Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT00101894
First received: January 18, 2005
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to characterize the safety and tolerability of AMG 706 plus panitumumab when administered with either FOLFIRI or FOLFOX4 chemotherapy regimens. This is a Phase 1b clinical study.


Condition Intervention Phase
Rectal Cancer
Colon Cancer
Drug: FOLFOX-4
Drug: AMG 706
Biological: Panitumumab (Part 1a only)
Drug: FOLFIRI
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label, Dose-Finding Study to Evaluate the Safety of AMG 706 Plus Panitumumab Plus Chemotherapy in the Treatment of Subjects With Metastatic Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Amgen:

Primary Outcome Measures:
  • Part 1a - The incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities [ Time Frame: First 2 cycles ] [ Designated as safety issue: Yes ]
  • Part 1b - The incidence of adverse events and clinical laboratory abnormalities defined as dose-limiting toxicities [ Time Frame: First 2 cycles ] [ Designated as safety issue: Yes ]
  • Part 2 - The overall objective tumor response rate (complete and partial response) in subjects treated with AMG 706 (at the dose determined in Part 1b), with either the FOLFIRI or FOLFOX-4 chemotherapy regimen [ Time Frame: Every 8 weeks (+/- 7 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Part 1a - The PK of irinotecan (and its active metabolite SN38) when administered as a part of the FOLFIRI regimen with panitumumab and AMG 706 [ Time Frame: Cycle 1 and 2 (Days 1, 2, 3) ] [ Designated as safety issue: No ]
  • Part 1a - The PK of oxaliplatin when administered as a part of the FOLFOX-4 regimen with panitumumab and AMG 706 [ Time Frame: Cycle 1 and 2 (Day 1) ] [ Designated as safety issue: No ]
  • Part 1a - The objective tumor response rate (complete and partial response) throughout the study [ Time Frame: Every 6 to 8 weeks ] [ Designated as safety issue: No ]
  • Part 1b - The incidence of adverse events and clinical laboratory abnormalities not defined as dose-limiting toxicities [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
  • Part 1b - The PK of AMG 706 when administered with either the FOLFIRI or FOLFOX-4 chemotherapy regimen [ Time Frame: Cycle 2 (Day 1-2), Cycle 3 (Day 1) ] [ Designated as safety issue: No ]
  • Part 1b - The PK of 5-FU when administered as a part of the FOLFIRI or FOLFOX-4 regimen with AMG 706 [ Time Frame: Cycle 1 and 2 (Day 3) ] [ Designated as safety issue: No ]
  • Part 2 - Duration of response: (Calculated for only those subjects who respond) [ Time Frame: Time from first objective tumor response (subsequently confirmed at least 4 weeks later) to objective disease progression or death. ] [ Designated as safety issue: No ]
  • Part 2 - Time-to-progression [ Time Frame: Time from first dose of investigational product to objective disease progression or death due to disease progression. ] [ Designated as safety issue: No ]
  • Part 1b - The PK of irinotecan (and its active metabolite SN38) when administered as a part of the FOLFIRI regimen with AMG 706 [ Time Frame: Cycle 1 and 2 (Days 1, 2, 3) ] [ Designated as safety issue: No ]
  • Part 1b- The PK of oxaliplatin when administered as a part of the FOLFOX-4 regimen with AMG 706 [ Time Frame: Cycle 1 and 2 (Day 1) ] [ Designated as safety issue: No ]
  • Part 1b - The objective tumor response rate (complete and partial response) throughout the study [ Time Frame: Every 8 weeks (+/- 7 days) ] [ Designated as safety issue: No ]
  • Part 2 - Overall survival [ Time Frame: Time from first dose of investigational product to death. Subjects who have not died while on study or are lost to follow-up will be censored at their last contact date. (Time on study plus 36 months of long term follow-up) ] [ Designated as safety issue: No ]
  • Part 2 - The incidence of adverse events and clinical laboratory abnormalities [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
  • Part 2 - The PK of AMG 706 when administered with either the FOLFIRI or FOLFOX-4 chemotherapy regimen (at a subset of the study centers with the capabilities to draw, ship and process PK samples) [ Time Frame: Cycles 2, 4, 7, and every 3 subsequent cycles (Day 1) ] [ Designated as safety issue: No ]
  • Exploratory - Potential biomarker development based on assessment of blood cells, tumor cells, and urine and the proposed mechanism of action of study drugs, and response [ Time Frame: Day 1 of cycles 1 and 2, and within 7 days of a radiographic assessment ] [ Designated as safety issue: No ]
  • Exploratory - The effects of genetic variation in drug metabolism genes, cancer genes, and drug target genes on subject response to investigational products (separate informed consent) [ Time Frame: Day 1 of cycles 1 and 2, and within 7 days of a radiographic assessment ] [ Designated as safety issue: No ]
  • Part 2 - Progression-free survival time [ Time Frame: Time from first dose of investigational product to objective disease progression or death, subjects who have not progressed or died while on study will be censored at their last evaluable assessment date. ] [ Designated as safety issue: No ]
  • Part 2 - Incidence of subjects undergoing resection of metastases for curative intent [ Time Frame: As needed ] [ Designated as safety issue: Yes ]
  • Part 1a - The incidence of adverse events and clinical laboratory abnormalities not defined as dose-limiting toxicities [ Time Frame: Every visit ] [ Designated as safety issue: Yes ]
  • Part 1a - The PK of AMG 706 when administered with panitumumab and either the FOLFIRI or FOLFOX-4 chemotherapy regimen [ Time Frame: Cycle 2 (Day 1-2), Cycle 3 (Day 1) ] [ Designated as safety issue: No ]
  • Part 1a - The serum concentration of panitumumab when administered with AMG 706 and either the FOLFIRI or FOLFOX-4 chemotherapy regimen [ Time Frame: Cycle 1 (Day 1), Cycle 2 (Day 1), Cycle 4 (Day 1) ] [ Designated as safety issue: No ]
  • Part 1a - The incidence of HAPA response following panitumumab administration [ Time Frame: Cycle 1 (Day 1), Cycle 4 (Day 1), End of Study ] [ Designated as safety issue: Yes ]
  • Part 1a - The PK of 5-FU when administered as a part of the FOLFIRI or FOLFOX-4 regimen with panitumumab and AMG 706 [ Time Frame: Cycle 1 and 2 (Day 3) ] [ Designated as safety issue: No ]

