinib and recommended phase II dose.
Phase II:
Secondary Objectives:
Phase I
The Study Drugs:
MK-0646 is designed to block proteins that are thought to cause cancer cells to grow and spread. This drug may help slow the growth of tumors.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control the growth and survival of cancer cells. This may stop cancer cells from growing.
Study Drug Dose Level and Groups:
If you are found to be eligible to take part in this study, you will be assigned to a group (Arm A or Arm B) based on when you joined the study, how many participants have been enrolled before you, and on the safety data that is available at that time.
There are 2 dose levels of MK-0646 in each arm. There will be 3-6 participants enrolled in each dose level in each arm. Enrollment will begin in Arm A. Arm B will use the same 2 dose levels as Arm A. If the first dose level of Arm A is found to be tolerable, at least 3 patients will be enrolled in Arm B, Level 1, and then at least 3 patients will be enrolled in Arm A, Level 2. If Arm B, Level 1 and Arm A, Level 2 can be safely given, the last group of 3-6 patients will be enrolled in Arm B, Level 2. The first group of participants in each arm will receive the lower dose level. The next group in each arm will receive a higher dose than the first group, if no intolerable side effects were seen.
The dose of gemcitabine and/or erlotinib hydrochloride will be the same for every group.
Study Drug Administration:
If you are in Arm A, on Days 1, 8, and 15 of each 28-day study cycle, you will receive gemcitabine through a needle into your vein over about 1 1/2 hours. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
If you are in Arm B, you will take erlotinib hydrochloride by mouth once a day (in the morning) every day. You should take it with about 1 cup (8 oz.) of water 1 hour before or 2 hours after eating. On Days 1, 8, and 15 of each cycle, you will receive gemcitabine by vein over about 1 1/2 hours. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
Depending upon how well you tolerate gemcitabine, your doctor may decide that you should receive gemcitabine on Days 1 and 15 instead of Days 1, 8, and 15.
Study Visits:
On Day 1 of Cycle 1, the following tests and procedures will be performed:
On Day 8 of Cycle 1, the following tests and procedures will be performed:
On Day 15 of Cycle 1, the following tests and procedures will be performed:
On Day 22 of Cycle 1, the following tests and procedures will be performed:
On Day 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
On Days 8 and 15 of Cycles 2 and beyond, the following tests and procedures will be performed:
On Day 22 of Cycles 2 and beyond, your vital signs and weight will be measured and you will be asked if you have experienced any side effects.
On Day 22 of Cycle 2 and every even cycle (Cycles 4, 6, 8, and so on), you will have a CT scan or MRI scan to check the status of the disease. Blood (about 1 teaspoon) will also be drawn to test HAHA.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit, the following tests and procedures will be performed:
At Weeks 4, 8, and 12 after the end of study visit, blood (about 1 teaspoon) will be drawn to test HAHA.
Long-Term Follow Up:
Once you are off study, every 3 months from then on, the study staff will ask you how you are doing, either in the clinic or by telephone. If you are called, the phone call will take about 10-15 minutes.
This is an investigational study. MK-0646 is not FDA approved or commercially available. At this time, MK-0646 is only being used in research. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of pancreatic cancer in combination with gemcitabine.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Phase II:
The Study Drugs:
MK-0646 is designed to block proteins that are thought to cause cancer cells to grow and spread. This drug may help slow the growth of tumors.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Erlotinib hydrochloride is designed to block the activity of a protein found on the surface of many tumor cells that may control the growth and survival of cancer cells. This may stop cancer cells from growing.
Study Groups:
If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of the dice) into 1 of 3 groups.
Study Drug Administration:
If you are in Arm A, on Days 1, 8, and 15 of each 28-day study cycle, you will receive gemcitabine through a needle into your vein over about 1 1/2 hours as an infusion once a week for 3 weeks. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
If you are in Arm B, you will take erlotinib hydrochloride by mouth once (in the morning) every day. On Days 1, 8, and 15 of each cycle, you will receive gemcitabine by vein over about 1 1/2 hours. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
If you are in Arm C, you will take erlotinib hydrochloride by mouth once (in the morning) every day. On Days 1, 8, and 15 of each cycle, you will receive gemcitabine by vein over about 1 1/2 hours.
