Pazopanib, Pemetrexed and Crizotinib for Advanced Disease
Pazopanib, Pemetrexed and Crizotinib for Advanced Disease
A Two Steps Phase I Trial of Pazopanib or Pemetrexed in Combination With Crizotinib Followed by the Triplet, Crizotinib Plus Pazopanib Plus Pemetrexed in Patients With Advanced Malignancies (2011-1142) Summary Using a combination of drugs may be more effective than using one drug alone for treating advanced breast cancer. Crizotinib (Xalkori) blocks a protein called ALK, which is involved in cancer cell growth and survival. It is approved to treat some types of non-small cell lung cancer. Pazopanib (Votrient) blocks the growth of blood vessels that supply nutrients needed for tumor growth. It is approved for the treatment of advanced kidney cancer. Pemetrexed (Alimta) blocks proteins that may cause tumors to grow. It is approved for the treatment of non-small cell lung cancer. The goal of this trial is to identify the highest tolerable dose and to study the safety of the combination of crizotinib and pazopanib; crizotinib and pemetrexed; and crizotinib, pazopanib and pemetrexed in patients with advanced breast cancer. Patients with other types of advanced cancer are also being enrolled in this study. This is a Phase I trial |
Re: Pazopanib, Pemetrexed and Crizotinib for Advanced Disease
Thanks for posting these!
I also believe that a drug combo should work better for most people. Will be interesting to see how the results come in on these. There are too many pathways for one drug to be successful at finding and closing off. |
Re: Pazopanib, Pemetrexed and Crizotinib for Advanced Disease
I checked again for a Phase II and realized the Phase I completes in 4 years - wow seems like a long time for Phase I.
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Re: Pazopanib, Pemetrexed and Crizotinib for Advanced Disease
Pazopanib or Pemetrexed and Crizotinib in Advanced Cancer
This study is currently recruiting participants. (see Contacts and Locations) Verified February 2014 by M.D. Anderson Cancer Center Sponsor: M.D. Anderson Cancer Center Information provided by (Responsible Party): M.D. Anderson Cancer Center ClinicalTrials.gov Identifier: NCT01548144 First received: March 5, 2012 Last updated: February 18, 2014 Last verified: February 2014 History of Changes
http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Purpose The goal of this clinical research study is to find the highest tolerable dose of the combination of Xalkori (crizotinib) either with Votrient (pazopanib) or Alimta (pemetrexed) or of the combination of 3 study drugs that can be given to patients with advanced cancer. The safety of these drug combinations will also be studied. Crizotinib is designed to block a protein called ALK, which is involved in cancer cell growth and survival. Pazopanib is designed to block the growth of blood vessels that supply nutrients needed for tumor growth. This may prevent or slow the growth of cancer cells. Pemetrexed is designed to block proteins that may cause tumors to grow. Condition Intervention Phase Advanced Cancers Drug: Crizotinib (Xalkori) Drug: Pazopanib Drug: Pemetrexed Phase 1 Study Type: Interventional Study Design: Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment Official Title: A Two Steps Phase I Trial of Pazopanib or Pemetrexed in Combination With Crizotinib Followed by the Triplet, Crizotinib Plus Pazopanib Plus Pemetrexed in Patients With Advanced Malignancies Resource links provided by NLM: MedlinePlus related topics: Cancer Drug Information available for: Pemetrexed Pemetrexed disodium Pazopanib Crizotinib U.S. FDA Resources Further study details as provided by M.D. Anderson Cancer Center: Primary Outcome Measures:
Estimated Enrollment: 364 Study Start Date: April 2012 Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure) Arms Assigned Interventions Experimental: Crizotinib (Xalkori) + Pazopanib Starting dose for Crizotinib: 250 mg by mouth every other day, 1 or 2 times a day on Day 1 of a 21 day cycle. Participant told how often to take this drug. Dose Expansion Group: MTD from Phase 1. Starting Dose for Pazopanib: 200 mg by mouth daily in a 21 day cycle. Dose Expansion Group: MTD from Phase 1. Drug: Crizotinib (Xalkori) Starting dose for Crizotinib: 250 mg by mouth every other day, 1 or 2 times a day on Day 1 of a 21 day cycle. Participant told how often to take this drug. Dose Expansion Group: MTD from Phase 1. Other Names:
