Study Of AG-013736 (Axitinib) As Second-Line Treatment In Patients With Metastatic Renal Cell Cancer (mRCC)

NCT00569946 | Completed Phase 2 Results

• 1 other identifier: A4061035
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 18

Brief Summary

To investigate objective tumor response of AG-013736 for metastatic Renal Cell Cancer (mRCC)

Conditions

Carcinoma, Renal Cell

Keywords

AG-013736; RCC; Phase 2

Outcome Measures

Primary Outcomes (2)

• Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Independent Review Committee Assessment

  Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the Independent Review Committee, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.

  Up to 765 days of treatment at the data cut-off date

• Objective Response Rate (Percentage of Participants With Complete Response [CR] or Partial Response [PR]): Investigators Assessment

  Percentage of participants with objective response based assessment of confirmed CR or confirmed PR by the investigator, according to Response Evaluation Criteria in Solid Tumors (RECIST Version 1.0). CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters of the targeted lesions. CR and PR had to be documented on 2 occasions separated by at least 4 weeks.

  Up to 765 days of treatment at the data cut-off date

Secondary Outcomes (11)

• Progression-Free Survival (PFS)

  Up to 1709 days of treatment

• Time to Tumor Progression (TTP)

  Up to 1709 days of treatment

• Duration of Response

  Start of first confirmed CR or PR to the date of the first event (PD or death) or the last tumor assessment, whichever came first, assessed up to 1709 days.

• Overall Survival (OS)

  Up to 2002 days (maximum duration of treatment plus follow-up observation)

• Number of Participants Analyzed for Population Pharmacokinetics of AG-013736

  Cycle 1 Day 1 (2 hours after morning dose); Cycles 3, 5, and 7 Day 1 predose and 2 hours post morning dose

Study Arms (1)

AG-013736

EXPERIMENTAL

Drug: AG-013736

Interventions

AG-013736 DRUG

AG-013736 5 mg BID will be administered orally on continuous schedule. Cycle length is 28 days. If the drug is well tolerated at 5 mg BID, the dose of AG-013736 may be titrated to 7 mg BID and then to a maximum of 10 mg BID. Number of cycles: until progression or unacceptable toxicity develops.

AG-013736

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients histologically diagnosed as metastatic renal cell cancer with a component of clear cell cancer.
• Patients who are refractory to cytokine therapy as 1st line.
• Patients who experienced nephrectomy.
• Patients with at least 1 target lesion, as defined by RECIST.
• Patients with no uncontrolled hypertension.

You may not qualify if:

• Gastrointestinal abnormalities
• Current use or anticipated inability to avoid potent CYP3A4 inhibitors or CYP1A2/3A4 inducers.
• Active seizure disorder or evidence of brain metastases.
• Patients with hemoptysis.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (18)

National Cancer Center East Hospital

Kashiwa, Chiba, 277-8577, Japan

Location

Hokkaido University Hospital

Sapporo, Hokkaido, 060-8648, Japan

Location

Tsukuba University Hospital

Tsukuba, Ibaraki, 305-8576, Japan

Location

Iwate Medical University

Morioka, Iwate, 020-8505, Japan

Location

Kochi Medical School Hospital

Nankoku-shi, Kochi, 783-8505, Japan

Location

Kinki University Hospital

Sayama, Osaka, 589-8511, Japan

Location

Hamamatsu University School of Medicine University Hospital

Hamamatsu, Shizuoka, 431-3192, Japan

Location

Shizuoka Cancer Center

Sunto-gun, Shizuoka, 411-8777, Japan

Location

Tokyo Women's Medical University Medical Center East

Arakawa-ku, Tokyo, 116-8567, Japan

Location

National Cancer Center

Chuo-ku, Tokyo, 104-8503, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

Location

Akita University Hospital

Akita, 010-8543, Japan

Location

National Kyushu Cancer Center

Fukuoka, 811-1395, Japan

Location

Kyushu University Hospital, Department of Urology

Fukuoka, 812-8582, Japan

Location

University Hospital, Kyoto Prefectural University of Medicine

Kyoto, 602-8566, Japan

Location

Osaka University Hospital

Osaka, 565-0871, Japan

Location

Tokushima University Hospotal

Tokushima, 770-8503, Japan

Location

Yamagata University Hospital

Yamagata, 990-9585, Japan

Location

Related Publications (3)

• Schindler E, Amantea MA, Karlsson MO, Friberg LE. A Pharmacometric Framework for Axitinib Exposure, Efficacy, and Safety in Metastatic Renal Cell Carcinoma Patients. CPT Pharmacometrics Syst Pharmacol. 2017 Jun;6(6):373-382. doi: 10.1002/psp4.12193. Epub 2017 May 26.

  PMID: 28378918 DERIVED

• Eto M, Uemura H, Tomita Y, Kanayama H, Shinohara N, Kamei Y, Fujii Y, Umeyama Y, Ozono S, Naito S, Akaza H; Japan Axitinib Phase II Study Group. Overall survival and final efficacy and safety results from a Japanese phase II study of axitinib in cytokine-refractory metastatic renal cell carcinoma. Cancer Sci. 2014 Dec;105(12):1576-83. doi: 10.1111/cas.12546. Epub 2014 Nov 25.

  PMID: 25283266 DERIVED

• Tomita Y, Uemura H, Fujimoto H, Kanayama HO, Shinohara N, Nakazawa H, Imai K, Umeyama Y, Ozono S, Naito S, Akaza H; Japan Axitinib Phase II Study Group. Key predictive factors of axitinib (AG-013736)-induced proteinuria and efficacy: a phase II study in Japanese patients with cytokine-refractory metastatic renal cell Carcinoma. Eur J Cancer. 2011 Nov;47(17):2592-602. doi: 10.1016/j.ejca.2011.07.014. Epub 2011 Aug 31.

  PMID: 21889330 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Axitinib

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Indazoles; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2007
• First Posted: December 10, 2007
• Study Start: December 12, 2007
• Primary Completion: February 26, 2010
• Study Completion: October 30, 2012
• Last Updated: June 5, 2019
• Results First Posted: March 27, 2012

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share

Locations

JP (18)