Suberoylanilide Hydroxamic Acid in Advanced Solid Tumors

NCT00106626 | Completed Phase 1 Results

• 2 other identifiers: 2005_006MK0683-012
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this investigational study is to determine the safety and tolerability of oral suberoylanilide hydroxamic acid when administered in combination with standard doses of pemetrexed and cisplatin for the treatment of advanced solid tumors.

Conditions

Advanced Cancer

Keywords

Advanced solid tumors including MPM and NSCLC

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) Status as Determined by Number of Participants With Dose Limiting Toxicity (DLT) at Each Dose Level

  MTD was determined by the occurrence of DLTs during the first treatment cycle. DLT describes side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment. The dose level is equal to the MTD if \< 2 patients experience a DLT and is also the highest tolerated dose level in the cohort.

  Cycle 1 (21 days)

Secondary Outcomes (1)

• Safety and Tolerability as Measured by the Number of Participants With Disease Progression

  Any time during 8 cycle treatment period through 30 days after.

Study Arms (1)

1

EXPERIMENTAL

vorinostat (Suberoylanilide Hydroxamic Acid \[SAHA\])

Drug: vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin

Interventions

vorinostat (Suberoylanilide Hydroxamic Acid [SAHA]) in combination with Pemetrexed and Cisplatin DRUG

Dose escalation study starting with vorinostat (Suberoylanilide Hydroxamic Acid \[SAHA\]) capsules 200 mg b.i.d. in combination with Pemetrexed and Cisplatin (see table for Reporting Groups).

Also known as: MK0683, vorinostat, Suberoylanilide Hydroxamic Acid (SAHA)

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must be 18 years or older with confirmed diagnosis of a solid tumor for which pemetrexed and cisplatin is acceptable treatment and have received no more than 2 prior systemic therapies
• Has at least 1 measurable lesion
• Has adequate blood, liver, and kidney functions
• Has not received any chemotherapy for at least 4 weeks prior to entry in this study
• Agrees to take adequate measures to prevent pregnancy as outlined in the protocol

You may not qualify if:

• Patient has been treated with other investigational agents with a similar anti-tumor mechanism
• Patient from Cohorts A and B has received pemetrexed or cisplatin within the past 6 months and from Cohorts C and D have received pemetrexed within the past 6 months
• Patient from Cohorts A and B has preexisting Grade 2 or higher neuropathy and from Cohorts C and D have Grade 3 or higher neuropathy
• Patient has active infection or had received IV (intravenous) antibiotic, antiviral, or antifungal medications within 2 weeks of the start of study drugs
• Patient has HIV, hepatitis B or hepatitis C infection
• Patient is pregnant or breast feeding
• Patient has allergy to any component of the study drugs
• Patient has history of GI (gastrointestinal) surgery or conditions

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Vorinostat; Pemetrexed; Cisplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Hydroxamic Acids; Hydroxylamines; Hydroxy Acids; Carboxylic Acids; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Results Point of Contact

• Title: Senior Vice President, Clinical and Quantitative Sciences
• Organization: Merck & Co., Inc.

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 28, 2005
• First Posted: March 29, 2005
• Study Start: August 1, 2005
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 22, 2009
• Results First Posted: April 22, 2009

Record last verified: 2009-03