Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Derazantinib low dose range · 1 trial · 1 indication
Adverse events were graded for severity according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. CTCAE is classifying AEs and their associated severity from Grade 1 (Mild AE), Grade 2 (Moderate AE), Grade 3 (Severe or medically significant but not immediately life-threatening), Grade 4 (Life-threatening consequences) to Grade 5 (Death related to AE)
| Arm | Type | Description |
|---|---|---|
| Low Dose Group | EXPERIMENTAL | Patients who received derazantinib orally at dose levels from 25 mg every other day (QOD) - 200 mg daily (QD) on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria. |
| Middle Dose Group | EXPERIMENTAL | Patients who received derazantinib orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria. |
| High Dose Group | EXPERIMENTAL | Patients who received derazantinib orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria. |
| Expanded Cohort Group | EXPERIMENTAL | Patients who received derazantinib orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule until documented progression of disease (clinical or radiological), unacceptable toxicity, or another of the discontinuation criteria. |
| Name | Type | Description |
|---|---|---|
| Derazantinib low dose range | DRUG | Derazantinib was administered orally at dose levels from 25 mg QOD - 200 mg QD on a 28-day schedule. |
| Derazantinib middle dose range | DRUG | Derazantinib was administered orally at dose levels from 250 mg QD - 325 mg QD on a 28-day schedule. |
| Derazantinib high dose range | DRUG | Derazantinib was administered orally at dose levels from 400 mg QD - 425 mg QD on a 28-day schedule. |
| Derazantinib at recommended phase 2 dose (RP2D) | DRUG | Derazantinib was administered orally at the recommended phase 2 dose of 300 mg QD on a 28-day schedule. |
Inclusion Criteria: 1. Signed written informed consent granted 2. Men or women ≥18 years of age 3. Histologically or cytologically confirmed, locally advanced, inoperable, or metastatic solid tumors. Patients eligible for enrollment in the Expanded Cohort must have documented and/or confirmed FGFR ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 2 | PHASE2 | pembrolizumab |
| Incyte Corporation | INCY | 1 | PHASE2 | Chemotherapy, Retifanlimab |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | E7 TCR-T cells, Aldesleukin |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115, pembrolizumab |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
Derazantinib low dose range is an investigational small molecule being studied for the treatment of solid tumors. It is a targeted therapy that is being evaluated in patients with advanced solid tumors that have FGFR genetic alterations. The drug is currently in clinical development and has not been approved by regulatory authorities.
Derazantinib low dose range targets FGFR genetic alterations. It is designed to act on tumors that harbor these specific genetic changes, which are found in certain solid tumors. The drug is being studied in a biomarker-selected patient population to assess its potential efficacy in this molecularly defined subset of cancer patients.
Derazantinib low dose range is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The company is conducting clinical research to evaluate the safety and efficacy of this investigational drug in patients with advanced solid tumors.
Derazantinib low dose range is in Phase 1 clinical development. It is an investigational drug that has not yet received regulatory approval. The Phase 1 trial has been completed, and the drug is no longer in active clinical testing according to the available trial data.
Derazantinib low dose range was studied in a Phase 1/2 clinical trial with the identifier NCT01752920. This trial was a controlled, non-randomized, open-label study that enrolled 119 adult patients with advanced solid tumors and FGFR genetic alterations. The trial was conducted in the United States and Italy and has been completed.
Yes, Derazantinib low dose range is also known as ARQ 087. The clinical trial NCT01752920, which studied this drug, was titled 'Phase 1/2 Study of Derazantinib (ARQ 087) in Adult Subjects With Advanced Solid Tumors With FGFR Genetic Alterations.' This confirms that both names refer to the same investigational drug.