Drug: Pazopanib Starting Dose for Pazopanib: 200 mg by mouth daily in a 21 day cycle. Dose Expansion Group: MTD from Phase 1. Other Name: GW786034 Experimental: Crizotinib (Xalkori) + Pemetrexed Starting dose for Crizotinib: 250 mg by mouth every other day, 1 or 2 times a day on Day 1 of a 21 day cycle. Participant told how often to take this drug. Dose Expansion Group: MTD from Phase 1. Starting dose for Pemetrexed: 200 mg/m2 by vein every 3 weeks on Day 1 of a 21 day cycle. Dose Expansion Group: MTD from Phase 1. Drug: Crizotinib (Xalkori) Starting dose for Crizotinib: 250 mg by mouth every other day, 1 or 2 times a day on Day 1 of a 21 day cycle. Participant told how often to take this drug. Dose Expansion Group: MTD from Phase 1. Other Names:
Drug: Pemetrexed Starting dose for Pemetrexed: 200 mg/m2 by vein on Day 1 of a 21 day cycle. Expansion group starting dose: MTD from Phase 1. Starting dose for Pemetrexed: 400 mg/m2 by vein every 3 weeks on Day 1 of a 21 day cycle. Other Names:
Experimental: Pazopanib + Pemetrexed Starting dose for Pazopanib: 200 mg by mouth daily in a 21 day cycle. Expansion group starting dose: MTD from Phase 1. Starting dose for Pemetrexed: 200 mg/m2 by vein on Day 1 of a 21 day cycle. Expansion group starting dose: MTD from Phase 1. Drug: Pazopanib Starting Dose for Pazopanib: 200 mg by mouth daily in a 21 day cycle. Dose Expansion Group: MTD from Phase 1. Other Name: GW786034 Drug: Pemetrexed Starting dose for Pemetrexed: 200 mg/m2 by vein on Day 1 of a 21 day cycle. Expansion group starting dose: MTD from Phase 1. Starting dose for Pemetrexed: 400 mg/m2 by vein every 3 weeks on Day 1 of a 21 day cycle. Other Names:
Experimental: Crizotinib (Xalkori) + Pazopanib + Pemetrexed Starting dose for Crizotinib: 250 mg by mouth every other day, 1 or 2 times a day on Day 1 of a 21 day cycle. Participant told how often to take this drug. Dose Expansion Group: MTD from Phase 1. Starting Dose for Pazopanib: 200 mg by mouth daily in a 21 day cycle. Dose Expansion Group: MTD from Phase 1. Starting dose for Pemetrexed: 400 mg/m2 by vein every 3 weeks on Day 1 of a 21 day cycle. Dose Expansion Group: MTD from Phase 1. Drug: Crizotinib (Xalkori) Starting dose for Crizotinib: 250 mg by mouth every other day, 1 or 2 times a day on Day 1 of a 21 day cycle. Participant told how often to take this drug. Dose Expansion Group: MTD from Phase 1. Other Names:
Drug: Pazopanib Starting Dose for Pazopanib: 200 mg by mouth daily in a 21 day cycle. Dose Expansion Group: MTD from Phase 1. Other Name: GW786034 Drug: Pemetrexed Starting dose for Pemetrexed: 200 mg/m2 by vein on Day 1 of a 21 day cycle. Expansion group starting dose: MTD from Phase 1. Starting dose for Pemetrexed: 400 mg/m2 by vein every 3 weeks on Day 1 of a 21 day cycle. Other Names:
http://www.clinicaltrials.gov/ct2/ht...frame/plus.gif Show Detailed Description http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Eligibility Genders Eligible for Study: Both Accepts Healthy Volunteers: No Criteria Inclusion Criteria:
http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif Contacts and Locations Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies. Please refer to this study by its ClinicalTrials.gov identifier: NCT01548144 Contacts Contact: Ralph Zinner, MD, BA 713-563-1930 Locations United States, Texas UT MD Anderson Cancer Center Recruiting Houston, Texas, United States, 77030 Sponsors and Collaborators M.D. Anderson Cancer Center Investigators Principal Investigator: Ralph Zinner, MD,BA UT MD Anderson Cancer Center http://www.clinicaltrials.gov/ct2/ht...e/triangle.gif More Information Additional Information: UT MD Anderson Cancer Center Website http://www.clinicaltrials.gov/ct2/ht...frame/exit.bmp No publications provided Responsible Party: M.D. Anderson Cancer Center ClinicalTrials.gov Identifier: NCT01548144 History of Changes Other Study ID Numbers: 2011-1142 Study First Received: March 5, 2012 Last Updated: February 18, 2014 Health Authority: United States: Institutional Review Board Keywords provided by M.D. Anderson Cancer Center: Crizotinib PF-02341066 Pazopanib Gw786034 Pemetrexed LY231514 Alimta Multitargeted Antifolate Advanced Cancers Advanced Malignancies MTA NSC-698037 Additional relevant MeSH terms: Neoplasms Folic Acid Antagonists Pemetrexed Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites ClinicalTrials.gov processed this record on May 28, 2014 |
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