Weill Cornell Department of Medicine | Clinical Trials

An Open-Label, Multicenter, Phase 2 Study of Oral MLN9708 in Adult Patients with Relapsed and/or Refractory Follicular Lymphoma

2014-04-03T18:39:49Z

This clinical trial is for men and women with follicular lymphoma who have either relapsed after taking standard treatments or did not respond to (refractory to) standard treatments. The study is evaluating an experimental drug called MLN9708. The purpose of the study is to determine the effectiveness of MLN9708 in treating relapsed/refractory follicular lymphoma.

MLN9708 is capsule taken by mouth. It is a type of drug called a proteasome inhibitor. Proteasome inhibitors work by inhibiting proteins that cells need to survive and multiply. Cancer cells are more susceptible to this effect than normal cells. Inhibiting these proteins (proteasomes) may help kill cancer cells. All study participants will receive MLN9708; there is no placebo.

Treatment cycles are 28 days. Participants will take MLN9708 on Days 1, 8 and 15 of each cycle, followed by a rest period of 13 days.

Participants will continue to receive MLN9708 for as long as they are responding to therapy and not experiencing unacceptable side effects.

PCI-32765 (Ibrutinib) in Patients with Newly Diagnosed non-Germinal Center B-Cell subtype of Diffuse Large B-Cell Lymphoma

2014-04-03T18:04:46Z

This clinical trial is for men and women with newly diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) that is potentially of non-Germinal Center B-Cell (non-GCB) origin.

The study is evaluating the addition of the experimental drug ibrutinib (also known as PCI-32765) to standard chemotherapy to see if it is effective in treating people with non-GCB DLBCL who have not been previously treated.

Ibrutinib is an oral drug that inhibits the enzyme Bruton’s Tyrosine Kinase (BTK), decreasing the ability of lymphoma cells to grow and survive. R-CHOP (the combination of rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) is currently used as standard chemotherapy for newly diagnosed DLBCL.

Study participants will be randomly assigned to one of two treatment arms:

Arm A: R-CHOP + Ibrutinib
Arm B: R-CHOP + Placebo (a blank tablet that looks like ibrutinib but contains no medicine)

Study participants will receive 6 or 8 cycles of chemotherapy. Treatment cycles are 21 days. Participants will take ibrutinib/placebo once daily until the end of the chemotherapy cycles.

A Phase 2, Multi-center Study of High Dose Chemotherapy with Autologous Stem Cell Transplant followed by Maintenance Therapy with romidepsin for the Treatment of T-cell Non-Hodgkin Lymphoma (NHL)

2014-04-03T17:31:41Z

This clinical trial is for men and women with T-cell non-Hodgkin lymphoma. The purpose of the study is to test the benefit of a chemotherapy drug called romidepsin in men and women who have undergone autologous stem cell transplant.

Romidepsin has been FDA-approved for treating relapsed T-cell lymphoma. It is possible that in people in people who are at risk of their disease coming back (relapse), romidepsin could be used to prevent or delay the T-cell lymphoma from returning. The study will determine if giving romidepsin after the autologous stem cell transplant is safe and will prevent or delay the T-cell lymphoma from returning.

Participants will receive high dose chemotherapy followed by the stem cell transplant. Between 42 and 80 days after the transplant, participants will receive their first dose of romidepsin via infusion. Participants will continue to receive romidepsin every other week until 1 year after the stem cell transplant. If a participant’s disease has not progressed 1 year after the transplant, he/she will continue on romidepsin for another year.

A Phase I Study of the Safety, Pharmacokinetics and Pharmacodynamics of Escalating Doses of the Selective Inhibitor of Nuclear Export (SINE) KPT-330 in Patients with Advanced Hematological Malignancies

2014-04-03T17:04:31Z

This clinical trial is for men and women with relapsed/refractory advance hematological malignancies. The study is evaluating an experimental drug called KPT-330.

KPT-330 is a Selective Inhibitor of Nuclear Export (SINE) that irreversibly binds and inactivates CRM1, thereby forcing the nuclear retention of key tumor suppressor (TSP) and growth regulatory (GRP) proteins. Transient retention of TSP/GRP in the nucleus at high levels via CRM1 blockade activates their cell cycle checkpoint and genome surveying actions. This leads to the death of nearly all types of malignant cells, whereas normal cells undergo transient cell cycle arrest and recovery when the export block is released.

The purposes of this research study are to find out more information such as: the highest dose of KPT-330 that can be given safely, the side effects it may cause, to examine how the body affects the study drug concentrations in the blood (pharmacokinetics or PK), to examine the effects of this study drug on the body (pharmacodynamics or PDn) and to gain some information on its effectiveness in treating cancer.

Phase 1/2, Open-label, Dose Escalation Study of Vosaroxin in Patients with Intermediate 2 or High-risk Myelodysplastic Syndrome (MDS) after Failure of Hypomethylating Agent-based Therapy

2014-03-28T16:37:09Z

This clinical trial is for men and women with myelodysplastic syndrome (MDS) that is relapsed or refractory after treatment with a hypomethylating agent-based therapy.

The study is evaluating an experimental drug called vosaroxin, which is given as an IV infusion. The purpose of the study is to determine the safety and effectiveness of vosaroxin in treating relapsed/refractory high risk MDS.

The study is being done in two parts.

Part 1 (Dose Escalation Phase): this part of the study will look at the safety of increasing dose levels of vosaroxin in people with intermediate-2 or high-risk MDS. The dose determined to have the most effect without too many side effects will be used in Part 2.

Part 2 (Cohort Expansion Phase): participants in this part of the study will receive the dose that was determined to have the most effect in Part 1. Part 2 will evaluate how this dose of vosaroxin affects MDS.

The study is expected to last for about 5 years. A participant’s total length of time depends on how well he/she responds to therapy. Participants may continue on therapy as long as they are responding well to treatment and not experiencing unacceptable side effects.

A phase II randomized study of treatment-free remission in chronic myeloid leukemia-CP patients who achieve and sustain MR4.5 after switching to nilotinib

2014-03-28T16:12:11Z

This clinical trial is for men and women with chronic myeloid leukemia (CML) who have been treated with the drug imatinib for at least one year.

Participants in the study will receive the drug nilotinib (also called Tasigna) as their CML treatment. The purpose of the study is to evaluate the response rate 6 months after stopping nilotinib therapy in people who have achieved a very low level of leukemia cells in the blood, which is called “MR4.5.”

Nilotinib is approved by the FDA for treating CML.

Monitoring Phase

Study participants will switch from imatinib to nilotinib 300 mg twice daily for up to 2 years. Participants who achieve MR4.5 (low level of leukemia cells) will enter the Consolidation Phase.

Consolidation Phase

Study participants enter the Consolidation Phase as soon as MR4.5 is confirmed and will continue to be treated with nilotinib. Participants who sustain MR4.5 for 9 months will be randomly assigned to continue the Consolidation Phase for either 3 or 15 months. At the end of the Consolidation Phase, participants whose results show very low levels of leukemia cells (MR4.5 or below) may enter the Treatment-Free Remission Phase.

Treatment-Free Remission Phase

Participants will stop taking nilotinib and will be followed closely. If blood tests show that the amount of leukemia cells has increased, participants will re-start taking nilotinib.

Treatment Re-Initiation

Participants who re-start nilotinib will be monitored for 3 years from the start of the treatment-free phase.

Phase II Randomized, Double-Blinded, Placebo-Controlled Study of Pracinostat in Combination w/ Azacitidine in Patients w/ Previously Untreated International Prognostic Scoring System (IPSS) Intermediate Risk 2 or High Risk Myelodysplastic Syndrome (MDS)

2014-03-28T15:50:47Z

This clinical trial is for men and women with previously untreated myelodysplastic syndrome (MDS).

The study is evaluating a new experimental drug called pracinostat as an addition to standard MDS treatment, azacitidine. The study is testing the safety and effectiveness of pracinostat when combined with azacitidine, compared to azacitidine alone.

Pracinostat is a pill taken by mouth. It has been shown in the laboratory to kill cancer cells, and animal studies show that pracinostat is active against many cancer cell types. Azacitidine is FDA-approved treatment for MDS. It is given by injections under the skin or by infusion to a vein.

