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A Phase Ib, Open-Label, Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Cancers

Thank you

Trial Information

A Phase Ib, Open-Label, Pharmacokinetic Drug Interaction Study of the Hedgehog Pathway Inhibitor GDC-0449 in Combination With Rosiglitazone or Combined Oral Contraceptive in Patients With Locally Advanced or Metastatic Solid Tumors That Are Refractory to Standard Therapy or for Whom No Standard Therapy Exists


Inclusion Criteria:



- Histologic documentation of incurable, locally advanced, or metastatic solid
malignancy that has failed to respond to at least one prior regimen or for which
there is no standard therapy

- Documented negative serum pregnancy test for women of childbearing potential and use
of two forms of contraception. Contraception must be used while the patient is
enrolled in the study and for 12 months after the patient discontinues from the
study.

- For men with female partners of childbearing potential, agreement to use a latex
condom and to advise their female partner to use an additional method of
contraception during the study and for 3 months after their last dose of GDC-0449.

- Agreement not to donate blood or blood products during the study and for at least 12
months after their last dose of GDC-0449

- For male patients, agreement not to donate sperm during the study and for at least 3
months after their last dose of GDC-0449

- Adequate hematopoietic capacity

- Adequate renal function

- Adequate hepatic function

- At least 3 weeks since the patient's last chemotherapy, investigational agent,
radiation therapy, or major surgical procedure and recovery to pre-treatment baseline
or stabilization of all treatment-related toxicities

Exclusion Criteria:

- Active infection requiring intravenous (IV) antibiotics

- Clinically important history of liver disease significantly impairing hepatic
function, including active viral or other hepatitis, current alcohol abuse, or
cirrhosis

- Any medical condition or diagnosis that would likely impair absorption of an orally
administered drug

- Pregnant or lactating

- Treatment with excluded medications, including strong CYP450 inhibitors and inducers,
within 2 weeks of study entry

- Male patients already receiving rosiglitazone

- Male patients with a known contraindication to rosiglitazone

- Female patients already receiving oral contraception < 14 days prior to Day 1

- Female patients with known contraindication to oral contraceptions

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the relative effect of GDC-0449 on the pharmacokinetics (Cmax and AUC) of oral contraceptive (OC; norethindrone and ethinyl estradiol)

Outcome Time Frame:

Days 1-9

Safety Issue:

No

Principal Investigator

Dawn Colburn, Pharm.D.

Investigator Role:

Study Director

Investigator Affiliation:

Genentech

Authority:

United States: Food and Drug Administration

Study ID:

SHH4593g

NCT ID:

NCT01209143

Start Date:

November 2010

Completion Date:

July 2012

Related Keywords:

  • Solid Cancers

Name

Location

Fountain Valley, California  92708
Austin, Texas  78705
Flint, Michigan  48532