A Phase I Trial and Pharmacokinetic Study of Tipifarnib, a Farnesyltransferase Inhibitor, and Tamoxifen in Metastatic Breast Cancer
Purpose: Farnesyltransferase (FTase) inhibitors, which were designed to inhibit oncogenic Ras, act synergistically with tamoxifen in preclinical breast cancer models. We studied the safety and toxicity of tipifarnib in combination with tamoxifen in metastatic breast cancer. The pharmacokinetics and...
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| Veröffentlicht in: | Clinical cancer research 2005-02, Vol.11 (3), p.1247-1252 |
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| creator | LEBOWITZ, Peter F ENG-WONG, Jennifer WIDEMANN, Brigitte C BALIS, Frank M JAYAPRAKASH, Nalini CHOW, Catherine CLARK, Geoff GANTZ, Susan B VENZON, David ZUJEWSKIL, Joanne |
| description | Purpose: Farnesyltransferase (FTase) inhibitors, which were designed to inhibit oncogenic Ras, act synergistically with tamoxifen
in preclinical breast cancer models. We studied the safety and toxicity of tipifarnib in combination with tamoxifen in metastatic
breast cancer. The pharmacokinetics and pharmacodynamics of tipifarnib were also assessed.
Patients and Methods: Patients with metastatic, hormone receptor–positive breast cancer were enrolled. Two cohorts of patients were treated with
tipifarnib at either 200 or 300 mg p.o. twice daily for 21 of 28 days. Tamoxifen (20 mg once daily) was started after 1 week
of tipifarnib monotherapy to perform pharmacokinetics and FTase inhibition levels in peripheral blood mononuclear cells with
tipifarnib alone and with tipifarnib and tamoxifen.
Results: A total of 12 heavily pretreated patients with prior progression on hormonal therapy were enrolled. Minimal toxicity was
observed at the 200-mg dose level of tipifarnib. At the 300-mg dose, all six patients required dose reduction of tipifarnib
due to toxicities that included grade 2 nausea, rash, and fatigue and grade 3 diarrhea and neutropenia. Tipifarnib pharmacokinetic
and pharmacodynamic variables were similar in the presence and absence of tamoxifen. Average FTase inhibition was 42% at 200
mg and 54% at 300 mg in peripheral blood mononuclear cells. Of the 12 patients treated, there were two partial responses and
one stable disease for >6 months.
Conclusions: Tipifarnib (200 mg twice daily for 21 of 28 days) and tamoxifen (20 mg once daily) can be given safely with minimal toxicity.
Tamoxifen does not have a significant effect on tipifarnib pharmacokinetics. |
| doi_str_mv | 10.1158/1078-0432.1247.11.3 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_21270277</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>21270277</sourcerecordid><originalsourceid>FETCH-LOGICAL-c442t-f256c2fa6d8b8c1d33a388266a06dc787d270fa0b2b74e74ad2e61b1d0c26bc93</originalsourceid><addsrcrecordid>eNpFkE2LFDEQhoMo7of-AkFyUfawPeark57jOri6sKLgeA7V6Yod7Y_ZpAeds3_cdM_InuqleOoteAh5xdmK87J6x5mpCqakWHGhTN6t5BNyzsvSFFLo8mnO_4kzcpHST8a44kw9J2e8NGzN1-U5-XtDv7aQkN7RbQzQURiaeRN7cOOvMOAUHP027ZsDHT3dhl3wEIdQX1OgtzlhOnRThCF5jEvN0IY6TGO8Xpq20I9_gseBhoF-xgnSBHPj-4g50g0MDuML8sxDl_DlaV6S77cftptPxf2Xj3ebm_vCKSWmwotSO-FBN1VdOd5ICbKqhNbAdONMZRphmAdWi9ooNAoagZrXvGFO6Nqt5SV5e-zdxfFhj2myfUgOuw4GHPfJCp4LhDEZlEfQxTGliN7uYughHixndnZvZ7N2Nmtn93lnZb56farf1z02jzcn2Rl4cwIgOeh81uZCeuS00uVa6sxdHbk2_Gh_h4jWLZ4iJoTo2uXd8lj-A8aSmu8</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>21270277</pqid></control><display><type>article</type><title>A Phase I Trial and Pharmacokinetic Study of Tipifarnib, a Farnesyltransferase Inhibitor, and Tamoxifen in Metastatic Breast Cancer</title><source>MEDLINE</source><source>American Association for Cancer Research</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>LEBOWITZ, Peter F ; ENG-WONG, Jennifer ; WIDEMANN, Brigitte C ; BALIS, Frank M ; JAYAPRAKASH, Nalini ; CHOW, Catherine ; CLARK, Geoff ; GANTZ, Susan B ; VENZON, David ; ZUJEWSKIL, Joanne</creator><creatorcontrib>LEBOWITZ, Peter F ; ENG-WONG, Jennifer ; WIDEMANN, Brigitte C ; BALIS, Frank M ; JAYAPRAKASH, Nalini ; CHOW, Catherine ; CLARK, Geoff ; GANTZ, Susan B ; VENZON, David ; ZUJEWSKIL, Joanne</creatorcontrib><description>Purpose: Farnesyltransferase (FTase) inhibitors, which were designed to inhibit oncogenic Ras, act synergistically with tamoxifen
in preclinical breast cancer models. We studied the safety and toxicity of tipifarnib in combination with tamoxifen in metastatic
breast cancer. The pharmacokinetics and pharmacodynamics of tipifarnib were also assessed.
