No Placebo-Only Group

The purpose of this Phase I, multicenter study is to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical activity of AG-120 in advanced hematologic malignancies that harbor an IDH1 mutation. The first portion of the study is a dose escalation phase where cohorts of patients will receive ascending oral doses of AG-120 to determine maximum tolerated dose (MTD) and/or the recommended Phase II dose. The second portion of the study is a dose expansion phase where four cohorts of patients will receive AG-120 to further evaluate the safety, tolerability, and clinical activity of the recommended Phase II dose. Additionally, the study includes a substudy evaluating the safety and tolerability, clinical activity, pharmacokinetics, and pharmacodynamics of AG-120 in subjects with relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.

Study of Orally Administered AG-120 in Subjects With Advanced Hematologic Malignancies With an IDH1 Mutation

AG-120 for Blood Cancers

This study is evaluating whether AG-120 may be effective in treating blood cancers.

I haven't had cancer treatment or radiotherapy in the last 14 days, except for hydroxyurea.

I do not have a severe infection or unexplained fever over 38.5°C.

I have severe heart failure or my heart's pumping ability is less than 40%.

I have a history of severe heart rhythm problems.

My platelet count is at least 20,000/µL, transfusions included.

My blood cancer has a specific IDH1 R132 gene mutation.

I am willing to undergo repeated bone marrow biopsies, blood, and urine tests.

I had a heart attack in the last 6 months.

I have unstable or uncontrolled chest pain.

I am a woman who can have children and have a recent negative pregnancy test.

I am taking medication that affects my heart's rhythm.

I do not have HIV or active hepatitis B or C.

I might have leukemia in my brain or spinal cord.

I am experiencing severe, life-threatening complications from leukemia.

I can take care of myself and am up and about more than half of my waking hours.

My liver functions, including AST, ALT, and ALP levels, are within normal limits.

My kidney function is within the required range.

I have recovered from side effects of my previous cancer treatments.

I had a stem cell transplant less than 60 days ago, or I am on immunosuppressants, or I have significant GVHD.

My heart's electrical activity (QTc interval) is normal or I don't have factors that risk abnormal heart rhythms.

AG-120

The primary hypothesis of this study is that outcomes for patients with biochemically recurrent prostate cancer following radical prostatectomy will be improved by the addition of enzalutamide for 6-months compared to standard-of-care salvage radiation therapy to allow for further study in the definitive phase III setting. This study builds on the prior success of high-dose bicalutamide (for 24 months) when combined with salvage external radiation therapy (XRT), while using a newer more potent anti-androgen for a shorter duration of time (6 months) in an effort to minimize adverse effects.

Randomized Salvage Radiation Therapy Plus Enzalutamide Post Prostatectomy

Enzalutamide + SRT for Prostate Cancer

This study is evaluating whether a new drug called enzalutamide can improve outcomes for men with prostate cancer who have had surgery.

My prostate cancer has returned, shown by rising PSA levels after surgery.

My testosterone levels are not low and within the study's required range.

I do not have serious heart issues, seizures, or conditions that could cause seizures.

My cancer is adenocarcinoma of the prostate.

My cancer has not spread to other parts of my body, confirmed by recent scans.

I do not have serious illnesses like heart, lung, severe liver conditions, or major infections.

My cancer had not spread to my lymph nodes at the time of surgery.

I will use a condom during sex with a pregnant partner during the study.

I have not had hormone therapy for my condition, except possibly with surgery.

I am using two forms of birth control, including condoms, during and 3 months after the study.

I am mostly active and my doctor expects me to live more than 3 years.

My main cancer treatment is radiation therapy.

I am not using any other cancer treatments.

I have been cancer-free for over 3 years, except for non-melanoma skin cancer or superficial bladder cancer.

I am not taking steroid pills, but I can use inhalers.

I am not taking any other antiandrogens, estrogen-like agents, or 5a-reductase inhibitors.

My cancer has come back in the area where it was first found.

I had surgery to remove my prostate as the first treatment.

I have another type of cancer that is currently active.

Enzalutamide

Salvage Radiation Therapy

This is an open-label, multicenter, global Phase 2 basket study of entrectinib (RXDX-101) for the treatment of patients with solid tumors that harbor an NTRK1/2/3, ROS1, or ALK gene fusion. Patients will be assigned to different baskets according to tumor type and gene fusion.

Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions)

Entrectinib for Solid Tumors

This study is evaluating whether a drug may help treat tumors with certain gene fusions.

I have been treated with specific inhibitors for my cancer due to certain gene changes.

My cancer can be measured or seen on tests.

I finished my radiotherapy more than 14 days ago.

My cancer is advanced and tests positive for specific genetic changes.

I have a family or personal history of bone disorders.

