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A phase I pilot stu...
A phase I pilot study of the insulin-like growth factor 1 receptor pathway modulator AXL1717 in combination with gemcitabine HCl and carboplatin in previously untreated, locally advanced, or metastatic non-small cell lung cancer
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- Holgersson, Georg (author)
- Uppsala universitet,Experimentell och klinisk onkologi,Centrum för klinisk forskning, Gävleborg
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- Bergström, Stefan (author)
- Uppsala universitet,Experimentell och klinisk onkologi
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Harmenberg, Johan (author)
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- Ringbom, Magnus (author)
- Uppsala universitet,Uppsala kliniska forskningscentrum (UCR)
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Klockare, Maria (author)
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Jerling, Markus (author)
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- Ekman, Simon (author)
- Uppsala universitet,Experimentell och klinisk onkologi
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- Lundström, Kristina Lamberg (author)
- Uppsala universitet,Institutionen för medicinska vetenskaper
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- Koyi, Hirsh (author)
- Karolinska Institutet
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Brandén, Eva (author)
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- Larsson, Olle (author)
- Karolinska Institutet
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- Bergqvist, Michael (author)
- Umeå universitet,Onkologi,Department of Oncology, Gävle Hospital, 801 87 Gävle, Sweden
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(creator_code:org_t)
- 2015-03-21
- 2015
- English.
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In: Medical Oncology. - : Springer Science and Business Media LLC. - 1357-0560 .- 1559-131X. ; 32:4
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
Subject headings
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- AXL1717 is an orally bioavailable IGF-1R pathway modulator that has been shown to have anti-tumoral effects. The objectives of the present study were to define maximum tolerated dose and the recommended phase II dose (RPTD) of AXL1717 in combination with gemcitabine HCl and carboplatin in non-small cell lung cancer (NSCLC). Patients with previously untreated, locally advanced, or metastatic NSCLC (squamous cell cancer or adenocarcinoma) in good performance status and with preserved major organ functions were enrolled in the study. The study was an open-label phase I study with planned cohorts of three patients per dose level of AXL1717 (215, 290, and 390 mg BID). In total, 12 patients were enrolled in the study, and of these, two were prematurely excluded. AXL1717 was administered at one dose level, 215 mg BID. A total number of 81 unique adverse events were reported. Bone marrow toxicity was reported in 10 out of 12 patients, and this organ class showed the largest number of related events. AXL1717 in combination with gemcitabine HCl and carboplatin is a possible treatment approach in previously untreated, locally advanced, or metastatic non-small cell lung cancer. However, due to the bone marrow toxicity profile shown in the present study, further dose increases of AXL1717 above 215 mg BID will probably not be feasible. Therefore, 215 mg BID constitutes maximum tolerated dose and RPTD.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Cancer and Oncology (hsv//eng)
Keyword
- Phase I
- IGF-1
- AXL1717
- Chemotherapy
- NSCLC
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Holgersson, Geor ...
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Bergström, Stefa ...
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Harmenberg, Joha ...
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Ringbom, Magnus
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Klockare, Maria
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Jerling, Markus
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Ekman, Simon
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Lundström, Krist ...
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Koyi, Hirsh
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Brandén, Eva
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Larsson, Olle
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Bergqvist, Micha ...
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Cancer and Oncol ...
- Articles in the publication
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Medical Oncology
- By the university
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Umeå University
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Uppsala University
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Karolinska Institutet