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Last Updated: September 18, 2020

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CLINICAL TRIALS PROFILE FOR RAF-265

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Clinical Trials for RAF-265

Trial ID Title Status Sponsor Phase Summary
NCT00003236 Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer Completed National Cancer Institute (NCI) Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of ISIS 5132 with ISIS 3521 in treating women who have metastatic breast cancer that has not responded to previous therapy.
NCT00003236 Chemotherapy in Treating Women With Previously Treated Metastatic Breast Cancer Completed Eastern Cooperative Oncology Group Phase 2 RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Randomized phase II trial to compare the effectiveness of ISIS 5132 with ISIS 3521 in treating women who have metastatic breast cancer that has not responded to previous therapy.
NCT00024648 Study to Determine Maximum Tolerated Dose of LErafAON Combined With Radiotherapy in Patients With Advanced Malignancies Completed Georgetown University Phase 1 LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein produced by human cells, both normal and cancerous, which may help protect tumor cells from radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy. Patients with advanced malignancies will receive daily IV infusions of LErafAON for 2 weeks (total of 10 doses) during clinically indicated palliative radiotherapy. Cohorts of at least three patients will be entered at escalating dose-levels. Each cohort will be observed for toxicity for at least two weeks after completion of treatment with study medication before the next cohort is enrolled. The study will be stopped when a maximum tolerated dose (MTD) is identified. Dose escalation within a patient will not be allowed. Safety and supportive care requirements will be assessed.
NCT00024648 Study to Determine Maximum Tolerated Dose of LErafAON Combined With Radiotherapy in Patients With Advanced Malignancies Completed INSYS Therapeutics Inc Phase 1 LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein produced by human cells, both normal and cancerous, which may help protect tumor cells from radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy. Patients with advanced malignancies will receive daily IV infusions of LErafAON for 2 weeks (total of 10 doses) during clinically indicated palliative radiotherapy. Cohorts of at least three patients will be entered at escalating dose-levels. Each cohort will be observed for toxicity for at least two weeks after completion of treatment with study medication before the next cohort is enrolled. The study will be stopped when a maximum tolerated dose (MTD) is identified. Dose escalation within a patient will not be allowed. Safety and supportive care requirements will be assessed.
NCT00024661 Study to Determine the Maximum Tolerated Dose of LErafAON in Patients With Advanced Solid Tumors Completed Georgetown University Phase 1 LErafAON is a liposome encapsulated c-raf antisense oligonucleotide. Raf-1 is a protein produced by human cells, both normal and cancerous, which may help protect tumor cells from radiation. Antisense oligonucleotides are very specific drugs, which can decrease the amount of a certain target protein by blocking the gene that makes it. Antisense oligonucleotide to raf gene can reduce the amount of Raf-1 protein in tumor cells. Liposomes are tiny globules of fat, which can carry drugs in the body. The experimental agent LErafAON is composed of liposomes carrying antisense oligonucleotide against the Raf-1 protein. It is hoped that decreased Raf-1 in the cancer cells will make them more sensitive to the radiation therapy. Patients with advanced solid tumors will receive IV infusions of LErafAON over at least 60 minutes, once per week, for 8 weeks. In the absence of progression, patients may continue on weekly treatment. Pre-medications will be administered prior to each dose of study medication. Cohorts of at least three patients will be entered at escalating dose-levels. Each cohort will be observed for at least ten days after receiving the first dose of treatment before additional patients are treated at a higher dose level. Patients will be followed for one month after receiving the last dose of study medication. The study will stop when a maximum tolerated dose (MTD) is identified. Dose escalation within a patient will not be allowed.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for RAF-265

Condition Name

Condition Name for
Intervention Trials
Colorectal Cancer 16
Melanoma 12
Recurrent Melanoma 9
Metastatic Colorectal Cancer 8
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Condition MeSH

Condition MeSH for
Intervention Trials
Melanoma 41
Colorectal Neoplasms 32
Carcinoma 27
Lung Neoplasms 16
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Clinical Trial Locations for RAF-265

Trials by Country

Trials by Country for
Location Trials
United States 589
Germany 31
Canada 22
United Kingdom 21
Italy 20
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Trials by US State

Trials by US State for
Location Trials
California 35
Texas 34
Maryland 32
New York 29
Massachusetts 29
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Clinical Trial Progress for RAF-265

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 3
Phase 3 4
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 87
Recruiting 55
Active, not recruiting 25
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Clinical Trial Sponsors for RAF-265

Sponsor Name

Sponsor Name for
Sponsor Trials
National Cancer Institute (NCI) 73
Bayer 12
Novartis Pharmaceuticals 7
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Sponsor Type

Sponsor Type for
Sponsor Trials
Other 166
Industry 100
NIH 73
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