A Study of 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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01209143
First received: September 23, 2010
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

This is a single-arm, multicenter, Phase Ib study designed to describe the effec t of GDC-0449 on the pharmacokinetics of rosiglitazone and oral contraceptives i n patients with advanced solid tumors who are refractory to treatment or for who m no standard therapy exists.


Condition Intervention Phase
Solid Cancers
Drug: GDC-0449
Drug: oral contraceptive
Drug: rosiglitazone
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • To evaluate the relative effect of GDC-0449 on the pharmacokinetics (Cmax and AUC) of oral contraceptive (OC; norethindrone and ethinyl estradiol) [ Time Frame: Days 1-9 ] [ Designated as safety issue: No ]
  • To evaluate the relative effect of GDC-0449 on the pharmacokinetics (Cmax and AUC) of rosiglitazone [ Time Frame: Days 1-9 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The safety objective of this study is to evaluate the safety and tolerability of GDC-0449 administered to patients with advanced solid tumors that are refractory to treatment or for whom no standard therapy exists [ Time Frame: 63 days, then every 4 weeks while patient is on study ] [ Designated as safety issue: No ]
  • The secondary efficacy objective of this study is to make a preliminary assessment of tumor response in patients with advanced solid tumors who are refractory to treatment or for whom no standard therapy exists receiving GDC-0449 [ Time Frame: 63 days, then every 8 weeks while patient is on study ] [ Designated as safety issue: No ]

Enrollment: 53
Study Start Date: November 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 Drug: GDC-0449
Oral repeating dose
Drug: rosiglitazone
Oral repeating dose
Experimental: Cohort 2 Drug: GDC-0449
Oral repeating dose
Drug: oral contraceptive
Oral repeating dose

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01209143

Locations
United States, California
Stanford, California, United States, 94305
United States, Michigan
Detroit, Michigan, United States, 48201
United States, Texas
Houston, Texas, United States, 77030
Sponsors and Collaborators
Genentech
Investigators
Study Director: Dawn Colburn, Pharm.D. Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01209143     History of Changes
Other Study ID Numbers: SHH4593g, GO01353
Study First Received: September 23, 2010
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Contraceptive Agents
Rosiglitazone
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Hypoglycemic Agents
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on September 16, 2014