If you are taking erlotinib hydrochloride, you should take it with about 1 cup (8 oz.) of water 1 hour before or 2 hours after eating.
Depending upon how well you tolerate gemcitabine, your doctor may decide that you should receive gemcitabine on Days 1 and 15 instead of Days 1, 8, and 15.
Study Visits:
On Day 1 of Cycle 1, the following tests and procedures will be performed:
On Day 8 of Cycle 1, the following tests and procedures will be performed:
On Day 15 of Cycle 1, the following tests and procedures will be performed:
On Day 22 of Cycle 1, the following tests and procedures will be performed if you are receiving MK-0646:
On Day 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
On Days 8 and 15 of Cycles 2 and beyond, the following tests and procedures will be performed:
On Day 22 of Cycles 2 and beyond, your vital signs and weight will be measured, (if you are receiving MK-0646). and you will be asked if you have experienced any side effects.
On Day 22 of Cycle 2 and every even cycle (Cycles 4, 6, 8, and so on), you will have a CT scan or MRI scan to check the status of the disease. Blood (about 1 teaspoon) will be also be drawn to test HAHA if you are receiving MK-0646.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
If you are in Arm C (erlotinib and gemcitabine) and the disease gets worse, you may be allowed to join Arm B (gemcitabine, erlotinib, and MK-0646).
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit the following tests and procedures will be performed:
At Weeks 4, 8, and 12 after the end of study visit, blood (about 1 teaspoon) will be drawn to test HAHA if you were receiving MK-0646.
Long-Term Follow Up:
Once you are off study, every 3 months from then on, the study staff will ask you how you are doing, either in the clinic or by telephone. If you are called, this phone call will take about 10-15 minutes.
This is an investigational study. MK-0646 is not FDA approved or commercially available. At this time, MK-0646 is only being used in research. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer. Erlotinib hydrochloride is FDA approved and commercially available for the treatment of pancreatic cancer in combination with gemcitabine.
Up to 100 patients will take part in this study. All will be enrolled at MD Anderson.
Phase II Expansion Cohort:
The Study Drugs:
MK-0646 is designed to block proteins that are thought to cause cancer cells to grow and spread. This drug may help slow the growth of tumors.
Gemcitabine is designed to disrupt the growth of cancer cells, which may cause cancer cells to die.
Study Treatments:
If you are found to be eligible to take part in this study, you will receive gemcitabine and MK-0646.
Study Drug Administration:
On Days 1, 8, and 15 of each 28-day study cycle, you will receive gemcitabine through a needle into your vein over about 1 1/2 hours as an infusion once a week for 3 weeks. On Days 1, 8, 15, and 22 of each cycle, you will receive MK-0646 by vein over 1 hour.
Depending upon how well you tolerate gemcitabine, your doctor may decide that you should receive gemcitabine on Days 1 and 15 instead of Days 1, 8, and 15.
Study Visits:
On Day 1 of Cycle 1, the following tests and procedures will be performed:
On Day 8 of Cycle 1, the following tests and procedures will be performed:
On Day 15 of Cycle 1, the following tests and procedures will be performed:
On Day 22 of Cycle 1, the following tests and procedures will be performed if you are receiving MK-0646:
On Day 1 of Cycles 2 and beyond, the following tests and procedures will be performed:
On Days 8 and 15 of Cycles 2 and beyond, the following tests and procedures will be performed:
On Day 22 of Cycles 2 and beyond, your vital signs and weight will be measured and you will be asked if you have experienced any side effects.
On Day 22 of Cycle 2 and every even cycle (Cycles 4, 6, 8, and so on), you will have a CT scan or MRI scan to check the status of the disease.
Length of Study:
You may remain on study for as long as you are benefiting. You will be taken off study if the disease gets worse or you experience intolerable side effects.
End-of-Study Visit:
After you go off study, you will have an end-of-study visit. At this visit the following tests and procedures will be performed:
Long-Term Follow Up:
Once you are off study, every 3 months from then on, the study staff will ask you how you are doing, either in the clinic or by telephone. If you are called, this phone call will take about 10-15 minutes.
