Phase I Studies

Clinical Trials

2009-415

Title: A Phase I Study of LY2801653 in Patients with Advanced Cancer.

Description: People with advanced cancer that has not responded to standard treatment or for which there is no standard treatment are being asked to participate in this study.

The purpose of this study is to test the safety of LY2801653 at different dose levels. We want to find out how LY2801653 is distributed, broken down, and passed out of the body. We want to find out what effects (good and bad) it has on advanced cancer.

For more information on this trial from ClinicalTrials.gov, click here!

2010-022

Title: ABT-888 as monotherapy and in combination with Mitomycin C in patients with solid tumors with deficiency in homologous recombination repair.

Description: This study is for patients with any solid tumor who do not have a curative or standard treatment option available. In step 1 of the study previously collected tumor tissue will be tested to find out how efficient the tumor is in repairing damage produced by chemotherapy. This is done by measuring the formation of repair foci, called FancD2 nuclear foci) in tumor samples. Only patients whose tumor has no FancD2 nuclear foci will be eligible for the treatment part of this study, which is step 2.

In step 2 of the study, patients will be assigned to either Arm 1 or Arm 2 treatment. Patients in Arm 1 will receive the investigational drug ABT-888 alone. ABT-888 is a pill that is taken by mouth. Patients in Arm 2 will receive ABT-888 in combination with the standard chemotherapy drug Mitomycin C. Mitomycin C is given by vein. 

The purpose of this study is to find out what dose and schedule of the drugs, ABT-888 alone or ABT-888 and Mitomycin C are safe to use in patients with solid tumor cancer. This study will also find out what side effects, good or bad are associated with taking ABT-888 alone or with Mitomycin C. Another purpose of this study is to study how these drugs affect cancer cells. This will be done by doing special laboratory tests on several blood samples taken during the course of the treatment.

For more information on this trial from ClinicalTrials.gov, click here!

2010-533

Title: A Phase I Study of the HER1, HER2 Dual Kinase Inhibitor Lapatinib plus the Proteasomal Inhibitor Bortezomib in Patients with Advanced Malignancies.

Description: This study is for patients with an advanced solid tumor for which no curative treatment exists. The purpose of this study is to test the safety and efficacy of the combination of the study drugs, Lapatinib and Bortezomib. Lapatinib is a drug that targets two proteins important for the growth of cancer cells known as HER1 (EGFR) and HER2. By inhibiting these proteins, Lapatinib can inhibit cancer cell growth and even lead to their death. Lapatinib is an oral pill, given by mouth once every day. Lapatnib is approved by the FDA for patients with breast cancer. Bortezomib is a drug that targets a part of cancer cells known as the proteosome. By inhibiting the proteosome, Bortezomib can inhibit cancer cell growth and even lead to their death. Bortezomib is given intravenously, once a week, 2 out of every 3 weeks. Bortezomib is approved by the FDA for patients with multiple myeloma and mantle cell lymphoma. This research is being done because it is not known if the combination of Lapatinib and Bortezomib will work better than Lapatinib or Bortezomib alone, although in the lab and in animal studies the combination of the two drugs was much more effective than either drug alone, giving us hope for additional benefit with the combination. As part of this study biopsies will be taken of patients' tumors before any treatment, after starting with the Lapatinib alone, and after receiving both the Lapatinib and Bortezomib. We want to investigate what markers inside tumors may relate to how well these two medications work. These biopsies are required as part of the study.

For more information on this trial from ClinicalTrials.gov, click here!

2011-160

Title: A Phase I Study of PF-05082566 as a Single Agent in Patients with Advanced Cancer, and in Combination with Rituximab in Patients with Non-Hodgkin's Lymphoma (NHL).

Description: This study is for patients with advanced cancer that is no longer responsive to standard anti-cancer therapies. The purpose of this study is to learn about the effects of the study drug, PF-05082566, and to find out the best dose for treating solid tumors and/or B-cell lymphoma (Part A) and Non-Hodgkin?s lymphoma (Part B). In Part B, PF-05082566 will be given together with rituximab. PF-05082566 is a new investigational drug. An investigational drug is one that is currently not approved for sale in this country. PF-05082566 is an antibody, which is a type of protein, which has been shown in animal studies to stimulate the immune system. It is given as a 1 hour intravenous infusion once every 28 days. This will be the first time that PF-05082566 is being studied in humans.

For more information on this trial from ClinicalTrials.gov, click here!