Patients and Methods: Patients with metastatic, hormone receptor–positive breast cancer were enrolled. Two cohorts of patients were treated with
tipifarnib at either 200 or 300 mg p.o. twice daily for 21 of 28 days. Tamoxifen (20 mg once daily) was started after 1 week
of tipifarnib monotherapy to perform pharmacokinetics and FTase inhibition levels in peripheral blood mononuclear cells with
tipifarnib alone and with tipifarnib and tamoxifen.
Results: A total of 12 heavily pretreated patients with prior progression on hormonal therapy were enrolled. Minimal toxicity was
observed at the 200-mg dose level of tipifarnib. At the 300-mg dose, all six patients required dose reduction of tipifarnib
due to toxicities that included grade 2 nausea, rash, and fatigue and grade 3 diarrhea and neutropenia. Tipifarnib pharmacokinetic
and pharmacodynamic variables were similar in the presence and absence of tamoxifen. Average FTase inhibition was 42% at 200
mg and 54% at 300 mg in peripheral blood mononuclear cells. Of the 12 patients treated, there were two partial responses and
one stable disease for >6 months.
Conclusions: Tipifarnib (200 mg twice daily for 21 of 28 days) and tamoxifen (20 mg once daily) can be given safely with minimal toxicity.
Tamoxifen does not have a significant effect on tipifarnib pharmacokinetics.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>DOI: 10.1158/1078-0432.1247.11.3</identifier><identifier>PMID: 15709195</identifier><language>eng</language><publisher>Philadelphia, PA: American Association for Cancer Research</publisher><subject>Adult ; Aged ; Alkyl and Aryl Transferases - antagonists & inhibitors ; Alkyl and Aryl Transferases - metabolism ; Anemia - chemically induced ; Antineoplastic agents ; Antineoplastic Agents, Hormonal - administration & dosage ; Antineoplastic Agents, Hormonal - therapeutic use ; Antineoplastic Combined Chemotherapy Protocols - therapeutic use ; Area Under Curve ; Biological and medical sciences ; Breast Neoplasms - drug therapy ; Breast Neoplasms - metabolism ; Dose-Response Relationship, Drug ; Exanthema - chemically induced ; Farnesyltranstransferase ; Fatigue - chemically induced ; Female ; Gynecology. Andrology. Obstetrics ; Humans ; Leukocytes, Mononuclear - drug effects ; Leukocytes, Mononuclear - enzymology ; Male ; Mammary gland diseases ; Medical sciences ; Middle Aged ; Neoplasm Metastasis ; Pharmacology. Drug treatments ; Quinolones - administration & dosage ; Quinolones - adverse effects ; Quinolones - pharmacokinetics ; Tamoxifen - administration & dosage ; Tamoxifen - therapeutic use ; Treatment Outcome ; Tumors</subject><ispartof>Clinical cancer research, 2005-02, Vol.11 (3), p.1247-1252</ispartof><rights>2005 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c442t-f256c2fa6d8b8c1d33a388266a06dc787d270fa0b2b74e74ad2e61b1d0c26bc93</citedby><cites>FETCH-LOGICAL-c442t-f256c2fa6d8b8c1d33a388266a06dc787d270fa0b2b74e74ad2e61b1d0c26bc93</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,776,780,3343,27901,27902</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=16465936$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15709195$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>LEBOWITZ, Peter F</creatorcontrib><creatorcontrib>ENG-WONG, Jennifer</creatorcontrib><creatorcontrib>WIDEMANN, Brigitte C</creatorcontrib><creatorcontrib>BALIS, Frank M</creatorcontrib><creatorcontrib>JAYAPRAKASH, Nalini</creatorcontrib><creatorcontrib>CHOW, Catherine</creatorcontrib><creatorcontrib>CLARK, Geoff</creatorcontrib><creatorcontrib>GANTZ, Susan B</creatorcontrib><creatorcontrib>VENZON, David</creatorcontrib><creatorcontrib>ZUJEWSKIL, Joanne</creatorcontrib><title>A Phase I Trial and Pharmacokinetic Study of Tipifarnib, a Farnesyltransferase Inhibitor, and Tamoxifen in Metastatic Breast Cancer</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>Purpose: Farnesyltransferase (FTase) inhibitors, which were designed to inhibit oncogenic Ras, act synergistically with tamoxifen
in preclinical breast cancer models. We studied the safety and toxicity of tipifarnib in combination with tamoxifen in metastatic
breast cancer. The pharmacokinetics and pharmacodynamics of tipifarnib were also assessed.
