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A Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer

Phase 1
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

A Trial of Cabozantinib (XL184) and Gemcitabine in Advanced Pancreatic Cancer

Preclinical work at the University of Michigan has demonstrated that inhibition of c-Met
with cabozantinib prevented the development of metastatic disease in an intra-cardiac
injection model in NOD/SCID mice. Additionally, the combination of cabozantinib and
gemcitabine demonstrated improved tumor control compared to either agent alone in a relevant
orthotopic implantation mouse model.

Combining gemcitabine with the c-Met inhibitor cabozantinib in advanced pancreatic cancer is
a novel strategy that takes advantage of an established cytotoxic agent with one that
targets a pathway known to be important for the growth, dissemination, and resistance of
this disease.

Inclusion Criteria:

1. pathologically confirmed pancreatic carcinoma.

2. locally advanced unresectable disease, metastatic disease, or recurrent disease
following surgical therapy.

3. ≥ 18 years old.

4. Life expectancy of greater than 12 weeks.

5. ECOG performance status ≤1 (Karnofsky ≥70%) (See Appendix A).

6. adequate organ and marrow function as follows:

7. capable of understanding and complying with the protocol requirements and has signed
the informed consent document.

8. use medically accepted barrier methods of contraception

9. women of childbearing potential must have a negative pregnancy test at screening.

Exclusion Criteria:

1. neuroendocrine tumors of the pancreas.

2. more than 1 prior systemic treatment regimen for pancreatic cancer. may have received
prior neoadjuvant or adjuvant therapy, including gemcitabine, provided 6 months have
elapsed from completion of that treatment and the start of study therapy.

3. Previous gemcitabine therapy for advanced pancreatic cancer. Patients who have had
chemotherapy within 4 weeks, nitrosoureas/mitomycin C within 6 weeks, or monoclonal
antibody within 6 weeks prior to planned initiation of study treatment.

4. prior treatment with a small molecule kinase inhibitor or a hormonal therapy within
14 days or five half-lives of the compound or active metabolites, whichever is
longer, before the first dose of study treatment.

5. have received an investigational agent within 28 days of the first dose of study
treatment or 5 half-lives of the compound or active metabolite, whichever is longer.

6. have received radiation therapy within 14 days of study treatment.

7. have not recovered from toxicity due to all prior therapies (i.e., return to
pretherapy baseline or to CTCAE Grade 0 or 1) except alopecia and non-clinically
significant AEs.

8. known brain metastases.

Type of Study:


Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose

Outcome Description:

The MTD is defined at the highest dose level at which ≤25% of patients experience a dose-limiting toxicity (DLT).

Outcome Time Frame:

5 weeks

Safety Issue:


Principal Investigator

Mark Zalupski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Food and Drug Administration

Study ID:

UMCC 2011.105



Start Date:

July 2012

Completion Date:

January 2019

Related Keywords:

  • Pancreatic Cancer
  • oncology
  • pancrease
  • Pancreatic Neoplasms



University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752