Maintenance Dovitinib for Colorectal and Pancreas Cancer

NCT01888965 | Terminated Phase 2 Results DMC

• 2 other identifiers: CTK1258AUS16TPro063
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study is for patients with stage 4 colon cancer who have had initial chemotherapy or had surgery to remove metastases and patients with pancreas cancer, which has been surgically removed and are receiving adjuvant chemotherapy or is locally advanced and have already received chemotherapy and radiation. The purpose of this study is to determine the effects of oral dovitinib in patients with advanced stage colorectal and pancreas. Effects include biomarker changes, progression-free survival and safety. Dovitinib will be taken by mouth for 5 days out of every week for up to 2 years.

Conditions

Colorectal Cancer; Pancreas Cancer

Keywords

Maintenance therapy; Adjuvant Therapy

Outcome Measures

Primary Outcomes (1)

• Biomarker Discovery

  Changes in biomarkers from before treatment compared to during or after treatment: expression of pFGFR, pFRS2, pERK, BFGF, VEGF, FGFR1, FGFR2,VEGFR, Ki-67, Asp175, and CA9 in tumor tissue; FGFR, VEGFs, BFGF, PLGF, sVEGFR1/ 2, FGF23, GCSF, PDGF-AB, SDF-1a and SCF levels in serum

  2 years

Secondary Outcomes (2)

• Progression-free Survival

  2 years

• Safety

  2 years

Study Arms (1)

Dovitinib

EXPERIMENTAL

Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years

Drug: Dovitinib

Interventions

Dovitinib DRUG

All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years. If 500 mg is intolerable, 400 mg will be dosed. If 400 mg is intolerable, 300 mg will be dosed

Also known as: TKI258

Dovitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a confirmed diagnosis of:
• Stage 4 colon cancer either s/p metastasectomy or post-initial chemotherapy or maintenance "standard of care", either involving 5-fluorouracil/leucovorin (5-FU/LV) alone or continual bevacizumab alone. Patients in maintenance cohort must have had 2 consecutive CT scans showing stable disease and not be experiencing significant prior treatment-related toxicity above Grade 1.
• Pancreas cancer, either s/p resection and adjuvant chemotherapy or locally advanced pancreas cancer s/p chemotherapy and radiation. Initial chemotherapy or radiation therapy may have been stopped between 2 weeks and 2 months prior to study start, and patients must have recovered from prior treatment related toxicity to grade 1 or less.
• Prior surgery, including tumor resection or metastasectomy must have been performed at least 4 weeks prior to study enrollment.
• No concomitant anti-cancer treatment is allowed
• Age \>/= 18 years
• Performance status of 0-1
• Adequate hepatic, bone marrow, and renal function
• Partial thromboplastin time (PTT) must be \</= 1.5 x upper normal limit of institution's normal range and INR (International Normalized Ratio) \< 1.5.
• Life expectancy \>/= 4 months for maintenance cohorts and \>/= 6 months for adjuvant cohorts
• Women of childbearing potential must have a negative serum pregnancy test within 14 days prior to initiation of treatment and must not be lactating.
• Subject is capable of understanding and complying with protocol demands and able to sign and date the informed consent

You may not qualify if:

• Women of child-bearing potential, who are biologically able to conceive, not employing two forms of highly effective contraception or who are pregnant.
• Women who are breast-feeding
• Fertile males unwilling to use contraception
• Patients with brain metastases or any history of brain metastases
• Patients who have undergone major surgery (e.g., intra-thoracic, -abdominal, or -pelvic) \</= 4 weeks prior to starting study treatment or who have not recovered from such therapy
• Patients with a history of pulmonary embolism, or untreated deep vein thrombosis within the past 6 months
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of dovitinib
• The subject has had another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.
• Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies \</= 2 weeks prior to starting the study drug, or who have not recovered from the side effects of such therapy
• Cirrhosis, chronic active hepatitis or chronic persistent hepatitis
• Patients who are currently receiving prasugrel
• No concurrent use of isoniazid, labetolol, trovafloxacin, tolcapone, and felbamate
• No concurrent use of other investigational drugs or antineoplastic therapies.
• Patients with impaired cardiac function or clinically significant cardiac diseases.

Sponsors & Collaborators

• Georgetown University: lead
• Novartis: collaborator

Study Sites (1)

Georgetown University- Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Pancreatic Neoplasms

Interventions

4-amino-5-fluoro-3-(5-(4-methylpiperazin-1-yl)-1H-benzimidazol-2-yl)quinolin-2(1H)-one

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: John L Marshall
• Organization: Georgetown Lombardi Comprehensive Cancer Center

marshalj@georgetown.edu

202 444 7064

Study Officials

• John L Marshall, MD

  Georgetown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: June 28, 2013
• Study Start: October 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 19, 2016
• Results First Posted: July 19, 2016

Record last verified: 2015-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)