A Study of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate Tolerability, Safety, and Pharmacokinetics in Patients With Melanoma

Melanoma Clinical Trial

Official title:

A Phase Ib, Open-Label, Multicenter Trial of Intravenous INO-1001 Plus Oral Temozolomide to Evaluate the Tolerability, Safety, and Pharmacokinetics in Subjects With Newly-Diagnosed or Recurrent Unresectable Stage III or Stage IV Melanoma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00272415
• Other study ID #: IPC-06-2004
• Secondary ID: INO4136g
• Status: Terminated
• Phase: Phase 1
• First received: January 3, 2006
• Last updated: March 9, 2009
• Start date: October 2005

Study information

• Verified date: November 2007
• Source: Genentech, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a prospective, open-label, non-randomized, multicenter study in adults, aged eighteen (18) or older, with newly-diagnosed or recurrent unresectable Stage III or Stage IV melanoma. A maximum of 18 subjects will be enrolled in Stage 1 of this study. (Stage 1 completed enrollment in June 2006.) A maximum of 39 subjects will be enrolled in Stage 2 of this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Biopsy proven malignant melanoma with metastasis that is unresectable Stage III or Stage IV. Subjects with recurrent melanoma that is unresectable are also eligible

• Measurable indicator metastases

• Age 18 years or older

• ECOG status 0-2

• An interval at the time of enrollment of at least: a) 2 weeks since surgical resection (if conducted); b) 4 weeks since prior radiotherapy or chemotherapy, and c) 6 weeks since chemotherapy with a nitrosourea

• Hematocrit > 29%, ANC > 1500 cells/ul, platelets > 100,000 cells/ul

• Serum creatinine within the laboratory's upper limit of normal

• Serum AST and ALT = 1.5 x the laboratory's upper limit of normal

• Subject signed informed consent prior to subject entry

Exclusion Criteria:

• Female patients who are pregnant or breast-feeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to administration of each cycle of the study drug regimen.

• Subjects of childbearing potential who are not willing or able to use an effective method of contraception, consisting of at least one-barrier method (e.g., condom and diaphragm), for the duration of the study and for at least 3 months after completing the treatment.

• Subjects previously treated with DTIC or TMZ

• Symptomatic central nervous metastases

• Concurrent severe and/or uncontrolled medical disease that could compromise participation in the study.

• Confirmed diagnosis of hepatitis or HIV infection

• Any medical, psychiatric, or social problem that might interfere with the performance, completion, and/or interpretation of the trial

• Patients who have had any surgery within two weeks prior to enrollment in this study, or who have not recovered from the side effects of this or any other therapy

• Patients unwilling to comply with the protocol or who in the judgment of the Principal Investigator are unable to abide by the rules of the protocol

• Subjects who have received a potent CYP3A4 inhibitor or inducer orally or parenterally within approximately 14 days prior to enrollment

• Subjects who have received amiodarone within 30 days of study drug administration

• History of hypersensitivity reaction to more than three (3) drugs or to mannitol

• Patients who have received any investigational study agent within 30 days of Day 1 of Cycle 1

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Melanoma

Intervention

Drug:
• INO-1001
Intravenous repeating dose
• temozolomide
Oral repeating dose

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genentech, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ		Length of study
Primary	Pharmacokinetic (PK) profile of intravenous INO-1001		Length of study
Primary	Safety and tolerability of combined therapy with oral temozolomide (TMZ) and intravenous INO-1001		Length of study
Secondary	Safety of repeat dosing		Length of study
Secondary	Pharmacodynamic (PD) activity of intravenous INO-1001		Length of study
Secondary	Response		Length of study
Secondary	Progression-free survival		Length of study
Secondary	Overall survival		Length of study