I am still recovering from a recent surgery.

I have had heart failure symptoms or a low heart pump function in the last 3 months.

I have a history of long QT intervals not caused by medication.

I have risk factors for irregular heartbeats.

My brain involvement from cancer is either symptom-free or was treated and is now under control.

I have lung scarring or inflammation from previous treatments.

I have moderate to severe numbness, tingling, or pain in my hands or feet.

I have a condition that affects my stomach or intestines' ability to absorb nutrients.

I can provide a tissue sample for testing unless it's medically unsafe for me.

I have had cancer treatment but not with Trk, ROS1, or ALK inhibitors for specific gene changes.

It's been over 2 weeks since my last cancer treatment.

It has been over 4 weeks since my last antibody therapy.

I can care for myself and doctors expect me to live at least another month.

I have no other cancers that would affect this trial's results.

Entrectinib

Pivotal Trial

The primary purpose of the study is to demonstrate that lenvatinib in combination with everolimus (Arm A) or pembrolizumab (Arm B) is superior compared to sunitinib alone (Arm C) in improving progression-free survival (PFS) (by independent imaging review [IIR] using Response Evaluation Criteria in Solid Tumors [RECIST 1.1]) as first-line treatment in participants with advanced renal cell carcinoma (RCC).

Lenvatinib/Everolimus or Lenvatinib/Pembrolizumab Versus Sunitinib Alone as Treatment of Advanced Renal Cell Carcinoma

Combination Therapy vs Standard Treatment for Kidney Cancer

This study is evaluating whether a combination of lenvatinib and everolimus is more effective than sunitinib.

I have had pneumonitis treated with steroids or have it now.

I am a male who hasn't had a vasectomy and agree to use a condom and spermicide.

My kidney cancer is in an advanced stage.

Your heart takes too long to recharge between beats.

You have high levels of protein in your urine.

Your cholesterol or triglyceride levels are too high when you haven't eaten for a while.

Your diabetes is not well controlled, as shown by a high fasting glucose level.

You currently have a disease where your immune system attacks your own body.

You have at least one specific type of tumor that can be measured and meets certain criteria.

I have had cancer within the last 2 years.

I have not had radiation therapy in the last 21 days.

I haven't taken any experimental drugs in the last 4 weeks.

I still have side effects from recent major surgery.

I have not had significant coughing up of blood or tumor bleeding in the last 2 weeks.

I have an immune system disorder or am on long-term steroids.

My kidney cancer diagnosis includes a clear-cell type.

I have a condition that affects how my body absorbs medication.

I have a bleeding or clotting disorder, or I'm at high risk for severe bleeding.

I am able to care for myself but may not be able to do active work.

I have an active Hepatitis B or C infection.

My cancer has spread to my brain or spinal cord.

I am a woman able to have children and do not agree to use effective birth control.

I have received an organ or tissue transplant from another person.

I have not taken any drugs for kidney cancer that target blood vessel growth.

I have a history of lung disease involving the tissue and space around the air sacs.

I have not received a live vaccine in the last 30 days.

I have not had major heart problems in the last year.

My blood pressure is under control, with or without medication.

Everolimus

Lenvatinib

Pembrolizumab

Sunitinib

This is a Phase I/II, open-label, multi-center, multi-national, dose escalation, single agent study to assess the safety, tolerability, PK, PD, immunogenicity and anti-tumor activity of zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion (eNRGy)

A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)

Zenocutuzumab for Solid Tumors

This study is evaluating whether a drug may help treat cancer.

Your liver enzyme levels and bilirubin levels should be within certain limits. If you have liver spread of cancer, slightly higher levels are allowed. If you have Gilbert's syndrome, higher bilirubin levels are allowed.

I can provide a new or old sample of my tumor for testing.

You are expected to live for at least 12 more weeks.

I have HIV or untreated Hepatitis B, or I've been treated for Hepatitis C with no detectable virus now.

I have brain metastases that are causing symptoms or are unstable.

I have a fever or infection that isn't under control.

I have heart issues like heart failure, low heart pump function, or serious heart rhythm problems.

I had cancer before, but it was treated over 2 years ago.

I have at least one tumor that can be measured or my disease can be evaluated in another specific way.

I have recovered from major surgery with minimal side effects.

My white blood cell count is healthy without needing medication for the past week.

I am able to care for myself and perform daily activities.

I will use birth control during and for 6 months after the study.

I haven't taken any cancer drugs or experimental medications recently.

My platelet count is healthy without needing a transfusion in the last week.

My cancer is advanced, cannot be surgically removed, and has an NRG1 gene fusion.

Your doctor thinks you will live for at least 12 more weeks.

Your kidney function is good, with a GFR of more than 30 mL/min.

My cancer has spread to the lining of my brain and spinal cord.