Patients and Methods: Patients with metastatic, hormone receptor–positive breast cancer were enrolled. Two cohorts of patients were treated with
tipifarnib at either 200 or 300 mg p.o. twice daily for 21 of 28 days. Tamoxifen (20 mg once daily) was started after 1 week
of tipifarnib monotherapy to perform pharmacokinetics and FTase inhibition levels in peripheral blood mononuclear cells with
tipifarnib alone and with tipifarnib and tamoxifen.
Results: A total of 12 heavily pretreated patients with prior progression on hormonal therapy were enrolled. Minimal toxicity was
observed at the 200-mg dose level of tipifarnib. At the 300-mg dose, all six patients required dose reduction of tipifarnib
due to toxicities that included grade 2 nausea, rash, and fatigue and grade 3 diarrhea and neutropenia. Tipifarnib pharmacokinetic
and pharmacodynamic variables were similar in the presence and absence of tamoxifen. Average FTase inhibition was 42% at 200
mg and 54% at 300 mg in peripheral blood mononuclear cells. Of the 12 patients treated, there were two partial responses and
one stable disease for >6 months.
Conclusions: Tipifarnib (200 mg twice daily for 21 of 28 days) and tamoxifen (20 mg once daily) can be given safely with minimal toxicity.
Tamoxifen does not have a significant effect on tipifarnib pharmacokinetics.</description><subject>Adult</subject><subject>Aged</subject><subject>Alkyl and Aryl Transferases - antagonists & inhibitors</subject><subject>Alkyl and Aryl Transferases - metabolism</subject><subject>Anemia - chemically induced</subject><subject>Antineoplastic agents</subject><subject>Antineoplastic Agents, Hormonal - administration & dosage</subject><subject>Antineoplastic Agents, Hormonal - therapeutic use</subject><subject>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</subject><subject>Area Under Curve</subject><subject>Biological and medical sciences</subject><subject>Breast Neoplasms - drug therapy</subject><subject>Breast Neoplasms - metabolism</subject><subject>Dose-Response Relationship, Drug</subject><subject>Exanthema - chemically induced</subject><subject>Farnesyltranstransferase</subject><subject>Fatigue - chemically induced</subject><subject>Female</subject><subject>Gynecology. Andrology. Obstetrics</subject><subject>Humans</subject><subject>Leukocytes, Mononuclear - drug effects</subject><subject>Leukocytes, Mononuclear - enzymology</subject><subject>Male</subject><subject>Mammary gland diseases</subject><subject>Medical sciences</subject><subject>Middle Aged</subject><subject>Neoplasm Metastasis</subject><subject>Pharmacology. Drug treatments</subject><subject>Quinolones - administration & dosage</subject><subject>Quinolones - adverse effects</subject><subject>Quinolones - pharmacokinetics</subject><subject>Tamoxifen - administration & dosage</subject><subject>Tamoxifen - therapeutic use</subject><subject>Treatment Outcome</subject><subject>Tumors</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2005</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpFkE2LFDEQhoMo7of-AkFyUfawPeark57jOri6sKLgeA7V6Yod7Y_ZpAeds3_cdM_InuqleOoteAh5xdmK87J6x5mpCqakWHGhTN6t5BNyzsvSFFLo8mnO_4kzcpHST8a44kw9J2e8NGzN1-U5-XtDv7aQkN7RbQzQURiaeRN7cOOvMOAUHP027ZsDHT3dhl3wEIdQX1OgtzlhOnRThCF5jEvN0IY6TGO8Xpq20I9_gseBhoF-xgnSBHPj-4g50g0MDuML8sxDl_DlaV6S77cftptPxf2Xj3ebm_vCKSWmwotSO-FBN1VdOd5ICbKqhNbAdONMZRphmAdWi9ooNAoagZrXvGFO6Nqt5SV5e-zdxfFhj2myfUgOuw4GHPfJCp4LhDEZlEfQxTGliN7uYughHixndnZvZ7N2Nmtn93lnZb56farf1z02jzcn2Rl4cwIgOeh81uZCeuS00uVa6sxdHbk2_Gh_h4jWLZ4iJoTo2uXd8lj-A8aSmu8</recordid><startdate>20050201</startdate><enddate>20050201</enddate><creator>LEBOWITZ, Peter