A Phase II Study to Evaluate the Efficacy of TKI258 for the Treatment of Patients With FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer
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| ClinicalTrials.gov Identifier: NCT01379534 |
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Recruitment Status :
Completed
First Posted : June 23, 2011
Results First Posted : March 31, 2015
Last Update Posted : May 20, 2015
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Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
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Brief Summary:
This is a prospective, multi-center, open-label, single-arm, non-randomized, Phase II study to evaluate the efficacy and safety of TKI258 as second-line therapy in patients with either FGFR2 mutated or wild-type advanced and/or metastatic endometrial cancer.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Solid Tumors and Advanced Endometrial Cancer Endometrial Cancer Second-line Treatment VEGF | Drug: TKI258 | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 53 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Open-label, Single-arm, Non-randomized, Multi-center Study to Evaluate the Efficacy of Oral TKI258 as Second-line Therapy in Patients With Either FGFR2 Mutated or Wild-type Advanced and/or Metastatic Endometrial Cancer |
| Study Start Date : | November 2011 |
| Actual Primary Completion Date : | March 2014 |
| Actual Study Completion Date : | March 2014 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: TKI258
1 treatment arm (single agent TKI258), with patients classified into 2 groups based on their FGFR2 mutation status
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Drug: TKI258
Other Name: dovitinib |
Primary Outcome Measures :
- Progression Free Survival (PFS) Rate [ Time Frame: up to 18 weeks ]The 18-week PFS was defined as the percentage of participants who did not have a progression event at week 18. Participants who progressed, died, had response assessment of unknown (UNK) or discontinued before 18 weeks of observation without progression were counted as "failure". Progressive disease was assessed as per investigator assessment using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Secondary Outcome Measures :
- Overall Response Rate (ORR) [ Time Frame: Baseline and every 6 weeks until disease progression, up to 18 weeks ]ORR is defined as the percentage of participants with a best overall response of complete response (CR) or partial response (PR).
- Disease Control Rate (DCR) [ Time Frame: Baseline and every 6 weeks until disease progression, up to 18 weeks ]DCR was defined as the percentage of participants with a best overall response of CR or PR or stable disease (SD).
- Duration of Response (DR) [ Time Frame: up to 18 weeks ]Duration of response was defined for participants with a CR or PR as the time from the date of the first documented response (CR or PR) to the date of the first documented progression or death due to disease. If a participants did not have a progression event, duration of response was censored at the date of the last adequate tumor assessment before the data analysis cut-off date or the antineoplastic therapy start date or the death date.
- Overall Survival (OS) [ Time Frame: up to 18 weeks ]OS was defined as the time from date of treatment to the date of death from any cause. If a participant was not known to have died at the date of analysis cut-off, the OS was censored at the last date of contact.
- Progression Free Survival (PFS) [ Time Frame: up to 18 weeks ]PFS was defined as the time from the date of start of treatment to the date of the first documented progression or death due to any cause. If a participant did not have an event, PFS was censored at the date of last adequate response assessment before the data analysis cut-off date or the start date of new antineoplastic therapy after study drug discontinuation.
- Number of Participants With Adverse Events, Serious Adverse Events and Deaths [ Time Frame: up to 30 days after the last dose of study drug, up to 18 weeks ]Adverse event monitoring was conducted throughout the study.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with histologically confirmed diagnosis of advanced and/or metastatic endometrial cancer with available tissue specimen (either archival tissue or fixed fresh biopsy)
- Female patients ≥ 18 years old
- Documented radiologically confirmed progression of disease after prior first-line treatment evidence of progressive disease
- ECOG (Eastern Cooperative Oncology Group) performance status ≤ 2
- At least one measurable lesion as per RECIST
Exclusion Criteria:
- Previous treatment with an FGFR inhibitor
- More than one line of treatment for advanced or metastatic disease
- Patients with uterine sarcomas, adenosarcoma, and malignant Mullerian tumors
- Patients with isolated recurrences (vaginal, pelvic, or para-aortic) potentially curative with radiation therapy or surgery
- Known central nervous system (CNS) metastases
- Malignancy within 3 years of study enrollment Other protocol-defined inclusion/exclusion criteria may apply
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01379534
Show 45 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Novartis Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01379534 History of Changes |
| Other Study ID Numbers: |
CTKI258A2211 2011-000266-35 ( EudraCT Number ) |
| First Posted: | June 23, 2011 Key Record Dates |
| Results First Posted: | March 31, 2015 |
| Last Update Posted: | May 20, 2015 |
| Last Verified: | May 2015 |
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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Solid tumors, advanced endometrial cancer, Endometrial Cancer, Second-line treatment, VEGF, Neoplasms, Endometrial Neoplasms, Uterine Neoplasms, Female Genital Neoplasms, Cancer, Carcinoma, Uterine Diseases, |
Female Genital Diseases, Tumors, Oral Administration, Capsules, Tablets, CHIR258, CHIR-258, CHIR 258, TKI258, TKI-258, TKI 258 |
Additional relevant MeSH terms:
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Endometrial Neoplasms Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms |
Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female |