Tumor Response
Primary
· Every other cycle
Complete and Partial Tumor Response by (Response Evaluation Criteria in Solid Tumors) RECIST 1.0
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 15.4 | 7.9 – 26.1 |
Last reviewed · How we verify
NCT00551070
Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer
Completed
Phase 2
Results posted
Last updated 3 December 2020
What this trial tests
Phase 2 trial testing Laboratory Biomarker Analysis in Borderline Ovarian Serous Tumor in 52 participants. Completed in 13 November 2020.
Timeline
17 December 2007
Primary endpoint
23 July 2013
23 July 2013
13 November 2020
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 17 December 2007 |
| Primary completion | 23 July 2013 |
| Estimated completion | 13 November 2020 |
| Sites | 49 locations across United States |
Drugs / interventions tested
- Laboratory Biomarker Analysis — full drug profile →
- Pharmacological Study — full drug profile →
- Selumetinib — full drug profile →
- Selumetinib Sulfate — full drug profile →
Conditions studied
- Borderline Ovarian Serous Tumor — all drugs for Borderline Ovarian Serous Tumor →
- Low Grade Ovarian Serous Adenocarcinoma — all drugs for Low Grade Ovarian Serous Adenocarcinoma →
- Micropapillary Serous Carcinoma — all drugs for Micropapillary Serous Carcinoma →
- Primary Peritoneal Carcinoma — all drugs for Primary Peritoneal Carcinoma →
Sponsor
National Cancer Institute (NCI)
Who can join
19 and older, female only, with Borderline Ovarian Serous Tumor or Low Grade Ovarian Serous Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival
Secondary
· Every other cycle
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 11.3 | 6.2 – 12.9 |
Number of Courses Received
Secondary
· Every cycle
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 5 | 2 – 14 |
Adverse Events (Grade 3 or Higher) During First Cycle of Treatment
Primary
· Cycle 1
Leukopenia
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 0 | 0 – 7 |
Thrombocytopenia
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 0 | 0 – 7 |
Neutropenia
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 0 | 0 – 7 |
Anemia
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 2 | 0 – 10 |
Allergy/Immunology
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 0 | 0 – 7 |
Auditory/Ear
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 0 | 0 – 7 |
Cardiac
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 2 | 0 – 10 |
Coagulation
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 0 | 0 – 7 |
Area Under the Curve (AUC) for AZD6244, 100 mg Administered Orally Twice Daily.
Primary
· Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 2419 | 1673 – 3186 |
Maximum Concentration (Cmax) for AZD6244, 100 mg Administered Orally Twice Daily.
Primary
· Pre-dose, and 1, 3, and 6 hours after administration of drug on Day 7 after the start of AZD6244 treatment
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 585 | 371 – 1100 |
Overall Survival
Secondary
· Every cycle during treatment, then every 3 months for the first 2 years, then every six months for the next three years and then annually for the next 5 years
| Group | Value | 95% CI |
|---|---|---|
| AZD6244 | 32.4 | 17.7 – 39.3 |
Adverse events — posted to ClinicalTrials.gov
Time frame: Study Treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
AZD6244
Serious: 33/52 (63%)
Deaths: —
Serious adverse events (33 terms)
| Reaction | System | AZD6244 |
|---|---|---|
| Obstruction, Gi - Small Bowel Nos | Gastrointestinal disorders | — |
| Pain: Abdominal Pain Nos | General disorders | — |
| Mucositis (Clinical Exam) - Oral Cavity | Gastrointestinal disorders | — |
| Hypertension | Cardiac disorders | — |
| Weight Gain | General disorders | — |
| Obstruction, Gi - Colon | Gastrointestinal disorders | — |
| Mucositis (Functional/Sympt) - Oral Cavity | Gastrointestinal disorders | — |
| Dehydration | Gastrointestinal disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Inf W/Nml Or Gr 1 Or 2 Anc: Skin(Cellulitis) | Infections and infestations | — |
| Alt | Metabolism and nutrition disorders | — |
| Leukocytes | Blood and lymphatic system disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Prolonged Qtc Interval | Cardiac disorders | — |
| S/N Arrhythmia: Sinus Bradycardia | Cardiac disorders | — |
| Hypotension | Cardiac disorders | — |
| Death No Ctcae Term - Disease Progression Nos | General disorders | — |
| Ulcer,gi - Esophagus | Gastrointestinal disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Gastrointestinal - Other | Gastrointestinal disorders | — |
| Stricture, Gi - Biliary Tree | Gastrointestinal disorders | — |
| Hemorrhage, Gi - Rectum | Vascular disorders | — |
| Inf W/Nml Or Gr 1 Or 2 Anc: Lung(Pneumonia) | Infections and infestations | — |
