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A Study of MK1775 in Combination With Topotecan/Cisplatin in Patients With Cervical Cancer (1775-008)

2014-08-27 03:15:36 | BioPortfolio

Summary

This study will be conducted in two parts. Part 1 will determine whether administration of MK1775 in combination with topotecan and cisplatin is generally well-tolerated and causes clinical objective responses in patients with cervical cancer. Part 1 will also define the recommended Phase 2 dose and maximum tolerated dose (MTD) of the combination of MK1775 with topotecan and cisplatin. Part 2 of the study will evaluate whether treatment with MK1775 in combination with topotecan and cisplatin causes an improvement in progression-free survival (PFS) compared to treatment with topotecan and cisplatin alone and will further evaluate the tolerability of the combination treatment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Cervical Cancer

Intervention

MK1775 + topotecan + cisplatin, Comparator: MK1775 + topotecan + cisplatin, Comparator: Placebo to MK1775 + topotecan + cisplatin

Status

Terminated

Source

Merck

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:15:36-0400

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A Dose Escalation Study of MK1775 in Combination With Either Gemcitabine, Cisplatin, or Carboplatin in Adults With Advanced Solid Tumors

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A Dose Escalation Study of MK1775 in Combination With 5-FU or 5-FU/CDDP in Patients With Advanced Solid Tumor (1775-005)

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PubMed Articles [417 Associated PubMed Articles listed on BioPortfolio]

Topotecan effect on the structure of normal and cancer plasma membrane lipid models: A multi-model approach.

Topotecan is a relatively large, planar, asymmetric and polar molecule with a lactone moiety. In neutral or basic aqueous solutions, this ring opens forming the carboxylate form of Topotecan that is b...

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Topotecan is one of the most active chemotherapeutic drugs for small cell lung cancer (SCLC). However, its efficacy in elderly patients with SCLC has not been validated. This study evaluated the feasi...

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ADP sensitizes ZL55 cells to the activity of cisplatin.

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A randomised phase II trial of capecitabine plus cisplatin versus S-1 plus cisplatin as a first-line treatment for advanced gastric cancer: Capecitabine plus cisplatin ascertainment versus S-1 plus cisplatin randomised PII trial (XParTS II).

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Medical and Biotech [MESH] Definitions

An inorganic and water-soluble platinum complex. After undergoing hydrolysis, it reacts with DNA to produce both intra and interstrand crosslinks. These crosslinks appear to impair replication and transcription of DNA. The cytotoxicity of cisplatin correlates with cellular arrest in the G2 phase of the cell cycle.

An antineoplastic agent used to treat ovarian cancer. It works by inhibiting DNA TOPOISOMERASES, TYPE I.

A competitive serotonin type 3 receptor antagonist. It is effective in the treatment of nausea and vomiting caused by cytotoxic chemotherapy drugs, including cisplatin, and has reported anxiolytic and neuroleptic properties.

Organic cation transporter consisting of twelve transmembrane domains and expressed primarily in the kidney. It transports a wide range of metabolites, drugs, and neurotransmitters from the blood to the KIDNEY TUBULES, including DOPAMINE; SEROTONIN; CHOLINE; and CISPLATIN.

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