Study participants will be randomly assigned to one of two treatment arms:

Arm 1: azacitidine + pracinostat
Arm 2: azacitidine + placebo (a pill that looks like pracinostat but contains no medicine)

Treatment Plan:

Treatment cycles are 28 days
Participants will take pracinostat/placebo 3 times a week for 3 weeks, followed by 1 week of rest in each treatment cycle
Participants will receive azacitidine via injection or infusion for 7 days of each treatment cycle

Participants will continue treatment as long as they are responding and not experiencing unacceptable side effects.

Phase IIIB, Open-label, Multi-Center Study of the Efficacy and Safety of Rigosertib Administered as 72-hour Continuous Intravenous Infusions in Patients with Myelodysplastic Syndrome with Excess Blasts Progressing On or After Azacitidine or Decitabine

2014-03-28T15:29:52Z

This clinical trial is for men and women with myelodysplastic syndrome (MDS) who relapsed after taking azacitidine or decitabine.

The study is evaluating an experimental drug called rigosertib. The purpose of the study is to determine the effectiveness of rigosertib in treating MDS. Although the way rigosertib works is not fully known, it is thought to kill cancer cells by stopping tumor cells from dividing and growing, and by blocking the proteins involved in cell division, causing cancer cells to die.

Study participants will receive rigosertib via infusion over 72 consecutive hours (3 days) once every other week for the first 16 weeks, and then once every 4 weeks.

Participants will continue to receive rigosertib for as long as they are responding to therapy and not experiencing unacceptable side effects.

Phase 1/2, Open-label, Dose-escalation, Multi-ctr Study to Assess Safety, Tolerability, PK, & PD of Oral NS-018 in Patients w/ Primary Myelofibrosis, Post polycythemia Vera Myelofibrosis, or Post-essential Thrombocythemia Myelofibrosis

2014-03-27T18:59:01Z

This clinical trial is for men and women with myelofibrosis. The study is evaluating a new, experimental drug called NS-018 to treat myelofibrosis. NS-018 is in a group of drugs called Janus kinase 2 (JAK2) inhibitors, which have shown promise in easing the symptoms of myelofibrosis. NS-018 is a tablet taken by mouth.

This study includes a Phase I portion and a Phase II portion.

Phase I

The purpose of Phase I is to evaluate the safety and tolerability of NS-018 and to determine the appropriate dose of the drug to be used in further studies. As different groups of people enroll in the Phase I study, they will receive higher doses of NS-018 until the appropriate dose is determined. Therefore the dose you receive in Phase I will depend on when you enroll in the study.

Phase II

Participants in Phase II will receive NS-018 at the dose (or doses) determined in Phase I as the appropriate dose. The purpose of Phase II is to further evaluate the safety and effectiveness of NS-108 in treating myelofibrosis.

All study participants in Phases I and II will receive NS-018 taken daily; there is no placebo. Participants may continue on NS-108 treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

A Phase 1, Multicenter, Open-Label, Dose-Escalation, Safety, Pharmacokinetic, Pharmacodynamic, and Clinical Activity Study of Orally Administered AG-221 in Subjects with Advanced Hematologic Malignancies with an IDH2 Mutation

2014-03-27T15:48:02Z

This clinical trial is for men and women with advanced hematologic malignancies. The study is evaluating an experimental drug called AG-221.

IDH2 is a type of protein involved in providing the body's cells with energy or metabolism. In certain types of diseases, like AML and MDS, an abnormal form of IDH2 is present in the diseased cells. When this happens, it produces an excess amount of 2-HG, a substance normally present in cells in low levels. Excessive amounts of 2-HG may prevent cells from maturing into normally functioning cells and may cause them to become diseased.

AG-221 may stop the abnormal IDH2 protein and may reduce 2-HG levels in diseased cells so that they can become normal cells. The purpose of this study is to identify and study the highest dose of AG-221 that can be given safely and to determine the effects the drug has on hematologic cancers. AG-221 is a tablet taken by mouth.

The study has 2 parts (participants will only be enrolled in 1 part).