You are allergic to any of the ingredients in MCLA-128.

Side effects from my previous cancer treatments are mild.

I have undergone or am considered unsuitable for standard cancer treatments.

Your hemoglobin level needs to be at least 8 g/dL or 5 mmol/L.

Zenocutuzumab (MCLA-128)

All Individual Drugs Already Approved

Approved for 30 Other Conditions

This is a biomarker preselected, randomized, open-label, multicenter, phase II study in men with metastatic castration resistant prostate cancer (mCRPC). Patients with tumors that have ATM, BRCA1 and/or BRCA2 mutations/deletions/loss of heterozygosity will be randomized in a 1:1:1 fashion to each arm. Patients with mutations in noncanonical DNA repair genes including FANCA, PALB2, RAD51, ERCC3, MRE11, NBN, MLH3, CDK12, CHEK2, HDAC2, ATR, PMS2, GEN1, MSH2, MSH6, BRIP1, or FAM175A defects will be assigned to Arm IV with single agent olaparib.

Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects

Abiraterone + Prednisone/Olaparib for Prostate Cancer

This study is evaluating whether a drug may help treat prostate cancer.

I have stopped taking all strong medications that affect liver enzymes.

I am allergic to medications similar to olaparib or abiraterone.

I am HIV-positive and on antiretroviral therapy, which may interact with the treatment.

I have had a seizure or multiple seizures in the past 2 years.

I have a specific DNA repair defect and severe disease in my organs or bones needing quick treatment.

I can take care of myself and am up and about more than half of the day.

I can take a daily Multi-Vitamin, calcium, and Vitamin D but must stop all other supplements and hormonal treatments before starting the trial.

I have taken ketoconazole for prostate cancer but not other CYP17 or PARP inhibitors.

I haven't taken itraconazole, ketoconazole, or fluconazole in the last 3 weeks.

I do not have a history of pituitary or adrenal problems, nor do I have active hepatitis or chronic liver disease.

I have long-term blood-related issues, including bone marrow problems.

I stopped taking certain medications like phenytoin and St John's Wort 3 weeks ago.

I stopped taking phenobarbital 5 weeks ago.

I agree to a biopsy to check for DNA repair defects in my cancer.

I agree to use contraception during and for 3 months after the study.

I stopped taking hormone therapy for cancer 4 weeks ago and my PSA levels haven't dropped.

My testosterone levels are below 50 ng/dL, and I am on hormone therapy unless I've had orchiectomy.

I have recovered from any surgery or radiation therapy side effects.

I've had chemotherapy for hormone-resistant cancer, but stopped at least 4 weeks ago.

I have moderate to severe liver problems.

I have been diagnosed with prostate adenocarcinoma, not small-cell carcinoma.

I have not had major surgery in the last 2 weeks or have fully recovered from it.

I have a serious health condition that is not under control.

I have not had a blood transfusion in the last 30 days.

I stopped taking certain medications like ritonavir a week ago.

My organs are functioning well, as tested within the last 14 days.

I have a history of serious heart problems.

I haven't taken any forbidden medications in the last week.

I am willing and able to follow the study's treatment plan and attend all visits.

I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

I have another active cancer besides non-dangerous skin cancer or superficial bladder cancer.

I am not planning to undergo chemotherapy, surgery, or radiation while on the trial treatment.

I can swallow pills without needing to break them down.

I have lasting side effects from cancer treatment, but not hair loss.

I have had a bone marrow transplant from another person.

You have advanced prostate cancer that is getting worse according to specific criteria.

Maha Hussain, MD, FACP, FASCO

Abiraterone Acetate

Olaparib

Prednisone

Approved for 10 Other Conditions

This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.

Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

Crenolanib + Chemotherapy for Acute Myeloid Leukemia

This study is evaluating whether a drug may help treat acute myeloid leukemia.

I have never been treated with crenolanib or been in a crenolanib study.

My AML did not respond or has returned after initial treatments.

I have been diagnosed with AML according to WHO standards.

I have active leukemia in my brain or spinal cord.

I have an active hepatitis B or C infection.

I haven't had leukemia treatment in the last 14 days, except for hydroxyurea.

My cancer has a specific genetic mutation (FLT3-ITD or D835).

Crenolanib

This study is an open label, multicenter, randomized phase II trial of consolidation immunotherapy with either nivolumab alone or the combination of nivolumab and ipilimumab following concurrent chemoradiation in patients with unresectable stage III NSCLC.

Unresectable Stage IIIA/IIIB Non-small Cell Lung Cancer (NSCLC)

Immunotherapy for Lung Cancer

This study is evaluating whether a combination of two immunotherapy drugs may help treat lung cancer.

Karmanos Cancer Center Clinical Trials 2022

Trials at this site