| Inf Unknown Anc: Wound | Infections and infestations | — |
Other adverse events (142 terms — click to expand)
| Reaction | System | AZD6244 |
|---|---|---|
| Diarrhea | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Rash | Skin and subcutaneous tissue disorders | — |
| Hemoglobin | Blood and lymphatic system disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Edema: Limb | Blood and lymphatic system disorders | — |
| Ast | Metabolism and nutrition disorders | — |
| Alt | Metabolism and nutrition disorders | — |
| Neuropathy-Sensory | Nervous system disorders | — |
| Pain: Abdominal Pain Nos | General disorders | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — |
| Constipation | Gastrointestinal disorders | — |
| Alkaline Phosphatase | Metabolism and nutrition disorders | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| Anorexia | Gastrointestinal disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Hypokalemia | Metabolism and nutrition disorders | — |
| Leukocytes | Blood and lymphatic system disorders | — |
| Weight Gain | General disorders | — |
| Neutrophils | Blood and lymphatic system disorders | — |
| Hair Loss/Alopecia (Scalp Or Body) | Skin and subcutaneous tissue disorders | — |
| Acne | Skin and subcutaneous tissue disorders | — |
| Dry Skin | Skin and subcutaneous tissue disorders | — |
| Mucositis (Clinical Exam) - Oral Cavity | Gastrointestinal disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Mood Alteration - Anxiety | Nervous system disorders | — |
| Pain: Head/Headache | General disorders | — |
| Creatinine | Metabolism and nutrition disorders | — |
| Pain: Extremity-Limb | General disorders | — |
| Hyponatremia | Metabolism and nutrition disorders | — |
| Pain: Back | General disorders | — |
| Platelets | Blood and lymphatic system disorders | — |
| Insomnia | General disorders | — |
| Hypertension | Cardiac disorders | — |
| Fever | General disorders | — |
| Metabolic/Laboratory - Other | Metabolism and nutrition disorders | — |
| Hypocalcemia | Metabolism and nutrition disorders | — |
| Mood Alteration - Depression | Nervous system disorders | — |
| Pain: Joint | General disorders | — |
Most-reported serious reactions: Obstruction, Gi - Small Bowel Nos, Pain: Abdominal Pain Nos, Mucositis (Clinical Exam) - Oral Cavity, Hypertension, Weight Gain, Obstruction, Gi - Colon, Mucositis (Functional/Sympt) - Oral Cavity, Dehydration.
Data from ClinicalTrials.gov NCT00551070 adverse events section.
Sponsor's own description
This phase II trial studies the side effects and how well selumetinib sulfate works in treating patients with low-grade ovarian cancer that has come back (recurrent). Selumetinib sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
The MAPK pathway across different malignancies: a new perspective.
Burotto M, Chiou VL, Lee JM, Kohn EC. · · 2014 · cited 773× · PMID 24948110 · DOI 10.1002/cncr.28864 -
Selumetinib in women with recurrent low-grade serous carcinoma of the ovary or peritoneum: an open-label, single-arm, phase 2 study.
Farley J, Brady WE, Vathipadiekal V, Lankes HA, et al · · 2013 · cited 289× · PMID 23261356 · DOI 10.1016/s1470-2045(12)70572-7 -
Targeted therapies in gynecological cancers: a comprehensive review of clinical evidence.
Wang Q, Peng H, Qi X, Wu M, et al · · 2020 · cited 114× · PMID 32728057 · DOI 10.1038/s41392-020-0199-6 -
Proteomics and biomarkers in clinical trials for drug development.
Lee JM, Han JJ, Altwerger G, Kohn EC. · · 2011 · cited 47× · PMID 21570499 · DOI 10.1016/j.jprot.2011.04.023 -
The insulin-like growth factor 1 pathway is a potential therapeutic target for low-grade serous ovarian carcinoma.
King ER, Zu Z, Tsang YT, Deavers MT, et al · · 2011 · cited 44× · PMID 21726895 · DOI 10.1016/j.ygyno.2011.06.016 -
Differences in MEK inhibitor efficacy in molecularly characterized low-grade serous ovarian cancer cell lines.
Fernández ML, DiMattia GE, Dawson A, Bamford S, et al · · 2016 · cited 35× · PMID 27822414 -
IGF2BP1 is a targetable SRC/MAPK-dependent driver of invasive growth in ovarian cancer.
Bley N, Schott A, Müller S, Misiak D, et al · · 2021 · cited 32× · PMID 32876513 · DOI 10.1080/15476286.2020.1812894 -
Current and Emerging Molecular Therapies for Head and Neck Squamous Cell Carcinoma.
Kordbacheh F, Farah CS. · · 2021 · cited 25× · PMID 34771633 · DOI 10.3390/cancers13215471
Verify or expand the search:
- PubMed search for NCT00551070
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
Data sources for this page
- Trial protocol + status: ClinicalTrials.gov NCT00551070 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
- Last refreshed: 3 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00551070.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing