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Paclitaxel and Ganetespib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Phase 1, PHASE2 trial testing paclitaxel in Recurrent Fallopian Tube Cancer in 12 participants. Terminated before completion.
| Lead sponsor | Fox Chase Cancer Center |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 9 October 2013 |
| Primary completion | 9 May 2016 |
| Estimated completion | 6 July 2018 |
| Sites | 2 locations across United States |
Fox Chase Cancer Center — full company profile →
18 and older, female only, with Recurrent Fallopian Tube Cancer or Recurrent Ovarian Epithelial Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
| Group | Value | 95% CI |
|---|---|---|
| Treatment (Paclitaxel, Ganetespib) | 150 |
Time frame: 2.5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Phase 1: 100 mg/m2 Ganetes… | Phase 1: 125 mg/m2 Ganetes… | Phase 1: 150 mg/m2 Ganetes… | Phase II: MTD/MED of Ganet… |
|---|---|---|---|---|---|
| Fatigue | General disorders | — | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Hypertension | Cardiac disorders | — | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — | — |
| Dry mouth | Gastrointestinal disorders | — | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — | — | — |
| Insomnia | Psychiatric disorders | — | — | — | — |
| Neutropenia | Blood and lymphatic system disorders | — | — | — | — |
| Edema | Blood and lymphatic system disorders | — | — | — | — |
| Depression | Psychiatric disorders | — | — | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Sweats | General disorders | — | — | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — | — |
| Ascite | Gastrointestinal disorders | — | — | — | — |
| Bloating | Gastrointestinal disorders | — | — | — | — |
| Flatulence | Gastrointestinal disorders | — | — | — | — |
| Gait disturbance | General disorders | — | — | — | — |
| Malaise | General disorders | — | — | — | — |
| Headache | Nervous system disorders | — | — | — | — |
| Tremor | Nervous system disorders | — | — | — | — |
| Alkaline phosphatase increased | Investigations | — | — | — | — |
| Hypomagnesemia | Metabolism and nutrition disorders | — | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — | — |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — | — | — |
| Thromboembolic event | Vascular disorders | — | — | — | — |
| Upper respiratory infection | Infections and infestations | — | — | — | — |
Data from ClinicalTrials.gov NCT01962948 adverse events section.
This phase I/II trial studies the side effects and best dose of ganetespib when given together with paclitaxel and to see how well they work in treating patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Ganetespib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving paclitaxel and ganetespib may be an effective treatment for ovarian, fallopian tube, or primary peritoneal cancer.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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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/NCT01962948.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing