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Study description
The study was done to test a new cancer drug called AG-270 (also called S95033) in participants with advanced solid tumors or lymphomas.
Cancers fall into two categories: solid tumor cancers and blood cancers.
Solid tumor cancers are abnormal growths of cells in organ(s) of the body such as the lung, breast, or pancreas. In advanced stages of disease, solid tumors may spread in the body.
Blood cancers affects blood cells in the body. Lymphoma is a type of blood cancer.
AG-270 was tested in patients whose cancer had lost a protein called methylthioadenosine phosphorylase (MTAP). In this type of cancer, it is believed that AG-270 will be potentially helpful as an alternative treatment. Indeed, AG-270 works by decreasing levels of a substance called S-adenosylmethionine (SAM). In laboratory experiments, reducing the levels of SAM in cancer cells with MTAP loss slows their growth.
In this study, AG-270 was combined with other drugs that block the growth of cancer cells. The drugs are called docetaxel, nab-paclitaxel, and gemcitabine. These drugs are marketed and used in several countries for cancer treatment.
The main goal of this study was to find the highest dose of AG-270 that participants could take without too much risk (highest tolerated dose) when given:
- Alone (treatment 1).
- In combination with docetaxel (treatment 2).
- In combination with nab-paclitaxel and gemcitabine (treatment 3).
English (USA)
Français (France)
Español (España)- AG-270
- docetaxel
- nab-paclitaxel
- gemcitabine
- AG270-C-001
Eligibility Criteria
Eligible age for the study
Sex
Male/FemaleAccepts Healthy Volunteers
NoTo take part, participants had to:
- Be at least 18 years of age.
- Have advanced cancer with MTAP loss.
- For treatment 1:
- Have solid tumor or lymphoma that worsened despite treatment, and with no other standard treatment available.
- For treatment 2:
- Have a specific type of lung cancer called non-small cell lung cancer, or have another type of solid tumor cancer if doctor considers docetaxel a standard option for its treatment.
- For treatment 3:
- Have cancer in the pancreas (the organ lying behind the lower part of the stomach).
Participants could not take part in the study if they:
- Had a primary brain cancer. Primary cancer means that the cancer started in the brain, rather than spreading from other parts of the body.
- Had cancer that has spread to the brain and was causing symptoms or needed treatment with steroids or certain medicines.
How is the study designed?
Participants received AG-270 tablets taken orally at doses from 50 milligrams (mg) to 400 mg once daily or 200 mg twice daily, every day of each cycle.
Participants received AG-270 tablets taken orally at doses of 100 mg, 150 mg, or 200 mg once daily for the first week. From the second week, along with AG-270 daily tablets they also received docetaxel through an infusion (an injection given slowly into a vein), every 21 days, at a dose of 75 mg per square meter (m²) of body surface area (75 mg/m²) or 55 mg/m² depending on the tolerability.
Participants received AG-270 tablets taken orally at doses of 100 mg, 150 mg, or 200 mg once daily for the first week. From the second week, along with AG-270 daily tablets they also received nab-paclitaxel at a dose of 100 mg/m² or 125 mg/m² and gemcitabine at a dose of 800 mg/m² or 1000 mg/m², depending on the tolerability, given through infusions. Infusions were given on Days 1, 8, and 15 of each cycle.