Enrollment: 119
Study Start Date: December 2004
Study Completion Date: December 2011
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Part 2 AMG 706 (MTD) + FOLFOX-4
Maximum Tolerated Dose of AMG 706 established in Part 1b + FOLFOX-4
Drug: FOLFOX-4

The FOLFOX-4 regimen will be administered every 2 weeks as follows:

Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed

Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Experimental: 125 mg QD AMG 706 + FOLFOX-4
125 mg QD AMG 706 + FOLFOX-4
Drug: FOLFOX-4

The FOLFOX-4 regimen will be administered every 2 weeks as follows:

Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed

Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Experimental: 50 mg QD AMG706 + panitumumab + FOLFIRI
50 mg QD AMG706 + panitumumab + FOLFIRI
Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Biological: Panitumumab (Part 1a only)
Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.
Drug: FOLFIRI
Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.
Experimental: Part 2 AMG 706 (MTD) + FOLFIRI
Maximum Tolerated Dose of AMG 706 established in Part 1b + FOLFIRI
Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Drug: FOLFIRI
Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.
Experimental: 100 mg QD AMG 706 + FOLFIRI
100 mg AMG 706 + FOLFIRI
Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Drug: FOLFIRI
Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.
Experimental: 75 mg QD AMG 706 + panitumumab + FOLFOX-4
75 mg QD AMG 706 + panitumumab + FOLFOX-4
Drug: FOLFOX-4

The FOLFOX-4 regimen will be administered every 2 weeks as follows:

Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed

Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Biological: Panitumumab (Part 1a only)
Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.
Experimental: 75 mg BID AMG 706 + panitumumab + FOLFIRI
75 mg BID AMG 706 + panitumumab + FOLFIRI
Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Biological: Panitumumab (Part 1a only)
Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.
Drug: FOLFIRI
Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.
Experimental: 125 mg QD AMG 706 + panitumumab + FOLFIRI
125 mg QD AMG 706 + panitumumab + FOLFIRI
Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Biological: Panitumumab (Part 1a only)
Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.
Drug: FOLFIRI
Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.
Experimental: 125 mg QD AMG 706 + FOLFIRI
125 mg QD AMG 706 + FOLFIRI
Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Drug: FOLFIRI
Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.
Experimental: 100 mg QD AMG 706 + panitumumab + FOLFIRI
100 mg QD AMG 706 + panitumumab + FOLFIRI
Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Biological: Panitumumab (Part 1a only)
Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.
Drug: FOLFIRI
Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.
Experimental: 75 mg QD AMG 706 + FOLFOX-4
75 mg QD AMG 706 + FOLFOX-4
Drug: FOLFOX-4

