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Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Advanced Cancer

Thank you

Trial Information

Phase I Clinical Trial of Suberoylanilide Hydroxamic Acid (SAHA) in Combination With Pemetrexed and Cisplatin in Patients With Advanced Cancer


Inclusion Criteria:



- 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

Exclusion Criteria:

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Cycle 1 (21 days)

Safety Issue:

Yes

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Merck

Authority:

United States: Food and Drug Administration

Study ID:

2005_006

NCT ID:

NCT00106626

Start Date:

August 2005

Completion Date:

December 2007

Related Keywords:

  • Advanced Cancer
  • Advanced solid tumors including MPM and NSCLC
  • Neoplasms

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