2011-219

Title: A Phase I Study of the CDK4/6 Inhibitor PD-0332991, 5-Fluorouracil, and Oxaliplatin in Patients with Advanced Solid Tumors.

Description: This study is for patients with metastatic colorectal cancer (cancer that has spread to other parts of the body). The purpose of this study is to test the safety and effectiveness of a new combination of drugs, PD-0332991 and 5-Fluorouracil and Oxaliplatin for patients with metastatic colorectal cancer. PD-0332991 stops cells from dividing by blocking an enzyme called cyclin-dependent kinase (CDK), which cancer cells need to grow and divide. By inhibiting this enzyme, PD-0332991 prevents cancer cells from growing and dividing, while the 5-Fluorouracil and Oxaliplatin damage the cells, hopefully increasing the killing of cancer cells, thus decreasing the tumors in your body. PD-0332991 is an investigational or experimental anti-cancer agent that has not yet been approved by the Food and Drug Administration (FDA) for use in colorectal cancer. It is given as a pill which is taken once a day for one week followed by one week off. 5-Fluorouracil and Oxaliplatin are administered as an infusion into a vein once every 2 weeks and are approved for and used as chemotherapy for colorectal cancer.

For more information on this trial from ClinicalTrials.gov, click here!

2011-345

Title: A Phase 1 Study of a Combination of the Peroxisome Proliferator-Activated Receptor Gamma Agonist, CS-7017 and the Retinoid X Receptor Agonist, Bexarotene

Description: This study is for patients with advanced solid tumors. The purpose of this study is to test the safety and effectiveness of a new combination of drugs, CS-7017 and Bexarotene in patients with advanced cancer. Both these drugs have many effects on cancer cells, including stopping cancer cell growth and division, and causing the cancer cells to die. They work on cancer cells in a similar manner and both drugs together may have even a greater effect against cancer cells, hopefully increasing the killing of cancer cells.

CS-7017 is an investigational or experimental anti-cancer agent that as not been yet approved by the Food and Drug Administration (FDA) for use in any type of cancer. Bexarotene is an anti-cancer agent that has been approved for patients with a specific type of cancer, cutaneous T-cell lymphoma.

This study will help find out what effects the combination of drugs has on cancer. This research is being done because it is not known if CS-7017 is safe to be given with Bexarotene.

2013-0039

Title: A Phase I Study of the BCR-ABL Tyrosine Kinase Inhibitor Nilotinib and Cetuximab in Patients with Solid Tumors that can be Treated with Cetuximab.

Description: The purpose of this study is to determine the recommended Phase II dose of nilotinib when used in combination with cetuximab in the treatment of patients with recurrent and/or metastatic Kras wildtype colorectal cancer or squamous cell carcinoma of the head and neck.

For more information on this trial from ClinicalTrials.gov, click here!

2013-0342

Title: A Phase 1, Open-label, Dose-escalation Study of SNX-5422 plus Carboplatin and Paclitaxel in Subjects with Selected Solid Tumors

Description: This study is for patients with non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC)

The main purpose of this study is to determine the highest dose of SNX-5422 when combined with once every 3 weeks of both carboplatin and paclitaxel that can be tolerated when SNX-5422 is given once every other day for 21 days followed by a 1-week period (7 days) without study drug. SNX-5422 is an experimental drug that has not yet been approved by the US Food and Drug administration. Carboplatin and paclitaxel will be given as an IV infusion (through a needle in a vein) once every 3 weeks for a maximum of 4 times through the first 3 cycles of SNX-5422. After that SNX-5422 will be given alone as long as the lung cancer is not getting worse and the drug is tolerated without bad side effects. Other goals of this study are to study its side effects, to measure its possible effects on the tumor, and to further study how this drug works.

For more information on this trial from ClinicalTrials.gov, click here!

2013-1442

Title: Merck 028: Phase IB Study of MK-3475 in Subjects with Select Advanced Solid Tumors.

Description: This study is for patients with an advanced solid tumor that has failed prior treatment or for which no standard treatment exists.

The main purpose of this study is to:

  • Test the safety and tolerability of the research study drug, MK-3475.
  • To see if MK-3475 has anti-tumor activity in advanced solid tumors.

All subjects will receive MK-3475 as an intravenous infusion (through a needle in a vein) once every 2 weeks.

For more information on this trial from ClinicalTrials.gov, click here!