The FOLFOX-4 regimen will be administered every 2 weeks as follows:

Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed

Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Experimental: 100 mg QD AMG 706 + FOLFOX-4
100 mg QD AMG 706 + FOLFOX-4
Drug: FOLFOX-4

The FOLFOX-4 regimen will be administered every 2 weeks as follows:

Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed

Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Experimental: 50 mg QD AMG 706 + panitumumab + FOLFOX-4
50 mg QD AMG 706 + panitumumab + FOLFOX-4
Drug: FOLFOX-4

The FOLFOX-4 regimen will be administered every 2 weeks as follows:

Day 1: oxaliplatin (ELOXATIN™) 85 mg/m2 IV infusion and leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion given over 120 ± 10 minutes at the same time in separate bags using a Y-line, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed by 5-FU 600 mg/m2 IV infusion as a 22-hour ± 2 hours continuous infusion Day 2: leucovorin racemate 200 mg/m2 (or 100 mg/m2 l-LV) IV infusion over 120 ± 10 minutes, followed by 5-FU 400 mg/m2 IV bolus given over 2 to 4 minutes, followed

Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Biological: Panitumumab (Part 1a only)
Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.
Experimental: 75 mg QD AMG706 + panitumumab + FOLFIRI
75 mg QD AMG706 + panitumumab + FOLFIRI
Drug: AMG 706
AMG 706 is a small organic molecule that has been shown in preclinical pharmacology studies to be a potent, oral, multi-kinase inhibitor with anti-angiogenic and anti-tumor activity achieved by selectively inhibiting all known VEGF receptors, PDGF receptor, and Kit.
Biological: Panitumumab (Part 1a only)
Panitumumab will be administered by IV infusion at a dose of 6 mg/kg on day 1 of each 2-week cycle.
Drug: FOLFIRI
Irinotecan will be administered over 90 minutes ± 15 minutes on day 1 of each 2-week cycle. Leucovorin will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing, immediately followed by a 5-FU bolus and a 5-FU 46-hour ± 2-hour continuous intravenous infusion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

For complete inclusion and exclusion criteria, please refer to the investigator. Inclusion Criteria

  1. Competent to comprehend, sign, and date an Institutional Review Board (IRB) approved informed consent form
  2. Diagnosis of metastatic colorectal adenocarcinoma (may have received 1 prior chemotherapy regimen for metastatic CRC)
  3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  4. Adequate hematological function
  5. Adequate renal function
  6. Adequate hepatic function
  7. Life expectancy of greater than or equal to 3 months as documented by the investigator

Exclusion Criteria:

  1. More than 1 prior chemotherapy regimen for metastatic CRC
  2. Central nervous system (CNS) metastases
  3. History of venous thrombosis
  4. Myocardial infarction, cerebrovascular accident, transient ischemic attack, grade 2 or greater peripheral vascular disease, congestive heart failure, ongoing arrhythmias requiring medication, or unstable angina within 1 year before study enrollment
  5. History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on screening chest computed tomograph (CT) scan
  6. Average systolic blood pressure > 150mm Hg or average diastolic blood pressure of > 90mm Hg
  7. Radiotherapy within 28 days of study enrollment or within 14 days of study enrollment for peripheral lesions
  8. Prior AMG 706, oral inhibitors of AMG706, panitumumab, or another anti-EGFr monoclonal antibody (mAb) (e.g., cetuximab [Erbitux®] or EMD 72000)
  9. Systemic chemotherapy within 28 days before study enrollment
  10. Major surgery within 28 days or minor surgery within 7days of study enrollment
  11. History of life threatening ventricular arrhythmia (eg, sustained ventricular tachycardia)
  12. Female and male subjects of childbearing potential not using adequate contraceptive precautions
  13. Participation in therapeutic clinical trials within 30 days before study enrollment
  14. Not recovered from all previous therapies
  15. Clinically significant open would, ulcer or fracture
  16. Any co-morbid medical condition that would increase the risk of toxicity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00101894

Sponsors and Collaborators
Amgen
Investigators
Study Director: MD Amgen
  More Information

Additional Information:
No publications provided

Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT00101894     History of Changes
Obsolete Identifiers: NCT00107328
Other Study ID Numbers: 20040205
Study First Received: January 18, 2005
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Amgen:
AMG 706
Panitumumab

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014