This is an investigational study. MK-0646 is not FDA approved or commercially available. At this time, MK-0646 is only being used in research. Gemcitabine is FDA approved and commercially available for the treatment of pancreatic cancer.
Up to 100 patients total will take part in this study. All will be enrolled at MD Anderson.
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase I, Arm A | Experimental | MK-0646 + Gemcitabine |
|
| Phase I, Arm B | Experimental | MK-0646 + Gemcitabine + Erlotinib |
|
| Phase II, Arm A | Experimental | Gemcitabine + Erlotinib |
|
| Phase II, Arm B | Experimental | MK-0646 + Gemcitabine + Erlotinib |
|
| Phase II, Arm C | Experimental | Gemcitabine + Erlotinib |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0646 | Drug | Starting Dose Level: 5 mg/kg given intravenously over 60 minutes Days 1, 8, 15, 22 of 28 Day Cycle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| MK-0646 Maximum Tolerable Dose | MK-0646 10 mg/kg was declared to be the MTD in combination with gemcitabine and 5 mg/kg the MTD in combination with Gemcitabine and erlotinib | up to 12 cycles |
| Progression Free Survival | Time interval (in months) from date of randomization until the date of first documented progression or date of death from any cause, whichever came first | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Time interval (in months) from date of randomization until the date of death from any cause | From date of randomization until the date of death from any cause, assessed up to 100 months |
| Overall Response Rate |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation Between Tissue IGF-I Expression in Patients Treated With MK-0646 and OS | IGF1 expression in tissue was measured and correlated with 1 year patients survival. Inadequate biopsy data for outcome measure. | After completing treatment |
| Correlation Between Plasma IGF-I Expression in Patients Treated With MK-0646 and OS |
Inclusion Criteria:
Exclusion Criteria:
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Milind Javle, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29843755 | Derived | Abdel-Wahab R, Varadhachary GR, Bhosale PR, Wang X, Fogelman DR, Shroff RT, Overman MJ, Wolff RA, Javle M. Randomized, phase I/II study of gemcitabine plus IGF-1R antagonist (MK-0646) versus gemcitabine plus erlotinib with and without MK-0646 for advanced pancreatic adenocarcinoma. J Hematol Oncol. 2018 May 30;11(1):71. doi: 10.1186/s13045-018-0616-2. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
Not provided
Not provided
Completed, last patient enrolled in September 26th, 2013
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm A / Phase I | Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. |
| FG001 | Arm B / Phase I | Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. |
| FG002 | Arm A / Phase II Randomization | Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg |
| FG003 | Arm B / Phase II Randomization | Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg |
| FG004 | Arm C / Phase II Randomization | Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily |
| FG005 | Phase II Expansion | MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm A / Phase I | Arm A: MK-0646 (MK) + gemcitabine(G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. . |
| BG001 | Arm B / Phase I |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | MK-0646 Maximum Tolerable Dose | MK-0646 10 mg/kg was declared to be the MTD in combination with gemcitabine and 5 mg/kg the MTD in combination with Gemcitabine and erlotinib | The primary endpoint is MTD which was analyzed based on phase I participants only. Phase II (Arms A and B) or phase II expansion participants were not included in the analysis per design. | Posted | Number | participants | up to 12 cycles |
|
assessed up to 100 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A / Phase I | Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| G4 thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Milind Javle, MD/Professor, GI Medical Oncology | UT MD Anderson Cancer Center | 713-792-2828 | mjavle@mdanderson.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 6, 2014 | Nov 10, 2017 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| C569480 | dalotuzumab |
| D000093542 | Gemcitabine |
| D000069347 | Erlotinib Hydrochloride |
| ID | Term |
|---|---|
| D006571 | Heterocyclic Compounds |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
Not provided
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Not provided
Not provided
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| Gemcitabine | Drug | 1000 mg/m^2 given intravenously over 1-1/2 hours Days 1, 8, and 15 of each 28 Day Cycle. |
|
|
| Erlotinib | Drug | 100 mg by mouth daily. |
|
|
Complete response + Partial response using RECIST (Response Evaluation Criteria in Solid Tumors)
| From start of the treatment until disease progression/recurrence; or through study completion (average of 1 year) |
| Treatment Toxicity | Number of patients who developed toxicity from treatment according to the National Cancer Institute's Common Terminology Criteria | Through the treatment cycles |
IGF1 expression in plasma was measured in patients and correlated with 1 year patients survival. Inadequate biopsy data for outcome measure. |
| After completing treatment |
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. |
| BG002 | Arm A / Phase II Randomization | Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg |
| BG003 | Arm B / Phase II Randomization | Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg |
| BG004 | Arm C / Phase II Randomization | Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily |
| BG005 | Phase II Expansion | MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22.