Pro-296

Title: GP28328: A Phase 1b Study of the Safety and Pharmacology of MPDL3280A Administered with Bevacizumab or with Bevacizumab plus FOLFOX in Patients with Advanced Solid Tumors.

Description: This study is for patients with cancer that is locally advanced or metastatic (grown or spread) that did not respond to previous treatment(s) or for which previous treatment(s) was stopped because the side effects were not tolerable. Patients with metastatic colorectal cancer that has not been previously treated with oxaliplatin may also take part in this study.

The purpose of this study is to find out whether an investigational drug called MPDL3280A can be safely used in combination with the standard drug bevacizumab or bevacizumab plus FOLFOX chemotherapy. 

The body's immune system has a certain natural ability to withstand tumor growth. Tumors partially resist the immune system using the PF-L1 pathway. By blocking the PD-L1 pathway, MPDL3280A may help the immune system to withstand the growth of tumors.

For more information on this trial from ClinicalTrials.gov, click here!

Pro-305

TitleCD-ON-MEDI4736-1108: A Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects with Advanced Solid Tumors.

Description: This study is for subjects with a type of cancer (or tumor) of the skin, kidney, lung, or colon that has not responded well to available (standard) therapies or for which no standard therapy exists.

MEDI4736 is an antibody that is made in the laboratory. An antibody is a natural protein made by the immune system that binds other proteins and molecules to fight infection and other foreign bodies (such as cancer). MEDI4736 is an experimental drug being tested in humans for the first time. MEDI4736 binds to another protein in the body and may prevent cancer growth by helping certain blood cells of the immune system eliminate the tumor.

The main purpose of this study is to determine the dose of MEDI4736 that is safe and tolerable in subjects with solid tumors. This study will also evaluate how much MEDI4736 is in the blood at various times, whether the immune system becomes activated following treatment or the body produces antibodies (proteins produced by your immune system) against MEDI4736, as well as the effect MEDI4736 has on cancer.

For more information on this trial from ClinicalTrials.gov, click here!

2014-0243

Title: A Phase I, Open-Label, Dose Escalation, Multi-Center Study of ACT-PFK-158, 2HCL in Patients with Advanced Solid Malignancies.

Description: This study is for patients with advanced solid tumors who have already received standard therapy for their cancer and either did not respond or their cancer came back.

This is the first time the study drug, PFK-158 is being given to humans. The purpose of this study is to determine the safe dose of the drug. PFK-158 is given as an infusion into a vein (intravenously) over 30-90 minutes three times a week for 3 weeks followed by one week with no drug given. This cycle will be repeated until disease progression or intolerable side effects.

For more information on this trial from ClinicalTrials.gov, click here!

2013-1344

Title: A Phase 1, Open-label, Dose-escalation Study of SNX-5422 and Everolimus in Subjects with Neuroendocrine Tumors

Description: This study will involve treatment with an experimental drug called SNX-5422 mesylate (referred to simply as SNX-5422). An experimental drug is one that has not been approved by the US Food and Drug Administration (FDA) and will not be approved until tests show the drug is safe (will not harm you) and effective (has good results).

The main purpose of this study is to determine the highest dose of SNX-5422 when combined with daily everolimus that can be tolerated when SNX-5422 is given once every other day for 21 days followed by a 1-week period (7 days) without study drug. Everolimus will be taken daily for 28 days. Other goals of this study are to study its side effects, to measure its possible effects on the tumor, and to further study how this drug works.

For more information on this trial from ClinicalTrials.gov, click here!

2013-1476

Title: MK-3475-029: A Phase I/II clinical trial to study the safety and tolerability of MK-3475 + pegylated interferon alfa-2b (PEG-IFN) and MK-3475 + ipilimumab (IPI) in subjects with advanced melanoma (MEL) and renal cell carcinoma (RCC).

Description: This study is for patients with advanced melanoma or renal cell carcinoma (kidney cancer). Two marketed drugs (PEG-IFN and IPI) will be tested with an experimental drug (MK-3475)

The trial consists of two parts: Part 1 will involve testing different doses of the drugs in combination; Part 2: will involve testing MK-3475 given alone.

For more information on this trial from ClinicalTrials.gov, click here!

2013-1338

Title: EMR 100070-001: A Phase I, Open-Label, Multiple-Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of MSB0010718C in Subjects with Metastatic or Locally Advanced Solid Tumors and Expansion to Selected Indications.