In Part 1, different groups of participants will receive increasing dose levels of AG-221 to find the dose that has the most effect while still being tolerated by participants. Part 2 will study how the maximum tolerated dose (determined in Part 1) affects the cancer.

Participants will take AG-221 twice daily on every day of 28 day cycles. Participants will continue on study treatment for as long as they are responding to therapy and not experiencing unacceptable side effects.

Multicenter, Double-blind, Randomized, Parallel-group, Pilot Study of 12-week Duration to Assess Short-term Safety and Tolerability of Lorcaserin + Two Doses of Immediate-Release Phentermine-HCl Compared w/ Lorcaserin Alone in Overweight & Obese Adults

2014-03-13T20:15:28Z

This clinical trial is for men and women who are obese or overweight. The study is evaluating the combination of two drugs for weight reduction. The drugs are called Belviq (also called lorcaserin HCL) and phentermine hydrochloride (phentermine HCL). The purpose of the study is to determine the safety and effectiveness of Belviq in combination with two different doses of phentermine HCL.

Belviq is a tablet and is FDA-approved as an addition to a reduced-calorie diet and exercise for chronic weight management. Phentermine HCL is a capsule and is FDA-approved for short-term addition in a weight reduction plan. The combination of the drugs, however, is not approved and is therefore considered experimental.

Study participants will be randomly assigned to one of three treatment arms:

· Arm A: Belviq + Phentermine Placebo

o Belviq twice daily + Phentermine placebo twice daily

· Arm B: Belviq + Phentermine–HCL + Phentermine placebo

o Belviq twice daily + Phentermine-HCL once daily + Phentermine placebo once daily

· Arm C: Belviq + Phentermine-HCL

o Belviq twice daily + Phentermine-HCL twice daily

A placebo is a blank capsule that looks like phentermine but contains no medicine. Neither participants nor the study physician and staff will know whether they are receiving active drug phentermine or placebo. All study participants will receive Belviq. Participants will receive diet and exercise counseling at 6 study visits.

Participants will be on study treatment for 12 weeks and have a follow-up visit 4 weeks after stopping treatment.

A Randomized, Phase 2, Open-Label Study Evaluating DN24-02 as Adjuvant Therapy in Subjects with High Risk HER2+ Urothelial Carcinoma

2013-11-19T21:50:18Z

This is a clinical trial for men and women with urothelial cancer (cancer of the bladder, renal pelvis, urethra or ureter) who have had surgery to remove the cancer and have a high risk of the cancer returning.

The study is evaluating an experimental drug called DN24-02 for urothelial cancer. DN24-02 uses cells, called antigen presenting cells, which are prepared from a person’s own blood. An antigen is a protein which may be able to stimulate the body’s immune system. Antigen presenting cells are a type of white blood cells that fight cancers and infections; they teach other white blood cells to recognize specific markers on other cells in the body. Training the white blood cells to recognize markers may help the immune system find and attack cancer cells.

This study compares people who receive DN24-02 to people who do not receive DN24-02. The purpose of the study is to determine if DN24-02 helps people with urothelial cancer live longer. The study will also assess the safety of DN24-02 and whether it delays the time until urothelial cancer returns.

Study participants will be randomly assigned to either:

receive DN24-02, or
not receive DN24-02, and be monitored by the study physician by physical exam, routine blood tests and immune monitoring (standard of care)

Participants assigned to receive DN24-02 will have blood cells removed from their body by leukapheresis. The white blood cells will be used to make an individual participant’s dose of DN24-02, and participants will receive DN24-02 via infusion. The same procedures will be repeated about 2 weeks and 4 weeks after the first infusion.

GO27983: A Phase Ib/II Study of GDC-0068 or GDC-0980 with Abiraterone Acetate versus Abiraterone Acetate in Patients with Castration-Resistant Prostate Cancer Previously Treated with Docetaxel-Based Chemotherapy

2013-11-19T21:25:35Z

This clinical trial is for men with prostate cancer whose disease worsened while receiving or after receiving treatment with docetaxel.

