Tipifarnib in Treating Patients With Relapsed or Refractory Lymphoma

This study is ongoing, but not recruiting participants.

Study NCT00082888 Information provided by Mayo Clinic

First Received on May 14, 2004. Last Updated on November 2, 2011 History of Changes

Results First Received: November 2, 2011

Study Type:	Interventional
Study Design:	Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Conditions:	Leukemia Lymphoma
Intervention:	Drug: Tipifarnib

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 2 medical clinics in the United States between March 2004 to November 2008.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
R115777 (Tipifarnib)	300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.

Participant Flow: Overall Study

	R115777 (Tipifarnib)
STARTED	93
COMPLETED	71
NOT COMPLETED	22
Death	2
Adverse Event	4
Withdrawal by Subject	9
Alternate Treatment	1
Other Medical Problems	2
Still receiving treatment	4

Baseline Characteristics

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Reporting Groups

	Description
R115777 (Tipifarnib)	300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.

Baseline Measures

	R115777 (Tipifarnib)
Number of Participants [units: participants]	93
Age [units: years] Median ( Full Range )	62 ( 18 to 91 )
Gender [units: participants]
Female	42
Male	51
Region of Enrollment [units: participants]
United States	93
Relapsed or Refractory Lymphoma [units: participants]
Aggressive	42
Indolent	15
Uncommon	36

Outcome Measures

1. Primary:

Proportion of Confirmed Response (Complete Response, Unconfirmed Complete Response, or Partial Response) During the First 6 Courses of Treatment [ Time Frame: During the first 6 cycles of treatment ]

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2. Secondary:

Overall Survival [ Time Frame: Up to 2 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

3. Secondary:

Time to Progression [ Time Frame: up to 2 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

4. Secondary:

Duration of Response [ Time Frame: up to 2 years ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

5. Secondary:

Toxicity [ Time Frame: 3/26/2004 - 2/1/2011 ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: Yes

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Thomas E. Witzig, M.D.
Organization: Mayo Clinic
phone: 507-266-2040
e-mail: witzig@mayo.edu

No publications provided by Mayo Clinic

Publications automatically indexed to this study:

Witzig TE, Tang H, Micallef IN, Ansell SM, Link BK, Inwards DJ, Porrata LF, Johnston PB, Colgan JP, Markovic SN, Nowakowski GS, Thompson CA, Allmer C, Maurer MJ, Gupta M, Weiner G, Hohl R, Kurtin PJ, Ding H, Loegering D, Schneider P, Peterson K, Habermann TM, Kaufmann SH. Multi-institutional phase 2 study of the farnesyltransferase inhibitor tipifarnib (R115777) in patients with relapsed and refractory lymphomas. Blood. 2011 Nov 3;118(18):4882-9. Epub 2011 Jul 1.

Responsible Party:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00082888 History of Changes
Other Study ID Numbers:	CDR0000360887, P50CA097274, P30CA015083, LS038B, 6246
Study First Received:	May 14, 2004
Results First Received:	November 2, 2011
Last Updated:	November 2, 2011
Health Authority:	United States: Food and Drug Administration