Phase 2 Study of S-1 in Advanced or Metastatic Pancreatic Cancer

NCT00651742 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TPU-S1204
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether S-1 is effective in slowing tumor activity in participants with locally advanced or metastatic pancreatic cancer who have not had chemotherapy. The study is also looking at the safety of S-1.

Conditions

Locally Advanced or Metastatic Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Overall Tumor Response Rate (ORR)

  ORR was defined as the percentage of participants with objective evidence of partial response (PR) or complete response (CR) and was based on the best overall response across all cycles for each participant. Tumor response was assessed according to the Response Evaluation Criteria In Solid Tumors (RECIST). For target lesions response, CR was defined as the disappearance of all target lesions for at least 3 weeks and PR was defined as at least a 30% reduction in the sum of the longest diameters of the target lesions, taking as a reference the baseline sum of the longest diameters for at least 6 weeks. For non-target lesions, CR was defined the disappearance of all non-target lesions and normalization of tumor marker level for at least 6 weeks.

  From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months

Secondary Outcomes (8)

• Disease Control Rate (DCR)

  From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months

• Duration of Response (DR)

  From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months

• Time to Tumor Progression (TTP)

  From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months

• Overall Survival (OS)

  From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months

• Progression-free Survival (PFS)

  From first dose of study medication until disease progression, permanent discontinuation of study treatment, or death due to any cause, assessed up to 2 years 5 months

Study Arms (1)

S-1 30 mg/m^2

EXPERIMENTAL

Participants received 30 milligrams per meter square (mg/m\^2) of S-1 orally twice daily (BID) for 2 weeks (i.e., Day 1 to 14), followed by 1 week recovery period (i.e., Day 15 to 21; one cycle equaled 21 days), treatment was repeated every 3 weeks until death, progression of disease, occurrence of intolerable side effects, withdrawal of consent, or removal by Investigator, whichever comes first.

Drug: S-1

Interventions

S-1 DRUG

All participants received S-1 orally at a dose of 30 mg/m2 BID for 14 days followed by a 1-week recovery period, repeated every 3 weeks. The trial was planned to proceed to the second stage only if sufficient efficacy was demonstrated in Stage 1.

S-1 30 mg/m^2

Eligibility Criteria

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

You may qualify if:

• Has provided written informed consent.
• Has histologically or cytologically confirmed locally advanced, unresectable or metastatic adenocarcinoma of the pancreas not amenable to curative radiotherapy or surgery.
• Has measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria (ie, lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20 mm using conventional techniques or ≥ 10 mm using spiral computed tomography \[CT\] scan).
• Is able to take medications orally.
• Is 18 years of age or older.
• Has a Karnofsky Performance Status (KPS) ≥ 70%.
• Has a life expectancy of ≥ 12 weeks.
• Has adequate organ function as defined by the following criteria:
• Transaminases AST (SGOT) and ALT (SGPT) ≤ 2.5 times the upper limit of normal (ULN). If liver function abnormalities are due to underlying liver metastasis, then AST (SGOT) and ALT (SGPT) may be ≤ 5 times ULN.
• Total serum bilirubin ≤ 3.0 times ULN (if due to underlying liver metastasis, then total bilirubin may be ≤ 5 times ULN).
• Absolute granulocyte count ≥ 1,500/mm3 (ie, ≥ 1.5 x 109/L by International Units \[IU\]).
• Platelet count ≥ 100,000/mm3 (IU: ≥ 100 x 109/L).
• Hemoglobin value ≥ 9.0 g/dL.
• Calculated creatinine clearance ≥ 60 mL/min (based on serum creatinine) (Cockcroft-Gault85 formula)
• Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

You may not qualify if:

• Has had treatment with any of the following within the specified time frame prior to study drug administration:
• Any prior anticancer chemotherapy.
• Radiation therapy to a target lesion unless there was evidence of PD after radiotherapy (and this target lesion must not be the only site of measurable disease).
• Any radiotherapy within the previous 3 weeks.
• Any investigational agent received either concurrently or within the last 30 days.
• Current enrollment in another clinical study with an investigational agent. Patients participating in surveys or observational studies are eligible to participate in this study.
• Major surgery within the previous 3 weeks.
• Symptomatic brain metastasis not controlled by corticosteroids.
• Leptomeningeal metastasis.
• Previous or concurrent malignancy other than pancreatic cancer except adequately treated carcinoma in-situ of the cervix or non-melanoma skin cancer.
• Uncontrolled ascites requiring drainage at least twice a week.
• Other serious illness or medical condition(s) including, but not limited to, the following:
• Uncontrolled congestive heart failure (New York Heart Association \[NYHA\] Class III or IV), angina pectoris, arrhythmias, or hypertension.
• Active infection.
• Known (at time of entry) gastrointestinal disorder, including malabsorption, chronic nausea, vomiting, or diarrhea, present to the extent that it might interfere with oral intake and absorption of study medication.

Sponsors & Collaborators

• Taiho Oncology, Inc.: lead
• Quintiles, Inc.: collaborator
• United BioSource, LLC: collaborator

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

S 1 (combination)

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Limitations and Caveats

Since the pre-defined tumor response futility criteria was not exceeded in Stage 1, participant enrollment for Stage 2 was not conducted, as pre-planned in the protocol.

Results Point of Contact

• Title: Taiho
• Organization: Taiho Oncology, Inc

medicalinformation@taihooncology.com

+1 844-878-2446

Study Officials

• Taiho Central

  Taiho Oncology, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: January 9, 2006
• Primary Completion: July 8, 2008
• Study Completion: July 8, 2008
• Last Updated: September 19, 2024
• Results First Posted: December 10, 2021

Record last verified: 2024-08