Description: There are two parts to this research trial: a dose escalation part and an expansion part. The main purpose of this research trial is to test MSB0010718C at different dose levels to see if it is safe and well tolerated when given once every two weeks. Based on this information and hope to learn which dose (drug strength) could be best for treatment of subjects. Additional purposes of the trial are to assess side effects of MSB0010718C and to find out whether MSB0010718C has anti-cancer effects. In addition, we would like to find out how MSB0010718C is processed by the body (this is called pharmacokinetic or PK research).

For more information on this trial from ClinicalTrials.gov, click here!

2014-0592

Title: A Phase 1/2a, Multicenter, Open-Label Study Of Oral RXDX-101 In Adult Patients With Locally Advanced Or Metastatic Cancer Confirmed To Be Positive For TRKA, TRKB, TRKC, ROS1, or ALK Molecular Alterations

Description: This study is for patients with cancer that is caused by a mistake in a part of the DNA that controls cell growth and death. In order to participate in this study subject's must have their tumor tissue tested to detect the DNA mistakes in the cancer cells to determine whether or not they are eligible for the study. The purpose of this study is to see if the study drug, RXDX-101 is safe and tolerable and can decrease the size of tumors based on cancer type and the DNA mistake(s) within the cancer cells. All subjects will take RXDX-101 capsules once a day every day until their tumor grows, they experience bad side effects or they decide to stop participating in the study. The exact dose each subject receives will be based upon when they enter the study and the side effects seen in subjects treated earlier in the study.

For more information on this trial from ClinicalTrials.gov, click here!

2014-0913

Title: G029313: A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 Administered Intravenously as a Single Agent to Patients with Locally Advanced or Metastatic Solid Tumors

Description: This study is for patients with a solid tumor cancer that has spread and did not respond to previous treatment(s) or for which previous treatment(s) was stopped because the side effects were not tolerable.

The purpose of this study is to test the safety and tolerability of an experimental drug called MOXR0916 in patients with locally advanced or metastatic solid tumors at different dose levels. We want to find out what dose of MOXR0916 should be used and what effects, good and/or bad, it has on cancer.

The use of MOXR0916 in this research study is experimental, which means that it is not approved by any regulatory body such as the U.S. Food and Drug Administration (FDA) for cancer treatment or any other disease.

MOXR0916 has not been used in humans before. All subjects on this study will receive MOXR0196 as an intravenous (through a needle in a vein) infusion once every 3 weeks. The dose an individual subject will receive will depend on when they enroll in the study and the side effects seen in subjects enrolled earlier in the trial.

For more information on this trial from ClinicalTrials.gov, click here!

2013-1195

Title: A Phase I Study of Ganetespib in Combination with Doxorubicin in Solid Tumors

DescriptionSubjects are being asked to participate in this study because they have an advanced cancer for which no curative option is available at this time.

The purpose of this study is to test the safety of the combination of the study drugs.

The main purpose of this study is to determine the maximum dosages that patients can tolerate when these two medicines are given at the same time. At the start of the treatment, we will keep the dose of doxorubicin constant, and increase the dose of ganetespib to determine the ‘maximum tolerated dose.’ Subjects will only be assigned one dose “level” of both drugs. The dose may be reduced if you have side-effects that necessitate such as reduction.

This research is also being done because it is not known if the combination of ganetespib and doxorubicin will work better than ganetespib or doxorubicin alone, although in the lab and in animal studies the combination of the two drugs was much more effective than either drug alone, giving us hope for additional benefit with the combination.

Advanced solid tumors for which no curative treatment option is available, and are refractory to standard therapies or for which no standard therapies exist. In fact, cancers refractory to doxorubicin may benefit from going on this trial, as the whole purpose of the trial is to see if we can overcome resistance to doxorubicin with the addition of ganetespib; usual guidelines for lifetime maximum dose of doxorubicin will be followed.

For more information on this trial from ClinicalTrials.gov, click here!

2014-1221

Title: Phase 1, Multiple Ascending Dose Study Of Anti-HER2 FCAB™ FS102 In HER2 Positive Solid Tumors

Description: The purpose of the study is to test the safety and tolerability of FS102, and to identify the most effective and tolerable dose. The study is also being conducted to identify how much FS102 is measured in the blood after it is administered, how FS102 affects cancer cells, and if it helps to improve cancer.

For more information on this trial from ClinicalTrials.gov, click here!

