Dovitinib Plus Docetaxel in Gastric Cancer

NCT ID: NCT01921673

Last Updated: 2017-07-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2016-10-31

Brief Summary

Docetaxel is currently one of standard second-line therapy in patients with gastric cancer. As angiogenesis and FGFR pathway has been suggested to be associated with gastric cancer, dovitinib, dual VEGFR and FGFR inhibitor, may have the potential to improve the outcomes of patients with gastric cancer. Therefore, we investigated the combination regimen of docetaxel and dovitinib.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dovitinib plus docetaxel

In phase I portion of the study Docetaxel 45-75 mg/m2, intravenous, every 3 weeks Dovitinib 200-500 mg, oral, 5 days on/2 days off

In phase II portion of the study Recommended dose of docetaxel and dovitinib in phase I portion will be used.

Group Type: EXPERIMENTAL

Dovitinib and docetaxel

Intervention Type: DRUG

In phase I portion of the study Docetaxel 45-75 mg/m2, intravenous, every 3 weeks Dovitinib 200-500 mg, oral, 5 days on/2 days off

In phase II portion of the study Recommended dose of docetaxel and dovitinib in phase I portion will be used.

Interventions

Dovitinib and docetaxel

In phase I portion of the study Docetaxel 45-75 mg/m2, intravenous, every 3 weeks Dovitinib 200-500 mg, oral, 5 days on/2 days off

In phase II portion of the study Recommended dose of docetaxel and dovitinib in phase I portion will be used.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Pathologically proven metastatic or unresectable adenocarcinoma of stomach or gastroesophageal junction

2. Patients with progressive disease (radiological confirmation required) after one line of chemotherapy except taxane for advanced gastric cancer in palliative setting

3. Presence of at least one evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

4. Age of 18 to 74 years

5. Estimated life expectancy of more than 3 months

6. Eastern Cooperative Oncology Group (ECOG) performance status 0~2

7. Adequate bone marrow function (Absolute neutrophil counts ≥ 1,500/uL, hemoglobin ≥ 8.0g/dL, and platelet ≥ 100,000/uL)

8. Adequate renal function (creatinine < 1.5mg/dL)

9. Adequate hepatic function (total bilirubin < 1.5 mg/dL, transaminase < 3 times the upper normal limit [5 times for patients with liver metastasis])

10. No prior anti-angiogenic therapy (anti-VEGF or VEGFR tyrosine kinase inhibitor etc) or FGF/FGFR inhibitor

11. No prior radiation therapy within 4 weeks of the study (Irradiated lesions should not be included in the evaluable lesions.)

12. Written informed consent

Exclusion Criteria

1. Past or concurrent history of neoplasm other than gastric adenocarcinoma, except for curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix uteri

2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start

3. Bowel obstruction

4. Evidence of serious gastrointestinal bleeding

5. Presence of central nervous system (CNS) metastasis

6. History of significant neurologic or psychiatric disorders

7. Significant cardiac disease within 6 months of the study (congestive heart failure uncontrollable by medication, symptomatic coronary heart disease, or arrhythmia, myocardial infarction)

8. Left ventricular ejection fraction (LVEF) assessed by 2-D echocardiogram (ECHO) or multiple gated acquisition scan (MUGA), < 45%

9. Uncontrolled hypertension defined by a SBP ≥ 160 mm Hg and/or DBP ≥ 100 mm Hg, with or without anti-hypertensive medication. Initiation or adjustment of antihypertensive medication (s) is allowed prior to study entry.

10. QTc > 480 msec on screening ECG

11. Proteinuria defined by NCI CTCAE grade > 1 at baseline as measured by a urine dipstick (2+ or greater) and confirmed by a 24 hour urine collection ( > 1g/24hrs). Subjects may be re-screened if blood pressure is shown to be controlled with or without intervention

12. History of thrombotic or bleeding diathesis or coagulopathy

13. Serious non-healing wound, peptic ulcer, or bone fracture

14. Abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months

15. Pregnant or lactating women, women of childbearing potential not employing adequate contraception

16. Other serious illness or medical conditions

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Asan Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Yoon-Koo Kang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yoon-Koo Kang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

Asan Medical Center

Seoul, , South Korea

Countries

South Korea

References

Lee JL, Ryu MH, Chang HM, Kim TW, Yook JH, Oh ST, Kim BS, Kim M, Chun YJ, Lee JS, Kang YK. A phase II study of docetaxel as salvage chemotherapy in advanced gastric cancer after failure of fluoropyrimidine and platinum combination chemotherapy. Cancer Chemother Pharmacol. 2008 Apr;61(4):631-7. doi: 10.1007/s00280-007-0516-6. Epub 2007 May 23.

Reference Type: BACKGROUND

PMID: 17520252 (View on PubMed)

Wesche J, Haglund K, Haugsten EM. Fibroblast growth factors and their receptors in cancer. Biochem J. 2011 Jul 15;437(2):199-213. doi: 10.1042/BJ20101603.

Reference Type: BACKGROUND

PMID: 21711248 (View on PubMed)

Yamamoto S, Yasui W, Kitadai Y, Yokozaki H, Haruma K, Kajiyama G, Tahara E. Expression of vascular endothelial growth factor in human gastric carcinomas. Pathol Int. 1998 Jul;48(7):499-506. doi: 10.1111/j.1440-1827.1998.tb03940.x.

Reference Type: BACKGROUND

PMID: 9701011 (View on PubMed)

Other Identifiers

AMC1302

Identifier Type: -

Identifier Source: org_study_id