The purpose of the study is to determine the safety and tolerability of two experimental drugs, GDC-0068 and GDC-0980, when either one is given in combination with the drugs abiraterone and prednisone. The study will also evaluate whether giving GDC-0068 or GDC-0980 with abiraterone improves the efficacy of abiraterone in treating castration-resistant prostate cancer (CRPC).

GDC-0068 is designed to block a protein called Akt, which is thought to be important in cancer. GDC-0980 inhibits a protein called P13-kinase that may be involved in the growth and spread of some cancers. In laboratory experiments, GDC-0068 and GDC-0980 have been shown to prevent or slow the growth of many different types of cancer cells. Abiraterone is FDA-approved for the treatment of CRPC.

Participants at Weill Cornell will participate in the Phase II portion of the study and will be randomly assigned to one of three treatment arms:

Arm A: abiraterone/prednisone in combination with GDC-0068
Arm B: abiraterone/prednisone in combination with GDC-0980
Arm C: abiraterone/prednisone in combination with a placebo (an inactive substance that contains no medicine)

All participants will receive abiraterone, the FDA-approved treatment in combination with prednisone. Abiraterone, prednisone, GDC-0068 and GDC- 0980 are taken by mouth.

Study participants will continue treatment until their cancer worsens or they experience side effects that cannot be tolerated.

A Double-blind, Placebo-controlled Study to Evaluate New or Worsening Lens Opacifications in Subjects with Non-metastatic Prostate Cancer Receiving Denosumab for Bone Loss due to Androgen-Deprivation Therapy

2013-11-19T21:05:24Z

This is a clinical trial for patients with prostate cancer who are receiving androgen deprivation therapy for the prostate cancer. Treatment of prostate cancer is often initially targeted at removal and/or radiation of the tumor and preventing the spread of tumor cells. Another common treatment is called androgen deprivation therapy (ADT), which is a type of hormone therapy where the body is deprived of androgen that feeds the prostate cancer. However, ADT is also an important cause of osteoporosis (thinning of bones)—loss of bone mass and increased risk of fractures.

Denosumab is a novel protein that has been shown in clinical trials to regulate bone metabolism by inhibiting the cells that break down bone. This results in a slower rate that bone is broken down and an increase in bone mass. In an earlier study denosumab was shown to be well tolerated and to have an overall safety profile similar to the placebo.

However, the number of patients with cataracts (clouding of the lens in the eye) was higher in the group of patients who received denosumab compared to the group of patients who received placebo. Since there was a difference in the number of cataracts compared to placebo, we would like to further study this.

The purpose of this current study is to evaluate if there is a difference between denosumab and placebo in changes in patients’ eyes and the lenses in their eyes. These differences will be evaluated using eye examinations that ophthalmologists use in evaluating changes to the eyes

Study participants will be randomly assigned to 1 of 2 study groups:

Group 1: 60 mg of denosumab subcutaneous (under the skin) injection at Day 1 and Month 6
Group 2: 60 mg of placebo (looks like denosumab but contains no medicine) injection on Day 1 and Month 6

Neither you nor the study physician will know whether you are receiving denosumab or placebo. Patients will also take daily supplements of Vitamin D and calcium. The expected time on study is about 13 months.

A Phase 2, Open-label, Multicenter Study of PSMA ADC in Subjects with Metastatic Castration-resistant Prostate Cancer (mCRPC)

2013-11-15T20:41:32Z

This clinical trial is for men with metastatic castration-resistant prostate cancer (mCRPC). The purpose of the study is to evaluate the anti-tumor activity and safety of an experimental drug called PSMA ADC. The study will also evaluate how well men with mCRPC tolerate the drug.

PSMA ADC belongs to a class of medicines called antibody-drug conjugates. PSMA ADC is made up of three parts: an antibody; a drug that kills cancer cells; and a linker that holds to the first two parts together. The antibody in PSMA ADC recognizes a protein on the surface of prostate cancer cells, called “prostate-specific membrane antigen (PSMA),” and binds to it. Once bound, PSMA ADC enters the prostate cancer cell, and the cancer-killing drug portion is released into the cancer cells.

All study participants will receive PSMA ADC, which is administered via infusion. There is no placebo in this study. Participants will receive PSMA ADC every three weeks for up to eight doses.