2014-1094

Title: A Phase I/II Dose Escalation and Cohort Expansion Study of the Safety, Tolerability and Efficacy of Anti-CD27 antibody (Varlilumab) Administered in Combination with Anti-PD-1 (Nivolumab) in Advanced Refractory Solid Tumors

DescriptionThis study is for people that have been diagnosed with unresectable (i.e., surgery is not an option to adequately treat the tumor) or metastatic (i.e., cancer that has spread to other parts of the body) non-small cell lung cancer, melanoma, colorectal cancer, ovarian cancer or head and neck cancer and have received no more than three anti-cancer treatments for advanced disease.

The purpose of this study is to test the effectiveness (how well the drug works), safety, and tolerability of the investigational drugs varlilumab and nivolumab together. This is the first time varlilumab and nivolumab have been tested together in humans. Varlilumab (also known as CDX-1127) and nivolumab (also known as BMS-936558) are antibodies (a type of human protein) that are manufactured in a laboratory and are being tested to see if they will allow the body’s immune system to work against tumor cells.

For more information on this trial from ClinicalTrials.gov, click here!

2014-0779

TitleA Phase 1b/2, Open-label Study to Evaluate the Safety and Tolerability of MEDI6469 in Combination with Immune Therapeutic Agents or Therapeutic Monoclonal Antibodies in Subjects with Selected Advanced Solid Tumors or Aggressive B-cell Lymphomas

DescriptionThis study is for patients with cancer that has not responded to or stopped responding to treatment with standard anticancer medicines or for which no standard therapy exists.

The main purpose of this study is to determine the best dose of MEDI6469 that is safe and tolerable when given alone and in combination with tremelimumab, MEDI4736, or rituximab in subjects with either advanced solid tumors or diffuse large B-cell lymphoma (DLBCL). Tremelimumab and MEDI4736 will be tested with MEDI6469 in a set of subjects with advanced solid tumors while rituximab will be tested with MEDI6469 in subjects with DLBCL.

All the study drugs are given intravenously (through a needle in a vein).

For more information on this trial from ClinicalTrials.gov, click here!

2015-0564

TitleA Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of MOXR0916 and MPDL3280A in Patients With Locally Advanced or Metastatic Solid Tumors

DescriptionThis study is for people who have cancer that has grown or spread and did not respond to previous treatment.

The purpose of this study is to find out whether two experimental drugs called MPDL3280A (also known as anti-PDL1 antibody) and MOXR0916 (also known as anti OX40 antibody) can be safely combined in patients with cancer. We want to find out what dose of MOXR0916 should be given with MDPL3280A and what effects the combination has on people with cancer. Both drugs are antibodies, which are a type of protein. The immune system makes antibodies in order to recognize substances that are foreign to the body such as viruses. MOXR0916 and MPDL3280A are antibodies that are made in a laboratory and designed to recognize OX40 and PD-L1 on human cells.

The body’s immune system has the ability to recognize and fight harmful infections and cancer. By blocking PD-L1 and OX40 these drugs may help the immune system to stop or reverse the growth of tumors and increase the ability of the the immune system to fight cancer better. 

Although both drugs have been tested in people with advanced cancer, the combination of MOXR0916 and MPDL3280A has not been used in people before. Both drugs are given as an intravenous (through a needle in a vein) infusion once every 3 weeks.

For more information on this trial from ClinicalTrials.gov, click here!

2015-0161

Title: A Phase 1B Study of PF-05082566 in Combination With Mogamulizumab (KW-0761) in Patients With Advanced Solid Tumors

DescriptionThis study is for patients with advanced cancer that is not responding to standard therapy or for which no standard therapy is available. 

The purpose of this study is to learn about the safety and effects of PF-05082566 on the body when it is given in combination with a second investigational drug called “mogamulizumab” or KW-0761. 

PF-05082566 is a new investigational drug that is an antibody (a type of protein), which has been shown to stimulate the immune system. It is thought that giving both drugs together may work better than giving only one drug by itself.

The study will try to find the safest dose of PF-05082566 that can be used with KW-0761 for treating solid tumor cancers. This study will also look at the way PF-05082566 and KW-0761 move through the body, and how the body breaks down these drugs. This is done by measuring the levels of each drug in the blood at different time points.

PF-05082566 will be given as a 1-hour intravenous (IV) infusion, once every 4 weeks. KW-0761 will be given as a 1-hour IV infusion once a week (for the first 4 weeks), and then once every two weeks.

For more information on this trial from ClinicalTrials.gov, click here!