| OG002 | Arm A / Phase II Randomization | Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg |
| OG003 | Arm B / Phase II Randomization | Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg |
| OG004 | Arm C / Phase II Randomization | Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily |
| OG005 | Phase II Expansion | MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg |
|
|
| Primary | Progression Free Survival | Time interval (in months) from date of randomization until the date of first documented progression or date of death from any cause, whichever came first | For any group that was not analyzed for Progression Free Survival (PFS) outcome the number of participants has been set to be zero. | Posted | Median | 95% Confidence Interval | months | From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months |
|
|
|
| Secondary | Overall Survival | Time interval (in months) from date of randomization until the date of death from any cause | For any group that was not analyzed for Overall Survival (OS) outcome the number of participants has been set to be zero. | Posted | Median | 95% Confidence Interval | months | From date of randomization until the date of death from any cause, assessed up to 100 months |
|
|
|
| Secondary | Overall Response Rate | Complete response + Partial response using RECIST (Response Evaluation Criteria in Solid Tumors) | For any group that was not analyzed for Overall Response Rate outcome the number of participants has been set to be zero. | Posted | Count of Participants | Participants | From start of the treatment until disease progression/recurrence; or through study completion (average of 1 year) |
|
|
|
| Secondary | Treatment Toxicity | Number of patients who developed toxicity from treatment according to the National Cancer Institute's Common Terminology Criteria | Posted | Count of Participants | Participants | No | Through the treatment cycles |
|
|
|
| Other Pre-specified | Correlation Between Tissue IGF-I Expression in Patients Treated With MK-0646 and OS | IGF1 expression in tissue was measured and correlated with 1 year patients survival. Inadequate biopsy data for outcome measure. | Not Posted | After completing treatment | Participants |
| Other Pre-specified | Correlation Between Plasma IGF-I Expression in Patients Treated With MK-0646 and OS | IGF1 expression in plasma was measured in patients and correlated with 1 year patients survival. Inadequate biopsy data for outcome measure. | Not Posted | After completing treatment | Participants |
| 9 |
| 9 |
| 0 |
| 9 |
| 9 |
| 9 |
| EG001 | Arm B / Phase I | Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: intravenously at two dose levels: 5 mg/kg (level I) or 10 mg/kg (level II) on D1,8,15,22. | 12 | 12 | 2 | 12 | 12 | 12 |
| EG002 | Arm A / Phase II Randomization | Arm A: MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg | 15 | 15 | 2 | 15 | 15 | 15 |
| EG003 | Arm B / Phase II Randomization | Arm B: MK-0646 (MK) + gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily MK dose: 5 mg/kg | 15 | 15 | 4 | 15 | 15 | 15 |
| EG004 | Arm C / Phase II Randomization | Arm C: gemcitabine (G) + Erolotinib (E) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle E dose: 100 mg orally daily | 15 | 15 | 1 | 15 | 12 | 15 |
| EG005 | Phase II Expansion | MK-0646 (MK) + gemcitabine (G) G dose: 1000 mg/m2 over 100 min on D1,8,15 of a 28-day cycle MK dose: 10 mg/kg | 9 | 9 | 1 | 9 | 9 | 9 |
| G4 neutropenia for ≥7 days | Blood and lymphatic system disorders | CTCAE (3.0) | Non-systematic Assessment |
|
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated ALK | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated ALT | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated AST | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Elevated INR | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyperkalemia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Hyponatremia | Investigations | CTCAE (3.0) | Systematic Assessment |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Other cardiac toxicity | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperglycemia | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| GIT hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Thrombosis | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pulmonary embolism | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D011799 | Quinazolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
|