F</creator><creator>ENG-WONG, Jennifer</creator><creator>WIDEMANN, Brigitte C</creator><creator>BALIS, Frank M</creator><creator>JAYAPRAKASH, Nalini</creator><creator>CHOW, Catherine</creator><creator>CLARK, Geoff</creator><creator>GANTZ, Susan B</creator><creator>VENZON, David</creator><creator>ZUJEWSKIL, Joanne</creator><general>American Association for Cancer Research</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7U7</scope><scope>C1K</scope></search><sort><creationdate>20050201</creationdate><title>A Phase I Trial and Pharmacokinetic Study of Tipifarnib, a Farnesyltransferase Inhibitor, and Tamoxifen in Metastatic Breast Cancer</title><author>LEBOWITZ, Peter F ; ENG-WONG, Jennifer ; WIDEMANN, Brigitte C ; BALIS, Frank M ; JAYAPRAKASH, Nalini ; CHOW, Catherine ; CLARK, Geoff ; GANTZ, Susan B ; VENZON, David ; ZUJEWSKIL, Joanne</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c442t-f256c2fa6d8b8c1d33a388266a06dc787d270fa0b2b74e74ad2e61b1d0c26bc93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2005</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Alkyl and Aryl Transferases - antagonists & inhibitors</topic><topic>Alkyl and Aryl Transferases - metabolism</topic><topic>Anemia - chemically induced</topic><topic>Antineoplastic agents</topic><topic>Antineoplastic Agents, Hormonal - administration & dosage</topic><topic>Antineoplastic Agents, Hormonal - therapeutic use</topic><topic>Antineoplastic Combined Chemotherapy Protocols - therapeutic use</topic><topic>Area Under Curve</topic><topic>Biological and medical sciences</topic><topic>Breast Neoplasms - drug therapy</topic><topic>Breast Neoplasms - metabolism</topic><topic>Dose-Response Relationship, Drug</topic><topic>Exanthema - chemically induced</topic><topic>Farnesyltranstransferase</topic><topic>Fatigue - chemically induced</topic><topic>Female</topic><topic>Gynecology. Andrology. Obstetrics</topic><topic>Humans</topic><topic>Leukocytes, Mononuclear - drug effects</topic><topic>Leukocytes, Mononuclear - enzymology</topic><topic>Male</topic><topic>Mammary gland diseases</topic><topic>Medical sciences</topic><topic>Middle Aged</topic><topic>Neoplasm Metastasis</topic><topic>Pharmacology. Drug treatments</topic><topic>Quinolones - administration & dosage</topic><topic>Quinolones - adverse effects</topic><topic>Quinolones - pharmacokinetics</topic><topic>Tamoxifen - administration & dosage</topic><topic>Tamoxifen - therapeutic use</topic><topic>Treatment Outcome</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>LEBOWITZ, Peter F</creatorcontrib><creatorcontrib>ENG-WONG, Jennifer</creatorcontrib><creatorcontrib>WIDEMANN, Brigitte C</creatorcontrib><creatorcontrib>BALIS, Frank M</creatorcontrib><creatorcontrib>JAYAPRAKASH, Nalini</creatorcontrib><creatorcontrib>CHOW, Catherine</creatorcontrib><creatorcontrib>CLARK, Geoff</creatorcontrib><creatorcontrib>GANTZ, Susan B</creatorcontrib><creatorcontrib>VENZON, David</creatorcontrib><creatorcontrib>ZUJEWSKIL, Joanne</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Toxicology Abstracts</collection><collection>Environmental Sciences and Pollution Management</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>LEBOWITZ, Peter F</au><au>ENG-WONG, Jennifer</au><au>WIDEMANN, Brigitte C</au><au>BALIS, Frank M</au><au>JAYAPRAKASH, Nalini</au><au>CHOW, Catherine</au><au>CLARK, Geoff</au><au>GANTZ, Susan B</au><au>VENZON, David</au><au>ZUJEWSKIL, Joanne</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A Phase I Trial and Pharmacokinetic Study of Tipifarnib, a Farnesyltransferase Inhibitor, and Tamoxifen in Metastatic Breast Cancer</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2005-02-01</date><risdate>2005</risdate><volume>11</volume><issue>3</issue><spage>1247</spage><epage>1252</epage><pages>1247-1252</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>Purpose: Farnesyltransferase (FTase) inhibitors, which were designed to inhibit oncogenic Ras, act synergistically with tamoxifen
