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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Melanoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Maximum tolerated dose (MTD) or recommended Phase II dose of INO-1001 to be used in combination with TMZ

Outcome Time Frame:

Length of study

Principal Investigator

Jennifer Low, M.D., Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

IPC-06-2004

NCT ID:

NCT00272415

Start Date:

October 2005

Completion Date:

Related Keywords:

  • Melanoma
  • INO4136g
  • inotek
  • Parp
  • Temodar
  • Melanoma

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