in preclinical breast cancer models. We studied the safety and toxicity of tipifarnib in combination with tamoxifen in metastatic
breast cancer. The pharmacokinetics and pharmacodynamics of tipifarnib were also assessed.
Patients and Methods: Patients with metastatic, hormone receptor–positive breast cancer were enrolled. Two cohorts of patients were treated with
tipifarnib at either 200 or 300 mg p.o. twice daily for 21 of 28 days. Tamoxifen (20 mg once daily) was started after 1 week
of tipifarnib monotherapy to perform pharmacokinetics and FTase inhibition levels in peripheral blood mononuclear cells with
tipifarnib alone and with tipifarnib and tamoxifen.
Results: A total of 12 heavily pretreated patients with prior progression on hormonal therapy were enrolled. Minimal toxicity was
observed at the 200-mg dose level of tipifarnib. At the 300-mg dose, all six patients required dose reduction of tipifarnib
due to toxicities that included grade 2 nausea, rash, and fatigue and grade 3 diarrhea and neutropenia. Tipifarnib pharmacokinetic
and pharmacodynamic variables were similar in the presence and absence of tamoxifen. Average FTase inhibition was 42% at 200
mg and 54% at 300 mg in peripheral blood mononuclear cells. Of the 12 patients treated, there were two partial responses and
one stable disease for >6 months.
Conclusions: Tipifarnib (200 mg twice daily for 21 of 28 days) and tamoxifen (20 mg once daily) can be given safely with minimal toxicity.
Tamoxifen does not have a significant effect on tipifarnib pharmacokinetics.</abstract><cop>Philadelphia, PA</cop><pub>American Association for Cancer Research</pub><pmid>15709195</pmid><doi>10.1158/1078-0432.1247.11.3</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Clinical cancer research, 2005-02, Vol.11 (3), p.1247-1252 |
| issn | 1078-0432 1557-3265 |
| language | eng |
| recordid | cdi_proquest_miscellaneous_21270277 |
| source | MEDLINE; American Association for Cancer Research; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Adult Aged Alkyl and Aryl Transferases - antagonists & inhibitors Alkyl and Aryl Transferases - metabolism Anemia - chemically induced Antineoplastic agents Antineoplastic Agents, Hormonal - administration & dosage Antineoplastic Agents, Hormonal - therapeutic use Antineoplastic Combined Chemotherapy Protocols - therapeutic use Area Under Curve Biological and medical sciences Breast Neoplasms - drug therapy Breast Neoplasms - metabolism Dose-Response Relationship, Drug Exanthema - chemically induced Farnesyltranstransferase Fatigue - chemically induced Female Gynecology. Andrology. Obstetrics Humans Leukocytes, Mononuclear - drug effects Leukocytes, Mononuclear - enzymology Male Mammary gland diseases Medical sciences Middle Aged Neoplasm Metastasis Pharmacology. Drug treatments Quinolones - administration & dosage Quinolones - adverse effects Quinolones - pharmacokinetics Tamoxifen - administration & dosage Tamoxifen - therapeutic use Treatment Outcome Tumors |
| title | A Phase I Trial and Pharmacokinetic Study of Tipifarnib, a Farnesyltransferase Inhibitor, and Tamoxifen in Metastatic Breast Cancer |
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